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Cataract surgery is one of the most common operations in health care. Femtosecond laser-assisted cataract surgery (FLACS) enables more precise ocular incisions and lens fragmentation than does phacoemulsification cataract surgery (PCS). We hypothesised that FLACS might improve outcomes in cataract surgery compared with PCS despite having higher costs. We did a participant-masked randomised superiority clinical trial comparing FLACS and PCS in two parallel groups (permuted block randomisation stratified on centres via a centralised web-based application, allocation ratio 1:1, block size of 2 or 4 for unilateral cases and 2 or 6 for bilateral cases). Five French University Hospitals enrolled consecutive patients aged 22 years or older who were eligible for unilateral or bilateral cataract surgery. Participants, outcome assessors, and technicians carrying out examinations were masked to the surgical treatment allocation until the last follow-up visit and a sham laser procedure was set up for participants randomly assigned to the PCS arm. The primary clinical endpoint was the success rate of surgery, defined as a composite of four outcomes at a 3-month postoperative visit: absence of severe perioperative complication, a best-corrected visual acuity (BCVA) of 0·0 LogMAR (logarithm of the minimum angle of resolution) or better, an absolute refractive error of 0·75 dioptres or less, and unchanged postoperative corneal astigmatism power (≤0·5 dioptres) and axis (≤20°). The primary economic endpoint was the incremental cost per additional patient who had treatment success at 3 months. Primary outcomes were assessed in all randomly assigned patients who met all eligibility criteria (missing data considered as failure). We used mixed logistic regression models or mixed linear regression models for statistical comparisons, adjusted on centres and whether cataract surgery was bilateral or unilateral. The study is registered with ClinicalTrials.gov, NCT01982006. Of the 907 patients (1476 eyes) randomly assigned between Oct 9, 2013, and Oct 30, 2015, 870 (704 eyes in FLACS group and 685 eyes in the PCS group) were analysed. We identified no significant difference in the success rate of surgery between the FLACS and PCS groups (FLACS: 41·1% [289 eyes]; PCS: 43·6% [299 eyes]); adjusted odds ratio 0·85, 95% CI 0·64–1·12, p=0·250). The incremental cost-effectiveness ratio was €10 703 saved per additional patient who had treatment success with PCS compared with FLACS. We observed no severe adverse events during the femtosecond laser procedure, and most of the complications in the FLACS group related to the primary outcome measures occurred during the phacoemulsification phase or postoperatively. Despite its advanced technology, femtosecond laser was not superior to phacoemulsification in cataract surgery and, with higher costs, did not provide an additional benefit over phacoemulsification for patients or health-care systems. French Ministry of Social Affairs and Health.

To investigate the cost-effectiveness of implementing iStent inject trabecular bypass stent (TBS) in conjunction with cataract surgery (Cat Sx) in patients with mild-to-moderate glaucoma from a societal perspective in France. The secondary objective was to explore the economic impact of iStent inject TBS in patients who comply to different degrees with their anti-glaucoma medications. A previously published Markov model was adapted to estimate the cost-effectiveness of treatment with iStent inject TBS + Cat Sx versus Cat Sx alone over a lifetime time horizon in patients with mild-to-moderate open-angle glaucoma in France. Progression was modeled by health states reflecting increasing stages of vision loss. Disease progression was obtained from the two-year randomized clinical trial assessing safety and effectiveness of both interventions. French specific health-state utilities and costs were obtained through a targeted literature review. Model structure and inputs were validated by French ophthalmologists. Outcomes were expressed as incremental cost per quality-adjusted life-year (QALY) gained. The robustness of results was tested through sensitivity analyses. iStent inject TBS + Cat Sx reduced the number of medications needed and risk of blindness. Incremental cost and QALYs were €75 and 0.065 leading to an incremental cost-effectiveness ratio (ICER) of €1,154/QALY gained. ICER ranged from dominating for non-persistent patients to €31,127 patients fully persistent with their medication regime. Results from one-way sensitivity analysis had a maximum ICER of €29,000 when varying input parameters. iStent inject TBS + Cat Sx had an 86% chance of being cost-effective at a willingness-to-pay threshold of €30,000 per QALY gained. Results demonstrate that iStent inject TBS + Cat Sx is a cost-effective intervention for intraocular pressure reduction when compared to Cat Sx alone in France.

