24 results on '"Haralabos Eleftheriadis"'
Search Results
2. Standard threshold laser versus subthreshold micropulse laser for adults with diabetic macular oedema: the DIAMONDS non-inferiority RCT
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Noemi Lois, Christina Campbell, Norman Waugh, Augusto Azuara-Blanco, Mandy Maredza, Hema Mistry, Danny McAuley, Nachiketa Acharya, Tariq M Aslam, Clare Bailey, Victor Chong, Louise Downey, Haralabos Eleftheriadis, Samia Fatum, Sheena George, Faruque Ghanchi, Markus Groppe, Robin Hamilton, Geeta Menon, Ahmed Saad, Sobha Sivaprasad, Marianne Shiew, David H Steel, James Stephen Talks, Paul Doherty, Clíona McDowell, and Mike Clarke
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diabetic macular edema ,dme ,diabetic macular oedema ,dmo ,diabetes ,laser ,micropulse ,subthreshold laser ,photocoagulation ,randomised clinical trial ,rct ,vascular endothelial growth factor ,vegf ,anti-vegfs ,ranibizumab ,aflibercept ,bevacizumab ,steroids ,cost-effectiveness ,eq5d-5l ,eq5d ,visqol ,nei vfq25 ,qol ,quality of life ,Medical technology ,R855-855.5 - Abstract
Background: The National Institute for Health and Care Excellence recommends macular laser to treat diabetic macular oedema with a central retinal subfield thickness of 24 Early Treatment Diabetic Retinopathy Study letters (Snellen equivalent > 20/320) in one/both eyes. Interventions: Participants were randomised 1 : 1 to receive 577 nm subthreshold micropulse laser or standard threshold macular laser (e.g. argon laser, frequency-doubled neodymium-doped yttrium aluminium garnet 532 nm laser); laser treatments could be repeated as needed. Rescue therapy with intravitreal anti-vascular endothelial growth factor therapies or steroids was allowed if a loss of ≥ 10 Early Treatment Diabetic Retinopathy Study letters between visits occurred and/or central retinal subfield thickness increased to > 400 µm. Main outcome measures: The primary outcome was the mean change in best-corrected visual acuity in the study eye at 24 months (non-inferiority margin 5 Early Treatment Diabetic Retinopathy Study letters). Secondary outcomes included the mean change from baseline to 24 months in the following: binocular best-corrected visual acuity; central retinal subfield thickness; the mean deviation of the Humphrey 10–2 visual field in the study eye; the percentage of people meeting driving standards; and the EuroQol-5 Dimensions, five-level version, National Eye Institute Visual Function Questionnaire – 25 and Vision and Quality of Life Index scores. Other secondary outcomes were the cost per quality-adjusted life-years gained, adverse effects, number of laser treatments and additional rescue treatments. Results: The DIAMONDS trial recruited fully (n = 266); 87% of participants in the subthreshold micropulse laser group and 86% of participants in the standard threshold macular laser group had primary outcome data. Groups were balanced regarding baseline characteristics. Mean best-corrected visual acuity change in the study eye from baseline to month 24 was –2.43 letters (standard deviation 8.20 letters) in the subthreshold micropulse laser group and –0.45 letters (standard deviation 6.72 letters) in the standard threshold macular laser group. Subthreshold micropulse laser was deemed to be not only non-inferior but also equivalent to standard threshold macular laser as the 95% confidence interval (–3.9 to –0.04 letters) lay wholly within both the upper and lower margins of the permitted maximum difference (5 Early Treatment Diabetic Retinopathy Study letters). There was no statistically significant difference between groups in any of the secondary outcomes investigated with the exception of the number of laser treatments performed, which was slightly higher in the subthreshold micropulse laser group (mean difference 0.48, 95% confidence interval 0.18 to 0.79; p = 0.002). Base-case analysis indicated no significant difference in the cost per quality-adjusted life-years between groups. Future work: A trial in people with ≥ 400 µm diabetic macular oedema comparing anti-vascular endothelial growth factor therapy alone with anti-vascular endothelial growth factor therapy and macular laser applied at the time when central retinal subfield thickness has decreased to
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- 2022
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3. Estimating excess visual loss from neovascular age-related macular degeneration in the UK during the COVID-19 pandemic: a retrospective clinical audit and simulation model
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Anthony Khawaja, Andrew Lotery, Adnan Tufail, Paul Taylor, Philipp L Müller, Sudeshna Patra, R Khan, E Wilkinson, B Paul, Haralabos Eleftheriadis, Robin Hamilton, S George, V Kumar, R Mukherjee, C Jones, Abraham Olvera-Barrios, Catherine Egan, Roy Schwartz, C Brand, H Palmer, Alasdair Warwick, C Bailey, U Chakravarthy, F Ghanchi, S Mahmood, A Davis, L Downey, G Menon, N Dhingra, R Antcliff, A Lobo, A Patwardhan, T Akerele, Darren S Thomas, Ella Preston, P Lip, S Natha, and J Talks
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Medicine - Abstract
Objectives To report the reduction in new neovascular age-related macular degeneration (nAMD) referrals during the COVID-19 pandemic and estimate the impact of delayed treatment on visual outcomes at 1 year.Design Retrospective clinical audit and simulation model.Setting Multiple UK National Health Service (NHS) ophthalmology centres.Participants Data on the reduction in new nAMD referrals were obtained from four NHS Trusts comparing April 2020 with April 2019. To estimate the potential impact on 1-year visual outcomes, a stratified bootstrap simulation model was developed drawing on an electronic medical records dataset of 20 825 nAMD eyes from 27 NHS Trusts.Main outcome measures Simulated mean visual acuity and proportions of eyes with vision ≤6/60, ≤6/24 and ≥6/12 at 1 year under four hypothetical scenarios: 0-month, 3-month, 6-month and 9-month treatment delays. Estimated additional number of eyes with vision ≤6/60 at 1 year nationally.Results The number of nAMD referrals dropped on average by 72% (range 65%–87%). Simulated 1-year visual outcomes for 1000 nAMD eyes with a 3-month treatment delay suggested an increase in the proportion of eyes with vision ≤6/60 from 15.5% (13.2%–17.9%) to 23.3% (20.7%–25.9%), and a decrease in the proportion of eyes with vision ≥6/12 (driving vision) from 35.1% (32.1%–38.1%) to 26.4% (23.8%–29.2%). Outcomes worsened incrementally with longer modelled delays. Assuming nAMD referrals are reduced to this level for 1 month nationally, these simulated results suggest an additional 186–365 eyes with vision ≤6/60 at 1 year.Conclusions We report a large decrease in nAMD referrals during the COVID-19 lockdown and provide an important public health message regarding the risk of delayed treatment. As a conservative estimate, a treatment delay of 3 months could lead to a >50% relative increase in the number of eyes with vision ≤6/60 and 25% relative decrease in the number of eyes with driving vision at 1 year.
