Corneal nerves and amyotrophic lateral sclerosis: an in vivo corneal confocal imaging study.

OBJECTIVES: Amyotrophic lateral sclerosis (ALS) is a severe motor neuron disorder. Diagnosis is challenging due to its clinical heterogeneity and the absence of definitive diagnostic tools, leading to delays averaging between 9.1 and 27 months. In vivo corneal confocal microscopy, assessing the sub-basal nerve plexus of the cornea, has been proposed as a potential biomarker for ALS. We aimed to determine whether the assessment of corneal nerves using in vivo confocal microscopy can serve as an imaging biomarker for ALS. METHODS: A single-centre prospective case-control study was conducted in France from September 2021 to March 2023 including patients with ALS according to the revised EI Escorial criteria. The corneal sub-basal nerve plexus was analysed using in vivo confocal microscopy. An automated algorithm (ACCMetrics) was used to evaluate corneal parameters: nerve fibre density, nerve branch density, nerve fibre length, nerve fibre area, nerve total branch density, nerve fibre width, and nerve fractal dimension. RESULTS: Twenty-two patients with ALS and 30 controls were included. No significant differences were found between ALS and control groups for all corneal parameters (p > 0.05). Corneal sensitivity did not differ between groups, and no correlation was identified between corneal nerve parameters and ALS disease duration, severity and rate of progression (p > 0.05). CONCLUSIONS: The present study does not support the use of in vivo corneal confocal microscopy as an early diagnostic or prognostic tool for ALS. Further research, especially longitudinal investigations, is needed to understand any potential corneal innervation changes as ALS progresses.

NOVATIVE: A Phase II/III, Multicenter, Double-masked, Randomized Study of Cyclosporine A 0.05% and 0.1% Ophthalmic Cationic Emulsion Versus Vehicle in Patients with Vernal Keratoconjunctivitis.

PURPOSE: This study evaluates the efficacy and tolerability of cyclosporine A cationic emulsion (CsA-CE) in patients ≥4 years of age with moderate-to-severe vernal keratoconjunctivitis (VKC). METHODS: This Phase II/III, multicenter, double-masked, dose-ranging study had 2 treatment periods: a 4-week, randomized, vehicle-controlled period in which patients received 0.05% CsA-CE, 0.1% CsA-CE, or vehicle eye drops 4 times daily (period 1) and a 3-month period in which patients received 0.05% CsA-CE or 0.1% CsA-CE 2 or 4 times daily (period 2). The primary efficacy end point was rating of subjective symptoms at day 28 in period 1 per the BenEzra scale. FINDINGS: All groups showed improvement in subjective VKC symptoms at day 28, without a statistically significant difference between 0.05% or 0.1% CsA-CE vs vehicle. Both CsA-CE doses produced statistically significant improvements in corneal fluorescein staining scores vs vehicle at day 28; improvements were evident as early as week 1 and continued through month 1. Progressive reduction in subjective itching was evident after week 1 and continued through month 1. Treatment for an additional 3 months further improved subjective symptoms and objective signs of VKC in both CsA-CE groups. Improvement was most notable with 0.1% CsA-CE in patients with severe keratitis. The safety and tolerability profile is favorable. IMPLICATIONS: Although treatment with 0.05% and 0.1% CsA-CE showed clinical efficacy in alleviating keratitis and itching as early as week 1, with sustained benefit through 1 month, the primary efficacy end point was not met. These findings informed the design of the Phase III trial of 0.1% CsA-CE (Vernal Keratoconjunctivitis Study). CLINICALTRIALS: gov identifier: NCT00328653.

Educational Concerns About the Safety of Cataract Surgery During Residency: The E3CAPS Pedagogic Study.

INTRODUCTION: Cataract surgery is the most common surgical procedure performed in France. While the incidence of intraoperative complications affecting visual prognosis is extremely low, given the large number of patients operated on, the absolute number of patients affected by complications is quite high. Complication rates are significantly higher when ophthalmology residents (ORs) perform the surgery. Although lack of experience remains the main risk factor, sleep deprivation may adversely affect ORs' successful surgery rate. The value of the EyeSi® surgical simulator in initial training has been demonstrated to increase cataract surgery safety through the transfer of surgical skills from the simulator to the operating room. However, there is no consensus regarding how much training is needed before the first-time ORs are allowed to operate. There is also no scientific evidence that sleep deprivation is associated with a decrease in surgical performance. Establishing a validated protocol for cataract surgery training using the EyeSi surgical simulator (referred to further as the EyeSi) and identifying risk factors for intraoperative complications related to sleep deprivation will improve cataract surgery safety and lead to the reorganization of our healthcare systems. METHODS AND PLANNED OUTCOMES: This multi-centre educational cohort study will include two distinct axes which will both aim to reduce the risks of cataract surgery. Enrollment will include 16 first-year ORs for Axis 1 and 25 experienced residents for Axis 2, all from the University Hospitals of Nantes, Tours, Angers and Rennes. Axis 1 will focus on investigating the learning curve of first-year ORs using the EyeSi, following the training program recommended by the "College des Ophtalmologistes Universitaires de France" in order to set up a future "licence to operate." Axis 2 will evaluate the impact of sleep deprivation on the surgical performance of experienced ORs using the EyeSi. TRIAL REGISTRATION: ClinicalTrial.gov identifier: NCT05722080.

