Statistical analysis plan for the phaco TIp position during clear corneal Phacoemulsification Surgery (TIPS) randomized controlled trial.

BACKGROUND: Cornea is the most important refractive media in the eye, and damage to the corneal endothelium is one of the most common causes of poor visual outcome following cataract surgery, particularly in those with predisposing factors. The role of phaco tip position during phacoemulsification on corneal endothelial damage is ambiguous, and there is no consensus regarding the most cornea-friendly phaco tip position (bevel-up or bevel-down). The objective of the trial is to compare the effect of phaco tip position (bevel-up vs. bevel-down) during phacoemulsification using direct chop technique on corneal endothelial cell count. METHODS AND DESIGN: TIPS is a randomised, multicentre, parallel-group, triple-masked (participant, outcome assessor, and statistician) trial with 1:1 allocation ratio. A total of 480 eligible participants, aged > 18 years with immature cataract, will be randomly allocated into bevel-up and bevel-down groups at two centres. Randomisation will be stratified according to the cataract grade. The primary outcome is postoperative endothelial cell count at 1 month. Secondary outcomes are central corneal thickness on postoperative days 1, 15, and 30 and difference in intraoperative complications. CONCLUSION: In this paper, we describe the detailed statistical analysis plan (SAP) for the TIPS trial, which was prepared prior to database lock. The SAP includes details of planned analyses and unpopulated tables, which will be reported in the publications. We plan to lock the database in July 2023 and publish the results later in the same year. SAP Version 0.1 (dated: 28 April 2023) Protocol version:2.0 TRIAL REGISTRATION: Clinical Trial Registry of India CTRI/2019/02/017464. Registered on 5 February 2019; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=29764&EncHid=&userName=2019/02/017464.

Reducing the carbon footprint of cataract surgery: co-creating solutions with a departmental Delphi process.

BACKGROUND: Climate change is arguably the greatest threat to global health of the 21st century. Although cataract surgery is a major contributor to global greenhouse gas emissions, recent literature review identified a paucity of evidence-based strategies for improving the environmental impact of cataract services. Our study aimed to assess the effectiveness of a departmental Delphi process for improving cataract services' environmental sustainability. METHODS: All members of ophthalmology theatre teams in a UK teaching hospital were invited to participate in a three-stage Delphi process. Team members were surveyed for suggestions for reducing the department's environmental impact. Suggested interventions were refined during a plenary face-to-face discussion and ranked. The highest ranked interventions were combined into a mutually agreed action plan. Data on the economic and environmental cost of cataract services was collected prior to and six months after the Delphi process using the Eyefficiency mobile application. RESULTS: Twenty-three interventions were suggested by a range of staff cadres. Interventions were ranked by 24 team members. The 2nd, 4th, 5th, 8th and 11th ranked interventions were combined into an "Eco-packs" project in collaboration with suppliers (Bausch + Lomb), saving 675 kg of waste and 350 kg of CO2 equivalent annually. CONCLUSIONS: The Delphi process is an effective method for provoking departmental engagement with the sustainability agenda that we would encourage all ophthalmology departments to consider utilising. The baseline per case CO2 equivalent measured in our department was reproducible and could serve as a maximum benchmark to be improved upon.

The Royal College of Ophthalmologists' National ophthalmology database study of cataract surgery: Report 14, cohort analysis - the impact of CapsuleGuard® utilisation on cataract surgery posterior capsule rupture rates.

BACKGROUND/OBJECTIVES: The aim of this study was to investigate whether the use of the silicone tipped irrigation/aspiration (I/A) handpiece CapsuleGuard® (Bausch + Lomb, Laval, Canada) reduced rates of posterior capsule rupture (PCR) during cataract surgery. METHODS: Royal College of Ophthalmologists' National Ophthalmology Database (NOD) Cataract Audit data from 01/04/2010 and 31/03/2021 and Bausch + Lomb sales figures were combined to identify centres participating in national cataract audit who have routinely adopted the silicone tipped I/A handpiece, CapsuleGuard®. Data were included only from centres with eligible cataract operations recorded on the NOD both before and after adopting CapsuleGuard®. Review of the literature was undertaken to estimate the proportion of PCR that occurs during I/A, to evaluate the impact of adoption of CapsuleGuard® on PCR occurring in this phase of surgery. RESULTS: Within the study period, 267 371 eligible cataract operations were performed in 14 centres with >50 eligible operations both before and after adopting CapsuleGuard®. Within centres adopting CapsuleGuard®, the rate of PCR occurrence reduction was 16.4%. Before and after the adoption of CapsuleGuard® the median change of PCR was 21.7% reduction (IQR: 4.8% to 37.7% reduction). CONCLUSIONS: A reduction in the rate of PCR was seen after regular adoption of CapsuleGuard® during cataract operations. Review of published studies attributing PCR to various components of the cataract operation suggest around 25% of PCR may occur during I/A; adoption of CapsuleGuard may, therefore, be associated with avoidance of a substantial proportion of the PCR during that phase of surgery.