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

Purpose: To evaluate and compare endothelial cell changes in phacoemulsification and manual small-incision cataract surgery (MSICS) in patients with uncomplicated senile cataracts. Methods: This was a prospective, tertiary care hospital-based, randomized, double-blinded interventional study. In total, 152 patients with an uncomplicated senile cataract of nuclear grade III and above were recruited. Exclusion criteria included patients with preoperative endothelial cell density (ECD) less than 1500 cells/mm3, a history of previous ocular surgery, any other coexisting ocular disease, and intraoperative or postoperative surgical complications. Preoperative and postoperative values of ECD and central corneal thickness (CCT) were measured, analyzed, and correlated with various factors. Results: Patients were randomized into two interventional groups-MSICS and phacoemulsification. Factors associated with significant drop in postoperative ECD following phacoemulsification were patients with advanced age (P = 0.01), higher grades of cataract (P = 0.01), and longer effective phacoemulsification time (P = 0.007). Shallow anterior chamber depth (ACD) was strongly associated with greater ECD loss in both groups (P < 0.0001). A threshold value of 2.86 mm of ACD was defined for minimal endothelial cell loss following phacoemulsification. CCT was observed to slightly increase postoperatively in both groups but was insignificant (P > 0.05). Conclusion: Both MSICS and phacoemulsification have similar postoperative visual outcomes. An increase in postoperative CCT is insignificant following surgery. Greater postoperative ECD loss is associated with phacoemulsification with advanced age, hard nuclear cataracts, and longer effective phacoemulsification time. ACD can be used as an essential parameter preoperatively to determine the choice of surgical technique between MSICS and phacoemulsification.

PurposeTo determine difference in surgically induced astigmatism (SIA), post-operative intraocular pressure (IOP) and axial length (AL) between single site and twin-site phacotrabeculectomy augmented with Mitomycin C (MMC).DesignProspective interventional randomised controlled study.MethodsIn a prospective interventional comparative study, eligible patients were scheduled for phacotrabeculectomy. They were randomised to either group A: single site or group B: twin-site phacotrabeculectomy with MMC 0.2 mg/mL. Axial length was measured by using Zeiss IOL master I, pre-operatively and at 1, 3, 6 and 12 months post-operatively. Corneal topography was performed using Bausch and Lomb Orbscan I pre-operatively and at 3, 6 and 12 months post-operatively to analyse surgically induced astigmatism. Vector analysis was used to analyse the surgically induced astigmatism.ResultsOne hundred and eight eyes of which 55 patients in group A, and 53 patients in group B were enroled for vector analysis. The mean preoperative astigmatic vector power was +0.89 ± 0.4 D and +0.97 ± 0.5 D in group A and B respectively. The mean post-operative astigmatic vector power was +0.78 ± 0.4 D in group A and +0.96 ± 0.5 D in group B at the end of 12 months. Corneal topography showed post-operative superior flattening (51.8% at 3 months and 55.4% at 12 months) in group A (P = 0.072) compared to superior steepening (59.6% at 3 months and 61.5% at 12 months) in group B (P = 0.977).ConclusionsThe two commonly used techniques of combined cataract and glaucoma surgery proved to be efficacious without significant difference in surgical induced astigmatism.

