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Francesco Oddone,1 Vincenzo Scorcia,2 Michele Iester,3 Dario Sisto,4 Stefano De Cilla,5 Paolo Bettin,6 Carlo Cagini,7 Michele Figus,8 Giorgio Marchini,9 Luca Rossetti,10 Gemma Rossi,11 Tommaso Salgarello,12,13 Gian Luca Scuderi,14 Giovanni Staurenghi15 On behalf of the VISIONARY Study Group (Italy)1Glaucoma Unit, IRCSS-Fondazione Bietti, Roma, Italy; 2Department of Ophthalmology, University Magna Græcia of Catanzaro, Catanzaro, Italy; 3Eye Clinic of Genoa, Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DiNOGMI), University of Genova, Genova, Italy; 4Ophthalmology Department, University of Bari, Bari, Italy; 5Department of Health Sciences, Eye Clinic, University of Piemonte Orientale, Novara, Italy; 6Department of Ophthalmology, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milano, Italy; 7Department of Medicine and Surgery, Ophthalmology Section, University of Perugia, Perugia, Italy; 8Ophthalmology, Department of Surgery, Medicine, Molecular and Emergency, University of Pisa, Pisa, Italy; 9Ophthalmology Unit, Department of Neurosciences, Biomedicine and Movement, University of Verona, Verona, Italy; 10Eye Clinic, San Paolo Hospital, University of Milan, Milano, Italy; 11University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy; 12Ophthalmology Unit, Department of Ageing, Neurosciences, Head-Neck and Orthopaedics Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy; 13Institute of Ophthalmology, Università Cattolica del Sacro Cuore, Roma, Italy; 14NESMOS Department, Ophthalmology Unit, St. Andrea Hospital, Università di Roma La Sapienza, Roma, Italy; 15Eye Clinic, Department of Biomedical and Clinical Sciences Luigi Sacco, University of Milan, Milano, ItalyCorrespondence: Francesco Oddone, Glaucoma Unit, IRCSS-Fondazione Bietti, Roma, Italy, Tel + 39 06 85356727, Email oddonef@gmail.comIntroduction: The VISIONARY study examined the intraocular pressure (IOP)-lowering efficacy and tolerability of the preservative-free fixed-dose combination of tafluprost (0.0015%) and timolol (0.5%) (PF tafluprost/timolol FC) in a real-world setting. The country-level data reported herein comprise the largest and first observational study of PF tafluprost/timolol FC therapy in Italy.Methods: An observational, multicenter, prospective study included adult Italian patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) demonstrating insufficient response or poor tolerability with topical prostaglandin analogue (PGA) or beta-blocker monotherapy. Treatment was switched to PF tafluprost/timolol FC therapy at baseline. Primary endpoint was the absolute mean IOP change from baseline at Month 6. Exploratory and safety endpoints included change in IOP at Weeks 4 and 12, ocular signs, symptom severity and reporting of adverse events (AEs).Results: Overall, 160 OAG/OHT patients were included. Mean ± standard deviation IOP was reduced from 19.6 ± 3.6 mmHg at baseline to 14.5 ± 2.6 mmHg at Month 6 (reduction of 5.1 ± 3.7 mmHg; 24.1%; p < 0.0001). IOP reduction was also statistically significant at Week 4 (23.1%; p < 0.0001) and Week 12 (24.7%; p < 0.0001). Based on data cutoff values for mean IOP change of ≥ 20%, ≥ 25%, ≥ 30% and ≥ 35%, respective Month 6 responder rates were 68.1%, 48.7%, 36.2% and 26.9%. Most ocular signs and symptoms were significantly reduced in severity from baseline at Month 6. Two non-serious and mild AEs were reported during the study period, among which, one AE was treatment-related (eyelash growth). &#x2003Conclusion: Italian OAG and OHT patients demonstrated a significant IOP reduction from baseline at Week 4 that was maintained over a 6-month period following a switch from topical PGA or beta-blocker monotherapy to PF tafluprost/timolol FC therapy. Severity of most ocular signs and symptoms was significantly reduced during the study period, and PF tafluprost/timolol FC was generally well tolerated.Keywords: fixed-dose combination therapy, intraocular pressure, ocular hypertension, PF tafluprost/timolol FC, preservative-free topical medication, primary open-angle glaucoma