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- 2022
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4. Diabetic macular oedema and diode subthreshold micropulse laser (DIAMONDS): study protocol for a randomised controlled trial
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Noemi Lois, Evie Gardner, Norman Waugh, Augusto Azuara-Blanco, Hema Mistry, Danny McAuley, Nachiketa Acharya, Tariq M. Aslam, Clare Bailey, Victor Chong, Louise Downey, Haralabos Eleftheriadis, Samia Fatum, Sheena George, Faruque Ghanchi, Markus Groppe, Robin Hamilton, Geeta Menon, Ahmed Saad, Sobha Sivaprasad, Marianne Shiew, David H. Steel, James Stephen Talks, Catherine Adams, Christina Campbell, Matthew Mills, Mike Clarke, and On behalf of the DIAMONDS Study Group
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Diabetes ,Oedema ,Edema ,DMO ,DME ,Laser ,Medicine (General) ,R5-920 - Abstract
Abstract Background In the UK, macular laser is the treatment of choice for people with diabetic macular oedema with central retinal subfield thickness (CST)
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- 2019
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5. Diabetic Macular Edema and Diode Subthreshold Micropulse Laser
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Noemi Lois, Christina Campbell, Norman Waugh, Augusto Azuara-Blanco, Mandy Maredza, Hema Mistry, Danny McAuley, Nachiketa Acharya, Tariq M. Aslam, Clare Bailey, Victor Chong, Louise Downey, Haralabos Eleftheriadis, Samia Fatum, Sheena George, Faruque Ghanchi, Markus Groppe, Robin Hamilton, Geeta Menon, Ahmed Saad, Sobha Sivaprasad, Marianne Shiew, David H. Steel, James Stephen Talks, Paul Doherty, Cliona McDowell, and Mike Clarke
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Ophthalmology - Published
- 2023
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6. Evolving Treatment Patterns and Outcomes of Neovascular Age-Related Macular Degeneration Over a Decade
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Bobby Paul, Maria Pikoula, A. K. Patwardhan, Abraham Olvera-Barrios, Andrew J. Lotery, A Davis, Vineeth Kumar, Salim Natha, Toks Akerele, Carolyn J.P. Jones, Usha Chakravarthy, Paul Taylor, Roy Schwartz, Haralabos Eleftheriadis, Sudeshna Patra, Christopher Brand, Peck-Lin Lip, Richard J Antcliff, Aaron Y. Lee, Alasdair Warwick, Geeta Menon, Faruque Ghanchi, U. Chakravarthy, Clare Bailey, Elizabeth Wilkinson, Sajjad Mahmood, Louise Downey, Raj Mukherjee, Catherine A Egan, Spiros Denaxas, James S Talks, Peck Lin Lip, Aires Lobo, Rehna Khan, Narendra Dhingra, Sheena George, Helen Palmer, and Adnan Tufail
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Male ,Vascular Endothelial Growth Factor A ,medicine.medical_specialty ,Pediatrics ,Time Factors ,Younger age ,Visual acuity ,Fundus Oculi ,Recombinant Fusion Proteins ,Visual Acuity ,Angiogenesis Inhibitors ,Article ,03 medical and health sciences ,0302 clinical medicine ,Ranibizumab ,Ophthalmology ,Age related ,medicine ,Electronic Health Records ,Humans ,Macula Lutea ,National level ,Fluorescein Angiography ,Retrospective Studies ,030304 developmental biology ,Aflibercept ,0303 health sciences ,business.industry ,Middle Aged ,Macular degeneration ,National health service ,medicine.disease ,Receptors, Vascular Endothelial Growth Factor ,Treatment Outcome ,Intravitreal Injections ,Wet Macular Degeneration ,030221 ophthalmology & optometry ,Female ,medicine.symptom ,business ,Follow-Up Studies ,medicine.drug - Abstract
PURPOSE: Management of neovascular age-related macular degeneration (nAMD) has evolved over the last decade with several treatment regimens and different medications. This study describes the treatment patterns and, importantly, visual outcomes over ten years in a large cohort of patients. DESIGN: Retrospective analysis of electronic health records from 27 National Health Service (NHS) secondary care healthcare providers in the UK. PARTICIPANTS: Treatment-naïve patients receiving at least three intravitreal anti-vascular endothelial growth factor (VEGF) injections for nAMD in their first six months of follow-up were included. Patients with missing data for age or gender and those aged less than 55 were excluded. METHODS: Eyes with at least three years of follow-up were grouped by years of treatment initiation, and three-year outcomes were compared between the groups. Data were generated during routine clinical care between 09/2008 and 12/2018. MAIN OUTCOME MEASURES: Visual acuity, number of injections, number of visits. RESULTS: A total of 15,810 eyes of 13,705 patients receiving 194,904 injections were included. Visual acuity (VA) improved from baseline during the first year, but dropped thereafter, resulting in loss of visual gains. This trend remained consistent throughout the past decade. Although an increasing proportion of eyes remained in the driving standard, this was driven by better presenting visual acuities over the decade. The number of injections dropped substantially between the first and subsequent years, from a mean of 6.25 in year 1 to 3 in year 2 and 2.5 in year 3, without improvement over the decade. In a multivariable regression analysis, final VA improved by 0.24 letters for each year since 2008, and younger age and baseline VA were significantly associated with VA at three years. CONCLUSION: Our findings show that despite improvement in functional VA over the years, primarily driven by improving baseline VA, patients continue to lose vision after the first year of treatment, with only marginal change over the past decade. The data suggest that these results may be related to suboptimal treatment patterns, which have not improved over the years. Rethinking treatment strategies may be warranted, possibly on a national level or through the introduction of longer-acting therapies.
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- 2021
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7. Evaluation of a New Model of Care for People with Complications of Diabetic Retinopathy
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Noemi Lois, Jonathan A. Cook, Ariel Wang, Stephen Aldington, Hema Mistry, Mandy Maredza, Danny McAuley, Tariq Aslam, Clare Bailey, Victor Chong, Faruque Ganchi, Peter Scanlon, Sobha Sivaprasad, David H. Steel, Caroline Styles, Augusto Azuara-Blanco, Lindsay Prior, Norman Waugh, Ahmed Saad, Daniela Vaideanu-Collins, Christine McNally, Andrew Jackson, Rachael Rice, Clair Barbour, Leontia Bell, Faruque D. Ghanchi, Zeid Madanat, Geeta Menon, Manju Chandran, Sely Mathews, Mohammed Galal, Haralabos Eleftheriadis, Stefanos Efraimidis, Jonathan Cook, William Sones, Nachiketa Acharya, Samia Fatum, Janette Savage, Peter H. Scanlon, Katerina Ivanova, Tariq M. Aslam, and Zaria Ali
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Male ,PPI, patient and public involvement ,DME, diabetic macular edema ,Allied Health Personnel ,SD, spectral-domain ,Fundus (eye) ,Multimodal Imaging ,Prospective Studies ,Ophthalmic graders ,UWF, ultra-widefield ,Ophthalmologists ,Follow-up ,Diabetes ,Standard of Care ,Health Care Costs ,Diabetic retinopathy ,Middle Aged ,VEGF, vascular endothelial growth factor ,Critical Pathways ,Spectral-domain OCT ,Female ,Original Article ,EMERALD, Effectiveness of Multimodal Imaging for the Evaluation of Retinal Oedema and New Vessels in Diabetic Retinopathy ,Early Treatment Diabetic Retinopathy Study ,Tomography, Optical Coherence ,Retinopathy ,Adult ,medicine.medical_specialty ,Adolescent ,7-Field ETDRS images ,PDR, proliferative diabetic retinopathy ,ETDRS, Early Treatment Diabetic Retinopathy Study ,NHS, National Health Service ,PRP, panretinal photocoagulation ,Sensitivity and Specificity ,Macular Edema ,Young Adult ,Ophthalmic photographers ,PDR ,Internal medicine ,Diabetes mellitus ,medicine ,DME ,Humans ,In patient ,Ultra-widefield images ,Multimodal imaging ,Diabetic Retinopathy ,business.industry ,Diabetes prevalence ,medicine.disease ,Confidence interval ,eye diseases ,CI, confidence interval ,Ophthalmology ,Cross-Sectional Studies ,Diabetes Mellitus, Type 1 ,Diabetes Mellitus, Type 2 ,business ,Delivery of Health Care ,Pathway - Abstract
Purpose The increasing diabetes prevalence and advent of new treatments for its major visual-threatening complications (diabetic macular edema [DME] and proliferative diabetic retinopathy [PDR]), which require frequent life-long follow-up, have increased hospital demands markedly. Subsequent delays in patient's evaluation and treatment are causing sight loss. Strategies to increase capacity are needed urgently. The retinopathy (EMERALD) study tested diagnostic accuracy, acceptability, and costs of a new health care pathway for people with previously treated DME or PDR. Design Prospective, multicenter, case-referent, cross-sectional, diagnostic accuracy study undertaken in 13 hospitals in the United Kingdom. Participants Adults with type 1 or 2 diabetes previously successfully treated DME or PDR who, at the time of enrollment, had active or inactive disease. Methods A new health care pathway entailing multimodal imaging (spectral-domain OCT for DME, and 7-field Early Treatment Diabetic Retinopathy Study [ETDRS] and ultra-widefield [UWF] fundus images for PDR) interpreted by trained nonmedical staff (ophthalmic graders) to detect reactivation of disease was compared with the current standard care (face-to-face examination by ophthalmologists). Main Outcome Measures Primary outcome: sensitivity of the new pathway. Secondary outcomes: specificity; agreement between pathways; costs; acceptability; proportions requiring subsequent ophthalmologist assessment, unable to undergo imaging, and with inadequate images or indeterminate findings. Results The new pathway showed sensitivity of 97% (95% confidence interval [CI], 92%–99%) and specificity of 31% (95% CI, 23%–40%) to detect DME. For PDR, sensitivity and specificity using 7-field ETDRS images (85% [95% CI, 77%–91%] and 48% [95% CI, 41%–56%], respectively) or UWF images (83% [95% CI, 75%–89%] and 54% [95% CI, 46%–61%], respectively) were comparable. For detection of high-risk PDR, sensitivity and specificity were higher when using UWF images (87% [95% CI, 78%–93%] and 49% [95% CI, 42%–56%], respectively, for UWF versus 80% [95% CI, 69–88%] and 40% [95% CI, 34%–47%], respectively, for 7-field ETDRS images). Participants preferred ophthalmologists’ assessments; in their absence, they preferred immediate feedback by graders, maintaining periodic ophthalmologist evaluations. When compared with the current standard of care, the new pathway could save £1390 per 100 DME visits and between £461 and £1189 per 100 PDR visits. Conclusions The new pathway has acceptable sensitivity and would release resources. Users’ suggestions should guide implementation.