Objective To compare the efficacy of femtosecond laser-assisted cataract surgery (FLACS) and conventional phacoemulsification surgery (CPS) in treating postvitrectomy cataracts. Methods Prospective randomized controlled study. Patients who underwent cataract surgery after pars plana vitrectomy (PPV) were randomly divided into the FLACS group and the CPS group. Preoperative data of all patients were collected to compare intraoperative complications, average phacoemulsification energy (AVE), effective phacoemulsification time (EPT), postoperative intraocular pressure, corneal endothelial cell density (ECD), and best corrected visual acuity (BCVA). Results A total of 92 eyes were included in the analysis, with 47 eyes in the FLACS group and 45 eyes in the CPS group. The intraoperative AVEs and EPTs in the FLACS group were both lower than those in the CPS group ( P  < 0.05). In the FLACS group, incomplete prechopping and incomplete capsulorhexis occurred in 3 eyes (3/47, 6.38%), and incomplete lens dislocation occurred in 1 eye (1/47, 2.13%). In the CPS group, incomplete lens dislocation occurred in 2 eyes (2/45, 4.44%), and anterior capsule tears occurred in 1 eye (1/45, 2.22%). There was no statistically significant difference in intraoperative complications between the two groups ( P  > 0.05). Postoperatively, intraocular pressure (IOP) was lower in both groups than preoperatively, and there was no statistically significant difference in intraocular pressure between the two groups at three months postsurgery ( P  > 0.05). Three months postoperatively, the ECD in the FLACS group was greater than that in the CPS group, with less average endothelial cell loss (ECL) than that in the CPS group ( P  < 0.01). The BCVA in both groups improved to varying degrees compared with the preoperative values, with the FLACS group performing better than the CPS group on the first postoperative day ( P  < 0.05). There was no statistically significant difference between the two groups at one week, one month, or three months postoperatively (all P  > 0.05). Conclusion FLACS is safe and effective for treating post-PPV cataracts and, compared with CPS, facilitates early postoperative recovery with no difference in final visual acuity. Residual silicone oil in the anterior chamber post-PPV may lead to certain specific outcomes for FLACS. Although it may not affect surgical results, it is still noteworthy.

IntroductionPrimary angle-closure glaucoma (PACG) has a high prevalence and blinding rate across Asia. The first-line treatment of PACG is surgery, and phacotrabeculectomy remains the mainstream surgery for advanced PACG. However, it may cause vision-threatening complications with long learning curve. Minimally invasive glaucoma surgery has been gradually used in PACG combined with cataract surgery and achieved efficacy without excessive injury, of which goniotomy is the most commonly performed. Therefore, this study aimed to conduct a multicentre, non-inferiority randomised controlled clinical trial to compare the efficacy and safety of phacotrabeculectomy versus phacogoniotomy in advanced PACG.Methods and analysisThis is a non-inferiority multicentre randomised controlled trial and will be conducted at eight ophthalmic departments and institutes in China. 124 patients with advanced PACG will be enrolled and randomised to undergo phacotrabeculectomy or phacogoniotomy. Comprehensive ophthalmic examinations will be performed before and after the surgery. The primary outcome is the change of intraocular pressure at 12 months after surgery compared with the baseline intraocular pressure. An extended follow-up period of 36 months will be required. Cumulative success rate of surgery, intraoperative and postoperative complications, and number of anti-glaucomatous medications will also be compared between the groups as secondary outcomes.Ethics and disseminationEthical approval has been obtained from the ethical committee of Zhongshan Ophthalmic Center, Sun Yat-sen University, China (ID: 2021KYPJ090) and all subcentres. All the participants will be required to provide written informed consent. The results will be disseminated through scientific meetings and published in peer-reviewed journals.Trial registration numberNCT04878458.