Aldo Caporossi,1 Giovanni Alessio,2 Francesco Fasce,3 Giorgio Marchini,4 Antonio Rapisarda,5 Vincenzo Papa6 1Department of Ophthalmology, Policlinico Universitario A. Gemelli IRCSS Università Cattolica del Sacro Cuore, Roma, Italy; 2Ophthalmology Unit, Dipartimento di Scienze mediche di base, Neuroscienze e Organi di Senso Università di Bari, Azienda Ospedaliera Policlinico Consorziale, Bari, Italy; 3Ophthalmology Unit, IRCSS San Raffaele, Milano, Italy; 4Ophthalmology Unit, Ospedale Policlinico G.B. Rossi, Università di Verona, Verona, Italy; 5Ophthalmology Unit, Azienda Ospedaliera Garibaldi, Catania, Italy; 6Medical Affairs SIFI SpA, Catania, ItalyCorrespondence: Vincenzo PapaMedical Affairs SIFI SpA, Via E. Patti 36, Aci S. Antonio, Catania, ItalyEmail vincenzo.papa@sifigroup.comPurpose: To evaluate the short-term anti-inflammatory effect of dexamethasone/netilmicin fixed combination in the management of ocular inflammation after cataract surgery.Patients and Methods: Open-label, randomized, active-controlled, clinical study conducted in 6 sites in Italy; 238 patients were randomized 2:1 to dexamethasone/netilmicin (dexa/net, n=158) or betamethasone/chloramphenicol (beta/chl, n=80). Treatment started the day of surgery and continued 4 times daily for 7 days. The primary efficacy parameter was the anterior chamber (AC) flare. The percentage of patients displaying none or mild (ie, only barely detectable) AC flare was defined as “efficacy rate”, whereas the percentage of patients showing a decrease of AC flare score from baseline was defined as “percentage of responders”. Additional parameters evaluated were AC cells, conjunctival hyperaemia, corneal and lid oedema, symptoms of ocular discomfort, visual acuity, and intraocular pressure. Dexa/net was considered effective if the efficacy rate was not inferior (by means of 97.5% confidence interval) to that of beta/chl.Results: After 7 days of treatment, no AC flare was observed in 92.8% (dexa/net) and 92.3% (beta/chl) of patients, whereas no AC cells were observed in 91.5% (dexa/net) and 93.6% (beta/chl) of patients, respectively. The “efficacy rate” was 100% in both groups, whereas the “percentage of responders” was 94.1% in the dexa/net and 93.6% in the beta/chl group. The p-value to reject the null hypothesis of inferiority was < 0.001. Other efficacy parameters confirmed both treatments as highly effective, despite their difference in steroid content (2 mg/mL for beta/chl vs 1 mg/mL for dexa/net). IOP and visual acuity at the end of the study were comparable. Two cases of allergic conjunctivitis were considered adverse events and were both related to dexa/net.Conclusion: Short-term use of dexa/net fixed combination is safe and effective in the control of post-operative inflammation following uncomplicated cataract surgery.Keywords: cataract surgery, fixed combination, netilmicin, chloramphenicol

Elia Franzolin, Rosa Longo, Stefano Casati, Piero Ceruti, Giorgio Marchini Ophthalmic Unit, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, ItalyCorrespondence: Elia FranzolinOphthalmic Unit, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, P.le L. A. Scuro 10, Verona, 37134, ItalyTel +39 3408245862Email franzolinelia@gmail.comPurpose: To compare the incidence and clinical characteristics of retinal detachments (RDs) diagnosed in a tertiary eye emergency department (EED) during the COVID-19 pandemic and in the corresponding period of the previous 4 years.Methods: EED consultations performed from February 21, 2020 (first national case of COVID-19 infection) to May 3, 2020 (end of lockdown imposed by national Government) and for the same date range of 2016– 2019 (pre-COVID-19 period), and with a confirmed diagnosis of RD were collected and reviewed. The following demographical and clinical features have been analyzed: age, gender, etiology of RD, macular involvement, best corrected visual acuity (BCVA), and duration of experienced symptoms.Results: Eighty-two subjects (20.5± 1.0 eyes/year) were diagnosed with RD in the pre-COVID-19 period, compared to 12 patients in the COVID-19 period (− 41.5%). During the pandemic, patients complained symptoms for a median of 8.5 days (IQR, 1.7– 15 days) before the EED consultation, while in the pre-COVID-19 period, they declared they had been symptomatic for 2 days (IQR, 1– 4 days) (p=0.037); macula-off RD raised from 56% to 75% and no one reported trauma as a triggering event.Conclusion: During the COVID-19 pandemic, the rate of RD diagnosed in our EED decreased significantly and patients waited longer before asking for an ophthalmologic examination. These findings are probably due to the fear of contracting the COVID-19 infection attending hospital environments. Even if emergency departments are often misused by people suffering non-urgent conditions, patients complaining of sudden visual loss, visual field defects, or phosphenes should always and promptly attend an EED visit to prevent a worse prognosis.Keywords: COVID-19 pandemic, eye emergency department, EED, eye, lockdown, retinal detachment, RD