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- 2021
8. Randomised trial of wide-field guided PRP for diabetic macular oedema treated with ranibizumab
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Louise Downey, S James Talks, Sobha Sivaprasad, Haralabos Eleftheriadis, Ngai Victor Chong, Abosede Cole, Geeta Menon, and Devangna Bhatia
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Adult ,Male ,Vascular Endothelial Growth Factor A ,medicine.medical_specialty ,Visual acuity ,genetic structures ,Fundus Oculi ,Visual Acuity ,Angiogenesis Inhibitors ,Article ,Macular Edema ,law.invention ,Young Adult ,Diabetes complications ,Randomized controlled trial ,law ,Ranibizumab ,Ophthalmology ,medicine ,Humans ,Macula Lutea ,Fluorescein Angiography ,Eye diseases ,Aged ,Retrospective Studies ,Aged, 80 and over ,Diabetic Retinopathy ,Laser Coagulation ,Dose-Response Relationship, Drug ,medicine.diagnostic_test ,business.industry ,Retrospective cohort study ,Middle Aged ,Fluorescein angiography ,Wide field ,Peripheral ,Treatment Outcome ,Diabetic macular oedema ,Outcomes research ,Intravitreal Injections ,Female ,medicine.symptom ,business ,Tomography, Optical Coherence ,Follow-Up Studies ,medicine.drug - Abstract
Background: Diabetic macular oedema (DMO) is effectively treated with ranibizumab but multiple injections are required. Where there is also peripheral ischaemia, it has been promoted that targeted panretinal photocoagulation (PRP) may reduce the number of injections. Method: Patients with optical coherence tomography confirmed DMO and Ultra-widefield Fundus Fluorescein Angiography confirmed peripheral retinal ischaemia were randomised to PRP plus ranibizumab or ranibizumab monotherapy. After three injections, repeat injections were given until the visual acuity was stable and the macula was dry. Re-treatment was given if there was a drop of visual acuity and/or a recurrence of intra-retinal fluid. The primary outcome was the number of repeat injections required after the first 6 months up until 1 year. Results: There were 49 patients, 25 in the ranibizumab only group and 24 in the ranibizumab + PRP group recruited at seven UK sites. The average number of injections in the ranibizumab-only arm was 6.84 over 1 year and 2.52 between months 6 and 12. The average number of injections in the combined arm was 6.67, with the number of injections in the second 6 months 1.92. For the primary outcome, comparing the number of 6- to 12-month injections, the result was not statistically significant (p = 0.33). Conclusion: The addition of targeted PRP to areas of non-perfusion in a patient with DMO does not reduce the number of injections required in the first year. It seems most likely that local VEGF at the macula is the main cause of DMO.
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- 2019
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9. Estimating excess visual loss from neovascular age-related macular degeneration in the UK during the COVID-19 pandemic: a retrospective clinical audit and simulation model
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Darren S, Thomas, Alasdair, Warwick, Abraham, Olvera-Barrios, Catherine, Egan, Roy, Schwartz, Sudeshna, Patra, Haralabos, Eleftheriadis, Anthony, Khawaja, Andrew, Lotery, Philipp L, Muller, Robin, Hamilton, Ella, Preston, Paul, Taylor, Adnan, Tufail, and E, Wilkinson
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Clinical Audit ,genetic structures ,Vision Disorders ,COVID-19 ,Angiogenesis Inhibitors ,General Medicine ,State Medicine ,United Kingdom ,eye diseases ,Macular Degeneration ,Treatment Outcome ,Ranibizumab ,Communicable Disease Control ,Intravitreal Injections ,Wet Macular Degeneration ,Humans ,Pandemics ,Retrospective Studies - Abstract
ObjectivesTo report the reduction in new neovascular age-related macular degeneration (nAMD) referrals during the COVID-19 pandemic and estimate the impact of delayed treatment on visual outcomes at 1 year.DesignRetrospective clinical audit and simulation model.SettingMultiple UK National Health Service (NHS) ophthalmology centres.ParticipantsData on the reduction in new nAMD referrals were obtained from four NHS Trusts comparing April 2020 with April 2019. To estimate the potential impact on 1-year visual outcomes, a stratified bootstrap simulation model was developed drawing on an electronic medical records dataset of 20 825 nAMD eyes from 27 NHS Trusts.Main outcome measuresSimulated mean visual acuity and proportions of eyes with vision ≤6/60, ≤6/24 and ≥6/12 at 1 year under four hypothetical scenarios: 0-month, 3-month, 6-month and 9-month treatment delays. Estimated additional number of eyes with vision ≤6/60 at 1 year nationally.ResultsThe number of nAMD referrals dropped on average by 72% (range 65%–87%). Simulated 1-year visual outcomes for 1000 nAMD eyes with a 3-month treatment delay suggested an increase in the proportion of eyes with vision ≤6/60 from 15.5% (13.2%–17.9%) to 23.3% (20.7%–25.9%), and a decrease in the proportion of eyes with vision ≥6/12 (driving vision) from 35.1% (32.1%–38.1%) to 26.4% (23.8%–29.2%). Outcomes worsened incrementally with longer modelled delays. Assuming nAMD referrals are reduced to this level for 1 month nationally, these simulated results suggest an additional 186–365 eyes with vision ≤6/60 at 1 year.ConclusionsWe report a large decrease in nAMD referrals during the COVID-19 lockdown and provide an important public health message regarding the risk of delayed treatment. As a conservative estimate, a treatment delay of 3 months could lead to a >50% relative increase in the number of eyes with vision ≤6/60 and 25% relative decrease in the number of eyes with driving vision at 1 year.