Cost Utility and Value of Information Analysis of Femtosecond Laser-Assisted Cataract Surgery.

Importance: The efficacy and safety of femtosecond laser-assisted cataract surgery is well documented. An important requirement for decision makers is the evaluation of the cost-effectiveness of femtosecond laser-assisted cataract surgery (FLACS) over a sufficiently long horizon. Evaluating the cost-effectiveness of this treatment was a preplanned secondary objective of the Economic Evaluation of Femtosecond Laser Assisted Cataract Surgery (FEMCAT) trial. Objective: To estimate the cost utility of FLACS compared with phacoemulsification cataract surgery (PCS) on a 12-month time horizon. Design, Setting, and Participants: This multicenter randomized clinical trial compared FLACS with PCS in parallel groups. All FLACS procedures were performed using the CATALYS precision system. Participants were recruited and treated in ambulatory surgery settings in 5 university-hospital centers in France. All consecutive patients eligible for a unilateral or bilateral cataract surgery 22 years or older with written informed consent were included. Data were collected from October 2013 to October 2018, and data were analyzed from January 2020 to June 2022. Interventions: FLACS or PCS. Main Outcomes and Measures: Utility was measured through the Health Utility Index questionnaire. Costs of cataract surgery were estimated by microcosting. All inpatient and outpatient costs were collected from the French National Health Data System. Results: Of 870 randomized patients, 543 (62.4%) were female, and the mean (SD) age at surgery was 72.3 (8.6) years. A total of 440 patients were randomized to receive FLACS and 430 to receive PCS; the rate of bilateral surgery was 63.3% (551 of 870). The mean (SD) costs of cataract surgery were €1124.0 (€162.2; US $1235) for FLACS and €565.5 (€61.4; US $621) for PCS. The total mean (SD) cost of care at 12 months was €7085 (€6700; US $7787) in participants treated with FLACS and €6502 (€7323; US $7146) in participants treated with PCS. FLACS yielded a mean (SD) of 0.788 (0.009) quality-adjusted life-years (QALYs), and PCS yielded 0.792 (0.009) QALYs. The difference in mean costs was €545.9 (95% CI, -434.1 to 1525.8; US $600), and the difference in QALYs was -0.004 (95% CI, -0.028 to 0.021). The incremental cost-effectiveness ratio (ICER) was -€136 476 (US $150 000) per QALY. The cost-effectiveness probability of FLACS compared with PCS was 15.7% for a cost-effectiveness threshold of €30 000 (US $32 973) per QALY. At this threshold, the expected value of perfect information was €246 139 079 (US $270 530 231). Conclusions and Relevance: The ICER of FLACS compared with PCS was not within the $50 000 to $100 000 per QALY range frequently cited as cost-effective. Additional research and development on FLACS is needed to improve its effectiveness and lower its price. Trial Registration: ClinicalTrials.gov Identifier: NCT01982006.

[Management of binocular diplopia in the department of ophthalmic emergencies at the Regional University Hospital of Tours]. / Prise en charge des diplopies binoculaires aux urgences ophtalmologiques du Centre hospitalier régional universitaire de Tours.

OBJECTIVES: To describe the etiologies of binocular diplopia for patients presenting to the ophthalmologic emergency department of the Regional University Center Hospital (CHRU) of Tours. METHODS: This is a retrospective study of the medical records of patients who presented with binocular diplopia in the ophthalmic emergency department of the CHRU of Tours between January 1st and December 31st, 2019. Binocular diplopia was classified as paralytic or non-paralytic according to the ocular motility examination. RESULTS: One hundred twelve patients were included. The median age was 61 years. Internal referral from other hospital services represented 44.6% of the patients. On ophthalmological examination, 73.2% had paralytic diplopia, 13.4% non-paralytic diplopia and 13.4% normal examination. Neuroimaging was performed in 88.3% of cases, with 75.7% of patients receiving it on the same day. Oculomotor nerve palsy was the most frequent cause of diplopia in 58.9%, the majority represented by abducens nerve palsy (60.6%). The most frequent etiology of binocular diplopia was ischemic, with microvascular damage in 26.8% of cases and stroke in 10.7% of cases. CONCLUSION: Among patients assessed in an ophthalmological emergency department setting, one in ten patients had stroke. It is essential to inform patients of the urgent nature of ophthalmological evaluation in the case of acute binocular diplopia. Urgent neurovascular management is also mandatory and should be based on the clinical description provided by the ophthalmologist. Neuroimaging should be performed as soon as possible, based on the ophthalmologic and neurological findings.