Emilio Pedrotti,1 Erika Bonacci,1 Arianna De Rossi,1 Jacopo Bonetto,1 Chiara Chierego,1 Adriano Fasolo,1,2 Alessandra De Gregorio,3 Giorgio Marchini1 1Ophthalmic Unit, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Policlinico G.B. Rossi, Verona, 37134, Italy; 2Research Unit, The Veneto Eye Bank Foundation, Venezia, 30174, Italy; 3Ophthalmic Unit, San Bassiano Hospital, Bassano Del Grappa, 36061, Vicenza, ItalyCorrespondence: Adriano FasoloThe Veneto Eye Bank Foundation, c/o Pad. G. Rama, via Paccagnella 11, Venice, 30174, ItalyTel +390419656400Fax +390419656401Email adriano.fasolo@yahoo.itPurpose: To determine whether type 1 big-bubble (BB) formation is influenced by the sequence of incisions created with the Victus femtosecond laser (FSL) enabled with software version 3.4 (SV 3.4) during deep anterior lamellar keratoplasty (DALK).Materials and Methods: Consecutive FSL-assisted DALK BB procedures were performed on 20 human donor corneas: 10 shaped by tunnel incision followed by lamellar incision (tunnel-lamellar group, TL) and 10 in the reverse order (lamellar-tunnel group, LT). The BB type was assessed by evaluating dynamic air movement during air inflation; bubble diameter and floor thickness were measured by anterior segment optical coherence tomography.Results: Overall, a type 1 BB formed in 85% of eyes: 100% in the TL group and 70% in the LT group. In the LT group, a type 2 BB formed in 2 corneas and one cornea was perforated during cannula insertion. Type 1 BB was achieved after one attempt in 90% of eyes in the TL group and in 57% in the LT group.Conclusion: Shaping the tunnel before rather than after lamellar incision may be more effective for obtaining a type 1 BB by air injection.Keywords: deep anterior lamellar keratoplasty, femtosecond laser, big bubble, intrastromal incision, lamellar incision

Giorgio Marchini, Marco Toscani, Francesca Chemello Eye Clinic, Department of Neurological and Movement Sciences, University of Verona, Verona, Italy Abstract: “Childhood glaucoma” is a heterogeneous group of severe pediatric conditions often associated with significant visual loss and characterized by elevated intraocular pressure (IOP) and optic-disk cupping. Successful IOP control is crucial but challenging and most often achieved surgically, with medical therapy playing a supportive role. There are many classifications of childhood glaucoma, but they can simply be divided into primary, in which a developmental abnormality of the anterior chamber angle only exists, and secondary, in which aqueous outflow is reduced due to independent mechanisms that secondarily impair the function of the filtration angle. The worldwide prevalence of childhood blindness ranges from 0.03% in high-income countries to 0.12% in undeveloped countries. The majority of cases do not have an identified genetic mutation and, where the mutation is known, the genes often account for only a small proportion of cases. Several pathogenetic mechanisms are known to contribute to the development of childhood glaucoma. Whatever the cause, it results in a reduced aqueous outflow at the level of the trabecular meshwork. Age of onset and magnitude of the elevated IOP largely determine the clinical manifestation the high variability of clinical manifestations. Glaucoma from any cause in a neonate and infant is characterized by the classic triad of epiphora, photophobia, and blepharospasm, and could be associated with eye enlargement (buphthalmos) and Haab striae. The eye examination, usually performed under general anesthesia, includes: tonometry, anterior-segment examination, gonioscopy, corneal diameter and axial length measurement, dilated fundoscopy with optic-nerve-head evaluation. Medical therapy, considering the high frequency of side effects, is generally used as temporizing IOP-lowering treatment before surgery or as adjuvant treatment postoperatively in case of partially successful procedures for refractory glaucomas. Surgery is the nodal point of the management of refractory childhood glaucoma, so it is crucial to opt for a forward-looking strategy to reach the target IOP and minimize the visual loss. Keywords: childhood glaucoma, congenital glaucoma, glaucoma surgical therapy, childhood visual loss

Very low caloric diet and treatment with dietary fibre complement are useful for weight-reducing programmes for obese subjects. This was revealed from the comparison of the effect of a dietary fibre supplement with a placebo. The treatment indicated a uniform distribution of adipose tissue and no cardiovascular diseases, acute, and chronic liver diseases. The procedure and the result of the experiment are discussed.