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- 2022
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10. Reply
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Noemi Lois, Ahmed Saad, Daniela Vaideanu-Collins, Augusto Azuara-Blanco, Caroline Styles, Christine McNally, Andrew Jackson, Rachael Rice, Clare Bailey, Danny McAuley, David H. Steel, Clair Barbour, Leontia Bell, Faruque D. Ghanchi, Zeid Madanat, Geeta Menon, Manju Chandran, Sely Mathews, Mohammed Galal, Haralabos Eleftheriadis, Stefanos Efraimidis, Jonathan Cook, Ariel Wang, William Sones, Lindsay Prior, Nachiketa Acharya, Norman Waugh, Hema Mistry, Mandy Maredza, Samia Fatum, Janette Savage, Sobha Sivaprasad, Stephen Aldington, Peter H. Scanlon, Katerina Ivanova, Tariq M. Aslam, Zaria Ali, and Victor Chong
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Ophthalmology - Published
- 2021
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11. Estimating excess visual loss in people with neovascular age-related macular degeneration during the COVID-19 pandemic
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Sudeshna Patra, Catherine A Egan, Darren S. Thomas, Abraham Olvera-Barrios, Haralabos Eleftheriadis, Anthony P Khawaja, Andrew J. Lotery, Ella Preston, Alasdair Warwick, Paul Taylor, Roy Schwartz, Robin Hamilton, Adnan Tufail, and Philipp L. Mueller
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Clinical audit ,Visual acuity ,Coronavirus disease 2019 (COVID-19) ,genetic structures ,business.industry ,Medical record ,Macular degeneration ,medicine.disease ,eye diseases ,Age related ,Pandemic ,medicine ,Optometry ,National level ,medicine.symptom ,business - Abstract
ObjectivesTo report the reduction in new neovascular age-related macular degeneration (nAMD) referrals during the COVID-19 pandemic and estimate the impact of delayed treatment on visual outcomes at one year.DesignRetrospective clinical audit and simulation model.SettingMultiple UK NHS ophthalmology centres.ParticipantsData on the reduction in new nAMD referrals was obtained from four NHS Trusts in England comparing April 2020 to April 2019. To estimate the potential impact on one-year visual outcomes, a stratified bootstrap simulation model was developed drawing on an electronic medical records dataset of 20,825 nAMD eyes from 27 NHS Trusts.Main outcome measuresSimulated mean visual acuity and proportions of eyes with vision ≤6/60, ≤6/24 and ≥6/12 at one year under four hypothetical scenarios: no treatment delay, 3, 6 and 9-month treatment delays. Estimated additional number of eyes with vision ≤6/60 at one year nationally.ResultsThe number of nAMD referrals at four major eye treatment hospital groups based in England dropped on average by 72% (range 65 to 87%) in April 2020 compared to April 2019. Simulated one-year visual outcomes for 1000 nAMD eyes with a 3-month treatment delay suggested an increase in the proportion of eyes with vision ≤6/60 from 15.5% (13.2 to 17.9) to 23.3% (20.7 to25.9), and a decrease in the proportion of eyes with vision ≥6/12 (driving vision) from 35.1% (32.1 to 38.1) to 26.4% (23.8 to29.2). Outcomes worsened incrementally with longer modelled delays. Assuming nAMD referrals are reduced to this level at the national level for only one month, these simulated results suggest an additional 186-365 eyes with vision ≤6/60 at one-year with even a short treatment delay.ConclusionsWe report a large decrease in nAMD referrals during the first month of COVID-19 lockdown and provide an important public health message regarding the risk of delayed treatment. As a conservative estimate, a treatment delay of 3 months could lead to a >50% relative increase in the number of eyes with vision ≤6/60 and 25% relative decrease in the number of eyes with driving vision at one year.
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- 2020
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12. Multimodal Imaging in a Case of Peripapillary Choroidal Neovascular Membrane Associated With Idiopathic Intracranial Hypertension
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Stefanos Eframidis, Haralabos Eleftheriadis, Chinedu N. Igwe, Eoin O'Sullivan, and Paul Nderitu
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medicine.medical_specialty ,Noninvasive imaging ,genetic structures ,Adolescent ,Optic Disk ,Blindness ,Multimodal Imaging ,03 medical and health sciences ,0302 clinical medicine ,Ophthalmology ,Medicine ,Humans ,Multimodal imaging ,Retina ,Pseudotumor Cerebri ,business.industry ,Headache ,Optical coherence tomography angiography ,eye diseases ,Choroidal Neovascularization ,Peripapillary choroidal neovascular membrane ,medicine.anatomical_structure ,030221 ophthalmology & optometry ,Female ,sense organs ,Neurology (clinical) ,Choroid ,Ranibizumab ,business ,030217 neurology & neurosurgery ,Tomography, Optical Coherence ,medicine.drug - Abstract
Optical coherence tomography angiography is one of the latest noninvasive imaging modalities for visualizing the vasculature of retina and choroid. We describe its application in the diagnosis, treatment, and monitoring of a patient with peripapillary choroidal neovascular membrane in the setting of idiopathic intracranial hypertension, who responded well to a course of ranibizumab intravitreal injections.
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- 2020
13. Ranibizumab Plus Panretinal Photocoagulation versus Panretinal Photocoagulation Alone for High-Risk Proliferative Diabetic Retinopathy (PROTEUS Study)
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Sarah Ayello Scheer, Emily Fletcher, Dalila Alves, Conceição Lobo, Catherine Creuzot-Garcher, Rufino Silva, João Figueira, Haralabos Eleftheriadis, João Nascimento, Miguel Amaro, Sandrina Nunes, Monica Varano, Pascale Massin, Geeta Menon, Francesco Bandello, Sobha Sivaprasad, José Cunha-Vaz, Edoardo Midena, Association for Innovation and Biomedical Research on Light and Image (AIBILI), Gloucestershire Hospitals, Partenaires INRAE, Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Universita Vita Salute San Raffaele = Vita-Salute San Raffaele University [Milan, Italie] (UniSR), Universita di Padova, IRCCS, King's Health Partners, Frimley Park Hospital NHS Foundation Trust, Hospital Vila Franca de Xira, Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts (CHNO), Centre des Sciences du Goût et de l'Alimentation [Dijon] (CSGA), Centre National de la Recherche Scientifique (CNRS)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Institut National de la Recherche Agronomique (INRA)-Université de Bourgogne (UB), Department of Ophthalmology, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Instituto de Retina e Diabetes Ocular de Lisboa, Novartis, Bayer, Allergan, Roche, EVICR, Thea, Horus, Novartis Pharma AG., Figueira, João, Fletcher, Emily, Massin, Pascale, Silva, Rufino, Bandello, Francesco, Midena, Edoardo, Varano, Monica, Sivaprasad, Sobha, Eleftheriadis, Haralabo, Menon, Geeta, Amaro, Miguel, Ayello Scheer, Sarah, Creuzot-Garcher, Catherine, Nascimento, João, Alves, Dalila, Nunes, Sandrina, Lobo, Conceição, and Cunha-Vaz, José
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Male ,Vascular Endothelial Growth Factor A ,Visual acuity ,medicine.medical_treatment ,Visual Acuity ,Angiogenesis Inhibitors ,Vitrectomy ,Retinal Neovascularization ,law.invention ,chemistry.chemical_compound ,0302 clinical medicine ,Randomized controlled trial ,law ,Prospective Studies ,Fluorescein Angiography ,Prospective cohort study ,Tomography ,Laser Coagulation ,Diabetic retinopathy ,Middle Aged ,Combined Modality Therapy ,3. Good health ,Intravitreal Injections ,Retreatment ,Female ,medicine.symptom ,Tomography, Optical Coherence ,medicine.drug ,Adult ,medicine.medical_specialty ,03 medical and health sciences ,Ranibizumab ,Ophthalmology ,medicine ,Humans ,[SDV.MHEP.OS]Life Sciences [q-bio]/Human health and pathology/Sensory Organs ,Aged ,Diabetic Retinopathy ,business.industry ,medicine.disease ,chemistry ,Optical Coherence ,Vitreous hemorrhage ,030221 ophthalmology & optometry ,Glycated hemoglobin ,business ,[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology ,030217 neurology & neurosurgery - Abstract
Supplemental material available at www.aaojournal.org.; International audience; PURPOSE: Comparison of the efficacy of ranibizumab (RBZ) 0.5 mg intravitreal injections plus panretinal photocoagulation (PRP) versus PRP alone in the regression of the neovascularization (NV) area in subjects with high-risk proliferative diabetic retinopathy (HR-PDR) over a 12-month period. DESIGN: Prospective, randomized, multicenter, open-label, phase II/III study. PARTICIPANTS: Eighty-seven participants (aged >/=18 years) with type 1/2 diabetes and HR-PDR (mean age, 55.2 years; 37% were female). METHODS: Participants were randomized (1:1) to receive RBZ+PRP (n = 41) or PRP monotherapy (n = 46). The RBZ+PRP group received 3 monthly RBZ injections along with standard PRP. The PRP monotherapy group received standard PRP between day 1 and month 2; thereafter, re-treatments in both groups were at the investigators' discretion. MAIN OUTCOME MEASURES: The primary outcome was regression of NV total, on the disc (NVD) plus elsewhere (NVE), defined as any decrease in the area of NV from the baseline to month 12. Secondary outcomes included best-corrected visual acuity (BCVA) changes from baseline to month 12, time to complete NV regression, recurrence of NV, macular retinal thickness changes from baseline to month 12, need for treatment for diabetic macular edema, need for vitrectomy because of occurrence of vitreous hemorrhage, tractional retinal detachment or other complications of DR, and adverse events (AEs) related to treatments. RESULTS: Seventy-seven participants (88.5%) completed the study. Overall baseline demographics were similar for both groups, except for age. At month 12, 92.7% of participants in the RBZ+PRP group presented NV total reduction versus 70.5% of the PRP monotherapy participants (P = 0.009). The number of participants with NVD and NVE reductions was higher with RBZ+PRP (93.3% and 91.4%, respectively) versus PRP (68.8% and 73.7%, respectively), significant only for NVE (P = 0.048). Complete NV total regression was observed in 43.9% in the RBZ+PRP group versus 25.0% in the PRP monotherapy group (P = 0.066). At month 12, the mean BCVA was 75.2 letters (20/32) in the RBZ+PRP group versus 69.2 letters (20/40) in the PRP monotherapy group (P = 0.104). In the RBZ+PRP group, the mean number of PRP treatments over month 12 was 3.5+/-1.3, whereas in the PRP monotherapy group, it was 4.6+/-1.5 (P = 0.001). No deaths or unexpected AEs were reported. CONCLUSIONS: Treatment with RBZ+PRP was more effective than PRP monotherapy for NV regression in HR-PDR participants over 12 months.