The Royal College of Ophthalmologists' National Ophthalmology Database Study of Cataract Surgery: Report 13, monitoring post-cataract surgery endophthalmitis rates-the rule of X.

BACKGROUND: Cataract surgical safety has improved over recent decades, with endophthalmitis rates before 2006 typically 0.13-0.15% compared with the most recent UK national estimate of 0.02%. There remains, however, substantial variation in reported rates from different centres. Due to the low event rate, this disparity may not be noticed and opportunities to improve therefore be missed. We propose a method of monitoring post-cataract endophthalmitis rates that would help centres with higher rates identify this. METHODS: A statistical tool, available to download or use online, permits comparison of local endophthalmitis rate with the estimated UK rate of 0.02%. Centres are encouraged to maintain a register of endophthalmitis cases, and when the number reaches a threshold (X cases), either in a certain time period or in a fixed number of procedures, then the centre can consider itself as an outlier and trigger local investigations to improve infection control. RESULTS: Example outputs are offered, such as for a unit doing 5000 cataracts annually, a value of X is suggested such that the third case of endophthalmitis (X = 3) in a 12-month period would give 85% confidence, the fourth case 90% confidence and the fifth case 95% confidence that the true endophthalmitis rate for that unit was higher than the national average. CONCLUSIONS: This statistical tool provides a basis for units to set a threshold number of cases of endophthalmitis within a given period that would trigger local processes, thus helping inform local monitoring processes for this rare but potentially catastrophic complication of cataract surgery.

Eye Health Integration in Southern and Eastern Africa: A Scoping Review.

Integrated health systems are deemed necessary for the attainment of universal health coverage, and the East, Central, and Southern Africa Health Community (ECSA-HC) recently passed a resolution to endorse the integration of eye health into the wider health system. This review presents the current state of integration of eye health systems in the region. Eight hundred and twelve articles between 1946 and 2020 were identified from four electronic databases that were searched. Article selection and data charting were done by two reviewers independently. Thirty articles met the eligibility criteria and were included in the narrative synthesis. Majority were observational studies (60%) and from Tanzania (43%). No explicit definition of integration was found. Eye health was prioritized at national level in some countries but failed to cascade to the lower levels. Eye health system integration was commonly viewed in terms of service delivery and was targeted at the primary level. Eye care data documentation was inadequate. Workforce integration efforts were focused on training general health-care cadres and communities to create a multidisciplinary team but with some concerns on quality of services. Government funding for eye care was limited. The findings show eye health system integration in the ECSA-HC region has been in progress for about four decades and is focused on the inclusion of eye health services into other health-care programs. Integration of comprehensive eye care into all the health system building blocks, particularly financial integration, needs to be given greater emphasis in the ECSA-HC.

Does the phaco TIp position during clear corneal Phacoemulsification Surgery adversely affect corneal endothelium? TIPS study protocol for a randomised, triple-masked, parallel-group trial of bevel-up versus bevel-down phacoemulsification.

Introduction: Globally, at least 30 million cataract surgeries are required annually to prevent cataract-related blindness. Corneal endothelial decompensation is one of the most common causes of poor visual outcome following cataract surgery, particularly in those with predisposing factors. The increasing ageing population and reduced visual impairment threshold for cataract surgery have resulted in rising cataract surgical rates and hence, an increase in corneal endothelial decompensation is expected. The role of phaco tip position on corneal endothelial damage is ambiguous. Previous studies have reported contradictory results and were also underpowered to detect a significant difference due to small sample sizes. With no consensus regarding the most cornea-friendly phaco tip position (bevel-up versus bevel-down) during phacoemulsification, we propose a randomised clinical trial with a robust design using direct chop phaco-technique. Objective: To compare the effect of phaco tip position (bevel-up vs. bevel-down) on corneal endothelial cell count during phacoemulsification. Methods: A randomised, multicentre, parallel-group, triple-masked (participant, outcome assessor, and statistician) trial with 1:1 allocation ratio is proposed. By adopting stratified randomisation (according to cataract grade), we will randomly allocate 480 patients aged >18 years with immature cataract into bevel-up and bevel-down groups at two centres. History of significant ocular trauma, previous intraocular surgery, shallow anterior chamber, low endothelial cell count, pseudoexfoliation syndrome, intraocular inflammation, and corneal endothelial dystrophy are the key exclusion criteria. The primary outcome is postoperative endothelial cell count at one month. Secondary outcomes are central corneal thickness on postoperative days 1, 15, and 30, and intraoperative complications. Trial registration: Clinical Trial Registry of India CTRI/2019/02/017464 (05/02/2019).