Search

Purpose: To determine the incidence of clinically significant pseudophakic cystoid macular edema (CSPME) after phacoemulsification using the 'bag-in-the-lens' lens (BIL) implantation technique and to examine the influence of associated risk factors for clinically significant pseudophakic macular edema (CSPME), both ocular and systemic. Methods: This retrospective study included 2419 first-operated eyes of 2419 adults who underwent phacoemulsification cataract surgery using the BIL implantation technique between January 2013 and December 2018 in the Antwerp University Hospital, Belgium. The significance of several risk factors (age, gender, previous history, intra- and postoperative complications) was examined by extraction of electronic medical files. Results: The 3-month incidence of CSPME in the subgroup without risk factors was 0.00% (95% CI: 0.00 –NA). The 3-month incidence of CSPME in the subgroup with risk factors was 0.57% (95% CI 0.22–1.29%). The 3-month incidence of CSPME in the total population of 2419 patients was 0.29% (95% CI: 0.11–0.65%). The risk factors most significantly associated with CSPME included renal insufficiency (hazard ration [HR]: 5.42; 95% CI: 1.69–17.44; P =.014), exudative age-related macular degeneration (HR: 74.50, 95% CI: 25.75–215.6; P <.001) and retinal vein occlusion (HR: 22.48, 95% CI: 4.55–111.02; P =.005). Conclusions: In the absence of risk factors, the incidence of CSPME was zero. We can conclude that Primary Posterior Continuous Curvilinear Capsulorhexis (PPCCC) does not increase the risk for CSPME. Non-inferiority of the BIL implantation regarding the development of CSPME, relative to the traditional 'lens-in-the-bag' (LIB) implantation, confirms that BIL is a safe surgical technique. This study also illustrates a previously undescribed risk factor for developing CSPME, namely renal insufficiency. [ABSTRACT FROM AUTHOR]

Objectives: Corneal blindness is the third most frequent cause of blindness globally. Damage to the corneal endothelium is a leading indication for corneal transplantation, which is typically performed by lamellar endothelial keratoplasty. There are two conventional surgical techniques: Ultra-Thin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK) and Descemet Membrane Endothelial Keratoplasty (DMEK). The purpose of this study is to compare both techniques., Methods and Analysis: The trial compares UT-DSAEK and DMEK in terms of clinical and patient reported outcomes using a pragmatic, parallel, multicentric, randomised controlled trial with 1:1 allocation with a sample size of 220 participants across 11 surgical centres. The primary outcome is the change in best-corrected visual acuity at 12 months. Secondary outcomes include corrected and uncorrected vision, refraction, proportion of high vision, quality of life (EQ-5D-5L and VFQ25), endothelial cell counts and corneal thickness at 3, 6 and 12 months follow-up appointments. Adverse events will also be compared 12 months postoperatively., Ethics and Dissemination: The protocol was reviewed by ethical committees of 11 participating centres with the sponsor centre issuing the final definitive approval. The results will be disseminated at clinical conferences, by patient partner groups and open access in peer-reviewed journals., Governance of the Trial: Both, trial management group and trial steering committee, are installed with representatives of all stakeholders involved including surgeons, corneal bankers, patients and external experts., Trial Registration Number: NCT05436665., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)