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- 2018
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14. Eplerenone for chronic central serous chorioretinopathy in patients with active, previously untreated disease for more than 4 months (VICI): a randomised, double-blind, placebo-controlled trial
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Mohammed Alarbi, Raj Mukherjee, Steven Dodds, Usha Chakravarthy, Chris A Rogers, Niro Narendran, Ivy Samuel, Edward Hughes, Savita Madhusudhan, Archana Airody, Nicola Hawes, Susan M. Downes, Abigail Raguro, Julie Cloake, Haralabos Eleftheriadis, Mania Horani, Raisa-Marie Platt, Rosie A Harris, Geeta Menon, P. M. Lenfestey, Deepthy Menon, Jeanette Allison, Abby O’Connell, Qin Neville, Sobha Sivaprasad, Niral Karia, Salwa Abugreen, Catrin Watkins, Yit Yang, Joanne A. P. Wilson, Ajay Kotagiri, Karen Gillvray, Wei Sing Lim, Barnaby C Reeves, Francine Behar-Cohen, David H. W. Steel, Maria Edwards, Devanga Bhatia, Clare Bailey, Chris Brand, Ramandeep Chhabra, Manju Chandran, Rebecca Denham, Daniel Buttress, Martin McKibbin, Faruque Ghanchi, Natalie Nixon, Campbell Keir, James S Talks, Krystian Kisza, Sergio Pagliarini, Meena Karpoor, Yinka Osoba, Lucy Culliford, Stephen Turner, Kelly Haigh, Alison Grice-Holt, Angela J. Cree, Elridge Thompson, Violet Andrews, Suresh Thulasidharan, Stefanos Efraimidis, Rebecca Kaye, Richard Gale, Tunde Peto, Helen Griffiths, Sharon Criddle, Phillippa Hazlewood, Lucy Ellis, Linzi Randle, Zeid Madanat, Moin Mohamed, Maria Shipman, Simon P. Harding, Andrew J. Lotery, and Samir Bellani
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Adult ,Male ,medicine.medical_specialty ,Visual acuity ,Population ,Placebo-controlled study ,Visual Acuity ,030204 cardiovascular system & hematology ,Placebo ,BTC (Bristol Trials Centre) ,law.invention ,Medication Adherence ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,Randomized controlled trial ,Double-Blind Method ,law ,Internal medicine ,Correspondence ,Medicine ,Humans ,030212 general & internal medicine ,Young adult ,Adverse effect ,education ,Mineralocorticoid Receptor Antagonists ,education.field_of_study ,business.industry ,General Medicine ,Middle Aged ,Eplerenone ,Treatment Outcome ,Central Serous Chorioretinopathy ,Chronic Disease ,Female ,medicine.symptom ,business ,medicine.drug ,Follow-Up Studies - Abstract
BackgroundIn chronic central serous chorioretinopathy (CSCR), fluid accumulates in the subretinal space. CSCR is a common visually disabling condition that develops in individuals up to 60 years of age, and there is no definitive treatment. Previous research suggests the mineralocorticoid receptor antagonist, eplerenone, is effective for treating CSCR; however, this drug is not licensed for the treatment of patients with CSCR. We aimed to evaluate whether eplerenone was superior to placebo in terms of improving visual acuity in patients with chronic CSCR.MethodsThis randomised, double-blind, parallel-group, multicentre placebo-controlled trial was done at 22 hospitals in the UK. Participants were eligible if they were aged 18–60 years and had had treatment-naive CSCR for 4 months or more. Patients were randomly assigned (1:1) to either the eplerenone or the placebo group by a trial statistician through a password-protected system online. Allocation was stratified by best-corrected visual acuity (BCVA) and hospital. Patients were given either oral eplerenone (25 mg/day for 1 week, increasing to 50 mg/day for up to 12 months) plus usual care or placebo plus usual care for up to 12 months. All participants, care teams, outcome assessors, pharmacists, and members of the trial management group were masked to the treatment allocation. The primary outcome was BCVA, measured as letters read, at 12 months. All outcomes apart from safety were analysed on a modified intention-to-treat basis (participants who withdrew consent without contributing a post-randomisation BCVA measurement were excluded from the primary analysis population and from most secondary analysis populations). The trial is registered with ISRCTN, ISRCTN92746680, and is completed.FindingsBetween Jan 11, 2017, and Feb 22, 2018, we enrolled and randomly assigned 114 patients to receive either eplerenone (n=57) or placebo (n=57). Three participants in the placebo group withdrew consent without contributing a post-randomisation BCVA measurement and were excluded from the primary outcome analysis population. All patients from the eplerenone group and 54 patients from the placebo group were included in the primary outcome. Modelled mean BCVA at 12 months was 79·5 letters (SD 4·5) in the placebo group and 80·4 letters (4·6) in the eplerenone group, with an adjusted estimated mean difference of 1·73 letters (95% CI −1·12 to 4·57; p=0·24) at 12 months. Hyperkalaemia occurred in eight (14%) patients in each group. No serious adverse events were reported in the eplerenone group and three unrelated serious adverse events were reported in the placebo group (myocardial infarction [anticipated], diverticulitis [unanticipated], and metabolic surgery [unanticipated]).InterpretationEplerenone was not superior to placebo for improving BCVA in people with chronic CSCR after 12 months of treatment. Ophthalmologists who currently prescribe eplerenone for CSCR should discontinue this practice.FundingEfficacy and Mechanism Evaluation Programme, and National Institute for Health Research and Social Care.