Even the most experienced cataract surgeon can encounter stressful situations in the operating room. With the new edition of More Phaco Nightmares: Conquering Cataract Catastrophes , surgeons can be prepared to manage unavoidable complications with ease. Dr. Amar Agarwal, along with over 35 of today's cataract surgery leaders, explain all there is to know about phacoemulsification and bring their extensive experience with their own surgical nightmares. The book contains 5 sections that gradually escalate from the basics to nightmares, furnishing phaco surgeons with complicated scenarios and the essential guidance to assess, manage, and resolve. Featuring updated content and brand new, state-of-the-art chapters on a variety of complex situations, More Phaco Nightmares is the toolkit surgeons need to stay in control when facing unique and especially challenging intra- and postoperative complications. Sample chapters include: The Phaco Machine Air Pump, Gas-Forced Infusion, and Active Fluidics Intraoperative Floppy Iris Syndrome Single-Pass Four-Throw Pupilloplasty Management of Capsule Rupture at Cataract Surgery Malpositioned Intraocular Lens Optic Capture Glued Intraocular Lens Management and Prevention of Negative Dysphotopsia Pseudophakic Cystoid Macular Edema More than 350 illustrations and photographs supplement the text, providing visual as well as textual references for each case. Plus, an accompanying video website contains over 4 hours of new, original, high-quality video content, offering additional visual learning to demonstrate the techniques discussed. Offering cutting-edge information, More Phaco Nightmares: Conquering Cataract Catastrophes will guide surgeons on how to mitigate the common problems and unanticipated disasters that may arise for even the most experienced surgeons.

AimsTo determine the analgesic effect of supplemental intracameral lidocaine 1% during phacoemulsification under topical anaesthesia, and to assess the risk factors associated with pain.MethodsIn a double-masked, randomised, clinical trial, 506 patients undergoing phacoemulsification under topical anaesthesia were randomised to receive a supplemental intracameral injection of either 0.5 cc of 1% lidocaine (277 patients, 54.7%) or balanced salt solution (BSS) (229 patients, 45.3%). Patients were interviewed by a trained interviewer using a standardised questionnaire. The main outcome measure was intraoperative pain, scored on a visual analogue scale of 0–10. Logistic regression was performed to assess ORs.Results125 of 277 patients (45.1%) experienced pain in the lidocaine group, compared with 123 of 229 patients (53.7%) in the BSS group. The proportion of patients who experienced pain was significantly lower in the intracameral lidocaine group compared with the BSS group (multivariate OR 0.68, 95% CI 0.47 to 0.97; p=0.034). The median pain score (range) was 0.0 for intracameral lidocaine group compared with 1.0 for BSS group (p=0.039). Pain was more common in females (54.3% vs 43.6%; OR 1.56), non-Chinese (62.3% vs 46.9%; OR 2.13) and those who had previous cataract surgery to the fellow eye (55.3% vs 44.7%; OR 1.61).ConclusionThe use of 0.5 cc of 1% intracameral lidocaine during phacoemulsification under topical anaesthesia significantly reduces pain experienced by patients. Risk factors for pain include females, non-Chinese and previous cataract surgery.

Purpose To evaluate the impact of residual astigmatism on the optical and visual performance of an enhanced-monofocal isofocal intraocular lens (EM Isopure, BVI medical, Belgium) compared to a monofocal one (Micropure, BVI medical, Belgium). Methods Laboratory investigation and prospective, comparative and randomized clinical study. Optical quality was assessed on an optical bench for 2.0, 3.0, and 4.5 mm pupils. The effect of residual astigmatism was investigated from through-focus images recorded with increasing amounts of regular positive astigmatism induced with a deformable mirror. To evaluate the impact of residual astigmatism, 28 eyes of 28 patients were randomly assigned to either group. Residual astigmatism was induced with positive and negative cylinder lenses at 90 and 180°. Visual acuity (VA) was measured at each step. Results The optical performance of both IOLs was quite similar for 2.0 and 3.0 mm pupils. For 4.5-mm pupil, the EM Isopure showed a significant reduction of its optical quality in comparison with the monofocal IOL. When visual performance was evaluated, no statistically significant differences were found for any power of induced astigmatism. More differences were found when positive induced astigmatism was compared within each group, and VA was better when the astigmatism was induced at 180° vs. 90°. The greatest differences were found for and induced positive astigmatism of + 1.50D ( p  = 0.009 for Isopure and p  = 0.023 for Micropure). Conclusions The tolerance to residual astigmatism of the EM Isopure lens is similar to that of a reference monofocal lens with pupils up to 3.5 mm.