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- 2019
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15. Anatomical and functional outcomes following switching from aflibercept to ranibizumab in neovascular age-related macular degeneration in Europe: SAFARI study
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David Gilmour, Ian Pearce, Deepali Varma, Konstantinos Balaskas, Susan M. Downes, Faruque Ghanchi, Franklin Igwe, Frank G. Holz, Haralabos Eleftheriadis, Nishal Patel, C Santiago, Robin Hamilton, Steffen Schmitz-Valckenberg, Richard Gale, Priya Prakash, Saju Thomas, Andrew J. Lotery, Filis Ayan, Ben J L Burton, Michael Williams, Armin Wolf, Nicole Eter, Rosina H Zakri, Sheena George, and Gavin Walters
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Male ,Vascular Endothelial Growth Factor A ,Visual acuity ,genetic structures ,Visual Acuity ,degeneration ,Angiogenesis Inhibitors ,neovascularisation ,0302 clinical medicine ,Pro re nata ,Germany ,Clinical endpoint ,Single-Blind Method ,Prospective Studies ,Fluorescein Angiography ,Prospective cohort study ,Aflibercept ,Aged, 80 and over ,education.field_of_study ,Drug Substitution ,imaging ,clinical trial ,Middle Aged ,Clinical Science ,Sensory Systems ,Intravitreal Injections ,Female ,medicine.symptom ,medicine.drug ,medicine.medical_specialty ,Recombinant Fusion Proteins ,Population ,Retina ,03 medical and health sciences ,Cellular and Molecular Neuroscience ,SDG 3 - Good Health and Well-being ,Ophthalmology ,Ranibizumab ,medicine ,Humans ,macula ,education ,Aged ,business.industry ,Macular degeneration ,medicine.disease ,Choroidal Neovascularization ,United Kingdom ,Receptors, Vascular Endothelial Growth Factor ,030221 ophthalmology & optometry ,Wet Macular Degeneration ,business ,030217 neurology & neurosurgery ,Follow-Up Studies - Abstract
Background/AimsProspective data on switching anti-vascular endothelial growth factors in patients with neovascular age-related macular degeneration (nAMD) who have previously shown no/partial response are limited. This prospective study assessed the effect of switching from aflibercept to ranibizumab on anatomical and functional outcomes in patients with persistent/recurrent disease activity.MethodsSAFARI (NCT02161575) was a 6-month, prospective, single-arm study conducted in the UK and Germany. Patients, meeting strict eligibility criteria for one of two subgroups (primary treatment failure or suboptimal treatment response), received 3 monthly intravitreal ranibizumab injections (0.5 mg). Thereafter, ranibizumab was administered pro re nata at monthly visits. The primary endpoint was change from baseline (CfB) to day 90 in central subfield retinal thickness (CSRT). Best-corrected visual acuity (BCVA) and retinal morphology parameters were assessed.ResultsOne hundred patients were enrolled (primary treatment failure, 1; suboptimal treatment response, 99). In the overall population, there was a significant CfB in median CSRT of −30.75 µm (95% CI −59.50,–20.50; pConclusionSwitching from aflibercept to ranibizumab led to a significant improvement in CSRT, with ~60% experiencing stabilised/improved BCVA. Therefore, patients with nAMD who have shown a suboptimal response to aflibercept may benefit from switching to ranibizumab.
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- 2019
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16. Additional file 2: of Diabetic macular oedema and diode subthreshold micropulse laser (DIAMONDS): study protocol for a randomised controlled trial
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Lois, Noemi, Gardner, Evie, Waugh, Norman, Azuara-Blanco, Augusto, Mistry, Hema, McAuley, Danny, Nachiketa Acharya, Aslam, Tariq, Bailey, Clare, Chong, Victor, Downey, Louise, Haralabos Eleftheriadis, Fatum, Samia, George, Sheena, Ghanchi, Faruque, Groppe, Markus, Hamilton, Robin, Menon, Geeta, Saad, Ahmed, Sivaprasad, Sobha, Shiew, Marianne, Steel, David, Talks, James, Adams, Catherine, Campbell, Christina, Mills, Matthew, and Clarke, Mike
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Roles and responsibilities of the Trial Steering Committee (TSC) and Data monitoring and Ethics Committee (DMEC). (PDF 434 kb)
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- 2019
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17. Clinical efficacy and safety of a light mask for prevention of dark adaptation in treating and preventing progression of early diabetic macular oedema at 24 months (CLEOPATRA): a multicentre, phase 3, randomised controlled trial
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Randhir Chavan, S J Aldington, Arevik Ghulakhszian, Roxanne Crosby-Nwaobi, Richard D. Smith, Priya Prakash, Edward Hughes, Geoffrey B. Arden, Debendra N. Sahu, Sarah Walker, Alaistair Denniston, Jackie Sturt, Nirodhini Narendran, Nisha Shah, Abosede Cole, Sobha Sivaprasad, Haralabos Eleftheriadis, Joanna Kelly, Peter H Scanlon, Afsar Jafree, Sheena George, Tatiana Mansour, S Chave, A Dale, Tunde Peto, Namritha Patrao, A Toby Prevost, Ajay Bhatnagar, Joana C. Vasconcelos, Philip Hykin, Douglas Lewin, Gary S. Rubin, Chris Hogg, Caroline Murphy, Gilli Vafidis, Maria Sandinha, Frank Ahfat, Geeta Menon, David P. Crabb, Catherine A Egan, Gillian Hood, Joanathan Gibson, Graham A. Hitman, Ian Grierson, Helen Holmes, Deepthy Menon, Lauren Leitch-Devlin, and National Institute for Health Research
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Male ,Endocrinology, Diabetes and Metabolism ,THERAPY ,law.invention ,0302 clinical medicine ,Endocrinology ,Randomized controlled trial ,law ,SCALE ,Sleep disorder ,Diabetic retinopathy ,Middle Aged ,INTENTION ,Editorial ,Treatment Outcome ,Disease Progression ,Female ,Life Sciences & Biomedicine ,Tomography, Optical Coherence ,medicine.medical_specialty ,Dark Adaptation ,Minimisation (clinical trials) ,Article ,Macular Edema ,Retina ,03 medical and health sciences ,Endocrinology & Metabolism ,SDG 3 - Good Health and Well-being ,Ophthalmology ,Internal Medicine ,medicine ,Journal Article ,Humans ,Adverse effect ,Macular edema ,CLEOPATRA Study Group ,Aged ,Science & Technology ,Diabetic Retinopathy ,business.industry ,Phototherapy ,medicine.disease ,Clinical trial ,Diabetic macular oedema ,030221 ophthalmology & optometry ,RE ,business ,030217 neurology & neurosurgery ,RC - Abstract
BACKGROUND: We aimed to assess 24-month outcomes of wearing an organic light-emitting sleep mask as an intervention to treat and prevent progression of non-central diabetic macular oedema.METHODS: CLEOPATRA was a phase 3, single-blind, parallel-group, randomised controlled trial undertaken at 15 ophthalmic centres in the UK. Adults with non-centre-involving diabetic macular oedema were randomly assigned (1:1) to wearing either a light mask during sleep (Noctura 400 Sleep Mask, PolyPhotonix Medical, Sedgefield, UK) or a sham (non-light) mask, for 24 months. Randomisation was by minimisation generated by a central web-based computer system. Outcome assessors were masked technicians and optometrists. The primary outcome was the change in maximum retinal thickness on optical coherence tomography (OCT) at 24 months, analysed using a linear mixed-effects model incorporating 4-monthly measurements and baseline adjustment. Analysis was done using the intention-to-treat principle in all randomised patients with OCT data. Safety was assessed in all patients. This trial is registered with Controlled-Trials.com, number ISRCTN85596558.FINDINGS: Between April 10, 2014, and June 15, 2015, 308 patients were randomly assigned to wearing the light mask (n=155) or a sham mask (n=153). 277 patients (144 assigned the light mask and 133 the sham mask) contributed to the mixed-effects model over time, including 246 patients with OCT data at 24 months. The change in maximum retinal thickness at 24 months did not differ between treatment groups (mean change -9·2 μm [SE 2·5] for the light mask vs -12·9 μm [SE 2·9] for the sham mask; adjusted mean difference -0·65 μm, 95% CI -6·90 to 5·59; p=0·84). Median compliance with wearing the light mask at 24 months was 19·5% (IQR 1·9-51·6). No serious adverse events were related to either mask. The most frequent adverse events related to the assigned treatment were discomfort on the eyes (14 with the light mask vs seven with the sham mask), painful, sticky, or watery eyes (14 vs six), and sleep disturbance (seven vs one).INTERPRETATION: The light mask as used in this study did not confer long-term therapeutic benefit on non-centre-involving diabetic macular oedema and the study does not support its use for this indication.FUNDING: The Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research partnership.
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- 2018
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18. Model for risk-based screening of diabetic retinopathy in people with newly-diagnosed type 2 diabetes mellitus
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Haralabos Eleftheriadis, Khalida Ismail, Sobha Sivaprasad, Kirsty Winkley, Stephanie A. Amiel, Irini Chatziralli, Roxanne Crosby-Nwaobi, and Theodoros N. Sergentanis
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Male ,medicine.medical_specialty ,Population ,030209 endocrinology & metabolism ,03 medical and health sciences ,0302 clinical medicine ,Risk Factors ,Internal medicine ,Diabetes mellitus ,medicine ,Albuminuria ,Humans ,Mass Screening ,education ,Inflammatory ,Aged ,Glycated Hemoglobin ,Univariate analysis ,education.field_of_study ,Diabetic Retinopathy ,medicine.diagnostic_test ,Adiponectin ,Tumor Necrosis Factor-alpha ,business.industry ,Interleukins ,Diabetes ,Type 2 Diabetes Mellitus ,Diabetic retinopathy ,Middle Aged ,Lipid ,medicine.disease ,Lipids ,Logistic Models ,Diabetes Mellitus, Type 2 ,Risk factors ,Cohort ,Immunology ,030221 ophthalmology & optometry ,Female ,Lipid profile ,business ,Biomarkers ,Model - Abstract
Purpose: The purpose of this study was to evaluate the role of inflammatory/lipid markers and potential risk factors for diabetic retinopathy (DR) development in newly diagnosed patients with type 2 diabetes mellitus (T2DM). Methods: Participants in this study were 1062 patients with newly diagnosed T2DM. Demographic and clinical data of patients were collected. Assessment of DR status was performed using digital two-field photography. In addition, HbA1c (%), lipid profile, and urinary albumin were measured at recruitment. The following inflammatory markers were also measured: serum C-reactive protein, white blood cells, platelet, adiponectin, IL-4, IL-6, IL-10, vascular endothelial growth factor, tumor necrosis factor-a (TNF-a), IL-1b, IL-1 receptor antagonist (IL-1RA), and monocyte chemotactic protein-1. Univariate and multivariate analyses of the association of various potential risk factors and DR were conducted.Results: Univariate analysis showed that male sex, any cardiovascular event, and HbA1c were positively associated with DR, while IL-1RA, IL-1b, IL-6, and TNF-a were significantly negatively associated with presence of DR in the cohort. Risk factors that remained significantly associated with DR presence at the multivariate analysis were male sex, any cardiovascular event, HbA1c, and IL-1RA. Conclusions: Our study demonstrated that HbA1c levels, male sex, and previous cardiovascular events were risk factors for presence of DR in people with newly diagnosed T2DM, while IL-1RA seemed to have a protective role. The prevalence of DR in our population was 20.2%, reflecting current practice. Our findings may contribute to future risk-based modelling of screening for DR.
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- 2017
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19. Long-term recovery of the human corneal endothelium after toxic injury by benzalkonium chloride
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Haralabos Eleftheriadis, Marike Pretorius, Christopher Liu, and Ed Hughes
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Male ,medicine.medical_specialty ,Corneal endothelium ,Endothelium ,medicine.medical_treatment ,Scientific Report ,Visual Acuity ,Cell Count ,Corneal Diseases ,Cornea ,Cellular and Molecular Neuroscience ,Ophthalmology ,medicine ,Humans ,Medication Errors ,Decompensation ,Aged ,Aged, 80 and over ,Intraoperative Care ,Phacoemulsification ,medicine.diagnostic_test ,business.industry ,Corneal Edema ,Endothelium, Corneal ,Preservatives, Pharmaceutical ,Corneal Topography ,Middle Aged ,Cataract surgery ,Prognosis ,Corneal topography ,Sensory Systems ,medicine.anatomical_structure ,Toxic injury ,Female ,Benzalkonium Compounds ,business ,Follow-Up Studies - Abstract
Introduction: The inadvertent intra-ocular administration of benzalkonium chloride-preserved hydroxypropyl methylcellulose during cataract surgery at another hospital in 1999 resulted in toxic corneal endothelial injury and profound postoperative corneal oedema as a result of endothelial decompensation. The long-term effect of this adverse event was assessed. Methods: All 19 patients were invited to return for examination including corneal endothelial specular microscopy and pachymetry seven years after the incident. Results were compared with data from one year after the incident. Results: Five patients attended for examination, one had received a penetrating keratoplasty and was, therefore, excluded. Ten patients had died and four had moved out of the region and were unable to attend. All four study patients were pain free and achieved 6/12 or better. Mean central corneal thickness reduced by 13% from 652.6 μm at one year to 563.4 μm. Mean central corneal endothelial cell density (n = 3) increased 28% from 663.7 cells/mm 2 at one year to 835.7 cells/mm 2 (p Conclusions: After toxic injury, corneal endothelial function may have a remarkable capacity for recovery even after the first postoperative year. The rise in central endothelial cell density may represent cell migration from less affected areas or cellular proliferation. Should this unfortunate event recur, clinicians may expect continued recovery beyond one year.
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- 2007
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20. Intravitreal aflibercept (A-IVI) for the treatment of neovascular age-related macular degeneration (nv-AMD): one year experience
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Evangelia Papavasileiou, Zygoura, V., Richardson, T., Cortis, D., Haralabos Eleftheriadis, and Timothy Jackson
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genetic structures ,sense organs ,eye diseases - Abstract
OBJECTIVE: To report the anatomical and functional results of intravitreal injections of aflibercept (Eylea) (A-IVI) for the treatment of naïve eyes with neovascular age-related macular degeneration (nv-AMD). SUBJECTS AND METHODS: This retrospective, one-center, non-comparative chart review included 26 treatment naïve eyes with nv-AMD of 26 patients (14 male) with a mean age of 80.5 (range 63-91) who had a complete follow-up of 14 months. The morphological analysis included spectral domain optical coherence tomography and fundus fluorescein angiography, while the functional assessment included logarithm of the minimum angle of resolution (LogMAR) best correct visual acuity (BCVA). The timing of the follow-up was: baseline, 3, 6, and 14 months. All patients received 8 A-IVI according to the protocol (first 3 consecutive monthly A-IVI, followed by bi-monthly retreatment for the first year, regardless of disease activity as per local guidelines). Statistical analysis was performed using ANOVA. Improvement of visual acuity more than 15 letters was considered as "improvement", less than 5 letters as "stable" and any letter loss as "worsening". RESULTS: Mean±standard deviation LogMAR visual acuity improved from 0.26±0.15 at presentation to 0.14±0.20 at the final follow-up of 14 months (P=0.02). BCVA was stable in 23.1%, improved in 61.5% (16 eyes) worsened in 15.4%. A mean pretreatment central macular thickness of 409μm reduced significantly to 229μm at month 14 (P
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- 2015
21. Interlenticular opacification in piggyback AcrySof intraocular lenses: explantation technique and laboratory investigations
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Haralabos Eleftheriadis, Christopher Liu, George Duncan, and Julia M. Marcantonio
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Male ,Reoperation ,medicine.medical_specialty ,genetic structures ,medicine.medical_treatment ,Intraocular lens ,Interlenticular opacification ,Cataract ,Cellular and Molecular Neuroscience ,Cell Movement ,Humans ,Contact zone ,Medicine ,Treatment Failure ,Lenses, Intraocular ,business.industry ,Epithelium, Corneal ,Capsule ,Epithelial Cells ,Middle Aged ,Original articles - Clinical science ,eye diseases ,Sensory Systems ,Surgery ,Ophthalmology ,Apposition ,Intraocular lenses ,Homogeneous ,Capsular bag ,sense organs ,business ,Cell Division - Abstract
BACKGROUND/AIMS Interlenticular opacification (ILO) is a recognised complication of piggyback intraocular lenses (IOLs). The aetiology, histopathology, and treatment are not clearly defined, however. METHODS Two pairs of AcrySof IOLs were explanted from a patient with bilateral ILO. The explantation technique and surgical challenges of IOL exchanges are described. The explanted IOL complexes and a sample of the anterior capsule were examined by phase, polarising, and immunofluorescence microscopy. RESULTS A 50 year old man developed ILO bilaterally after piggyback AcrySof IOL implantation. A central contact zone was surrounded by a homogeneous paracentral opacity possibly consisting of extracellular matrix previously laid down by proliferating lens epithelial cells (LECs). These opacities were in turn surrounded by interlenticular Elschnig pearl-type opacities contiguous with the same material filling the periphery of the capsular bag. The IOL complexes were very adherent to the capsular bag and they had to be separated with the help of high viscosity viscoelastic before a single one piece PMMA IOL implantation via large limbal incisions. The sample of anterior capsule showed a ridge configuration from the piling of LECs in the site of apposition with the anterior capsule and cells showing different characteristics on either side of the ridge. CONCLUSION Cellular proliferation, deposition of ECM from proliferating LECs, and capsular changes induced by cell metaplasia may lead to ILO formation in piggyback AcrySof IOLs. Careful separation of the AcrySof IOL complex from the capsule, meticulous clean up of the proliferating material, and implantation of single or dual in the bag PMMA IOLs through a large incision with capsulorrhexis enlargement may help in the prevention of recurrence of interface opacification.
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- 2001
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22. Intravitreal aflibercept (A-IVI) for the treatment of neovascular age-related macular degeneration (nv-AMD): one year experience
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Evangelia, Papavasileiou, Vasiliki, Zygoura, Theresa, Richardson, Dominic, Cortis, Haralabos, Eleftheriadis, and Timothy L, Jackson
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To report the anatomical and functional results of intravitreal injections of aflibercept (Eylea) (A-IVI) for the treatment of naïve eyes with neovascular age-related macular degeneration (nv-AMD).This retrospective, one-center, non-comparative chart review included 26 treatment naïve eyes with nv-AMD of 26 patients (14 male) with a mean age of 80.5 (range 63-91) who had a complete follow-up of 14 months. The morphological analysis included spectral domain optical coherence tomography and fundus fluorescein angiography, while the functional assessment included logarithm of the minimum angle of resolution (LogMAR) best correct visual acuity (BCVA). The timing of the follow-up was: baseline, 3, 6, and 14 months. All patients received 8 A-IVI according to the protocol (first 3 consecutive monthly A-IVI, followed by bi-monthly retreatment for the first year, regardless of disease activity as per local guidelines). Statistical analysis was performed using ANOVA. Improvement of visual acuity more than 15 letters was considered as "improvement", less than 5 letters as "stable" and any letter loss as "worsening".Mean±standard deviation LogMAR visual acuity improved from 0.26±0.15 at presentation to 0.14±0.20 at the final follow-up of 14 months (P=0.02). BCVA was stable in 23.1%, improved in 61.5% (16 eyes) worsened in 15.4%. A mean pretreatment central macular thickness of 409μm reduced significantly to 229μm at month 14 (P0.02). The OCT of eyes with worsened BCVA showed resolution of retinal fluid but presence of subretinal fibrosis. No adverse events were attributed to aflibercept.Patients who had a worsening in visual acuity were found to have longer duration of symptoms prior to treatment and presence of geographic atrophy, and/or subretinal haemorrhage and/or subretinal fibrosis at baseline. From our experience, with 14 months follow-up, A-IVI is an effective treatment for treatment naïve patients with nv-AMD. Our real world results were similar to pivotal trials.
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- 2013
23. Real-world treatment of diabetic macular oedema: a comparison of combined ranibizumab plus macular LASER with macular LASER monotherapy
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Vasiliki, Zygoura, Evangelia, Papavasileiou, Demetrios G, Vavvas, Dominic, Cortis, Haralabos, Eleftheriadis, and Timothy L, Jackson
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To study real world outcomes of ranibizumab (Lucentis) intravitreal injection in diabetic macular oedema (DMO).We included 100 patients with DMO. Those who had optical coherence tomography central retinal thickness (CRT) of 400μm or more (Group 1) underwent combination treatment with ranibizumab and macular LASER, while those with CRT less than 400μm (Group 2) had LASER monotherapy. The primary outcome measure was change in best corrected visual acuity (BCVA) from baseline. Secondary outcomes were change of CRT from baseline, the number of intravitreal injections in group one during the first and second year of follow-up and the proportion of LASER sessions in both groups at 2 years follow-up. Patients' lipid profile was compared to the presence and extent of macular hard exudates, quantified using masked readers and image analysis software.Group 1 showed better outcomes in terms of BCVA and CRT compared to Group 2 during the two-year follow-up period. The mean number of ranibizumab intravitreal injections in Group 1 was reduced from 3.86 (standard deviation±1.37) in the first year to 2.02 in the second year. At 2 years, Group 1 had a higher proportion of individuals that had undergone 3 macular LASER treatments (4% Group 1, 28% Group 2). The presence of hard exudates was associated with higher total cholesterol (P=0.004 and P=0.041 group 1 and 2 respectively) and with higher low density lipoprotein (LDL) cholesterol (P=0.01 and P=0.045 respectively). The size of hard exudates was associated with higher total cholesterol (P=0.02 and P=0.03 respectively) and with higher LDL cholesterol (P=0.003 and P=0.01 respectively). Neither high density lipoprotein (HDL) cholesterol, nor triglycerides were related to the presence or size of hard exudates. No serious adverse events were attributed to either LASER or ranibizumab.Combination treatment of intravitreal ranibizumab injections and macular LASER appears safe and effective over two years. The need for injection declines over time. There is an association between higher levels of serum total and LDL cholesterol and the presence and the extent of hard exudates.
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- 2013
24. Primary polypseudophakia for cataract surgery in hypermetropic eyes: refractive results and long term stability of the implants within the capsular bag
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Christopher C. Hull, Haralabos Eleftheriadis, André R Ismail, Christopher Liu, and Andrea Sciscio
- Subjects
Male ,Refractive error ,medicine.medical_specialty ,Visual acuity ,Biometry ,genetic structures ,Eye disease ,medicine.medical_treatment ,Visual Acuity ,Intraocular lens ,Cataract Extraction ,Refraction, Ocular ,Cataract ,Vision disorder ,Cellular and Molecular Neuroscience ,Lens Implantation, Intraocular ,Ophthalmology ,medicine ,Humans ,Prospective Studies ,Aged ,Ultrasonography ,Aged, 80 and over ,business.industry ,Phacoemulsification ,Cataract surgery ,Middle Aged ,medicine.disease ,Original articles - Clinical science ,Sensory Systems ,eye diseases ,Surgery ,Hyperopia ,Treatment Outcome ,Optic nerve ,Female ,sense organs ,medicine.symptom ,business - Abstract
Aim—To determine the long term visual and refractive results, and stability and complications of primary polypseudophakia using poly(methylmethacrylate) (PMMA) intraocular lenses (IOLs) for cataract surgery in hypermetropic eyes. Methods—Prospective study of 15 short or hypermetropic eyes undergoing phacoemulsification with primary polypseudophakia with two PMMA IOLs implanted within the capsular bag. Results—The spherical equivalent was reduced from a mean +4.87 (SD 3.00) dioptres (D) to ˛0.12 (1.40 D), and the deviation from the intended refraction was +0.005 (1.30) D, 23.6 (12.36) months post-implantation. The deviation from intended refraction was not statistically significant (p = 0.989; paired t test). Postoperative best corrected visual acuity (BCVA) was 6/12 or better in all eyes without macular or optic nerve co-morbidity. Interlenticular opacification (ILO) in the form of peripheral Elschnig pearls was seen in four (26.67%) eyes. A new type of ILO in the form of usually pigmented deposits in the central interface developed in five (33.33%) eyes and resulted in the appearance of Newton’s rings in three. None of the eyes with ILO had any loss of BCVA or hyperopic shift. Six (40%) eyes were within 1 D from the intended refraction and 14 (93.33%) within 2 D. There was no statistically significant diVerence in the accuracy of the two intraocular lens calculation formulas used (SRK II and SRK/T). Conclusion—Peripheral Elschnig pearltype ILO can occur as a late complication of primary in the bag implantation of two PMMA IOLs. A new type of ILO is described. Both types of ILO have not to date resulted in deterioration of visual acuity in our cohort. Use of appropriate biometry techniques and IOL calculation formulas may yield more accurate refractive results. (Br J Ophthalmol 2001;85:1198‐1202)
- Published
- 2001
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