Ciclosporin A Cationic Emulsion 0.1% for the Management of Dry Eye Disease: Facts That Matter for Eye-Care Providers.

Dry eye disease (DED) is a chronic inflammatory disease of the ocular surface requiring long-term therapy. Severe forms of DED generally do not respond to tear substitutes alone or combined, and often require treatment with topical anti-inflammatory agents to break the vicious circle of inflammation. This review summarises data from randomised controlled trials and real-world evidence on the efficacy and safety of ciclosporin A 0.1% cationic emulsion (Ikervis®) for the management of DED. Improvements in clinical signs and symptoms were reported from as early as 4 weeks after treatment initiation, although it can take a few months to reach the full benefits. Treatment periods of up to 12 months provide sustained benefit to patients. In the most responsive patients, treatment discontinuation is possible with no further substantial relapse over 12 months in over 65% of patients. Transient local ocular effects are the most commonly reported adverse events.

Validation of metabolomic and lipidomic analyses of human tears using ultra-high-performance liquid chromatography tandem mass spectrometry.

To facilitate application in ophthalmological and systemic diseases, there is a need to standardize preanalytical and analytical steps for metabo-lipidomics in human tears. We assessed different methods for each step of the workflow, from sampling to omics profiles acquisition, to provide the largest metabo-lipidomic coverage with the most robust analytical criteria in human tears. We compared reproducibility according to different extraction methods, two sampling techniques, three volumes (2 µL, 5 µL, 10 µL) and eye laterality using ultra-high-performance liquid chromatography coupled with tandem high-resolution mass spectrometry for metabolomic and lipidomic application. The effect of age on the tear metabo-lipidome was also investigated in healthy subjects. The extraction method using methanol/water provided the best results for Schirmer strip metabolomics, while Folch extraction was superior for lipidomics, whatever the sampling method used. When comparing both sampling methods, microcapillary glass tube was superior to Schirmer strip for metabolomics but comparable for lipidomics. The 5 µL volume provided a satisfying metabo-lipidomic coverage. There was no significant difference in tear metabo-lipidome between both eyes in healthy subjects. While most metabolites and lipids where not influenced by age, the phenylalanine-tyrosine-tryptophan pathway, aminoacyl t-RNA biosynthesis, and alanine-aspartate-glutamate metabolism were the 3 principal pathways associated with the 15 most variable metabolites according to age. The current findings will contribute to improve metabo-lipidomic workflow in human tears for the identification of new biomarkers. Preanalytical and analytical standardization is mandatory in order to perform better between-study comparisons and increase the chances of transferring laboratory findings into clinical practice.

A Rare Case of Didanosine-Induced Mid-Peripheral Chorioretinal Atrophy Identified Incidentally 11 Years after the Drug Cessation.

Objective: This article aims to describe a unique case of didanosine-induced retinal degeneration that was discovered 11 years after the drug withdrawal. Case report: The patient is a 42-year-old woman with a medical history of HIV and hepatitis C virus since 2004. She has been prescribed antiretroviral therapy since then. For the first seven years (2004-2011), the patient was prescribed a combination therapy consisting of didanosine, efavirenz, and lamivudine. The protocol was changed to atripla (efavirenz, emtricitabine, and tenofovir) from 2011 to 2021. Recently (October 2021-January 2021), the patient was prescribed eviplera (rilpivirin, emtricitabine, and tenofovir). In addition, her past medical history revealed Gougerot-Sjogren syndrome and rheumatoid arthritis. She was prescribed hydroxychloroquine (HCQ) (2009-2021) at a dose of 400 mg daily. She had no vision complaint. Results: During her routine HCQ screening at the eye clinic, University Hospital Bretonneau, Tours, France, the widefield colour fundus photograph showed well-defined symmetric mid-peripheral areas of chorioretinal atrophy sparing the posterior pole of both eyes. Furthermore, the widefield fundus autofluorescence illustrated mid-peripheral round well-demarcation hypoautofluorescent areas of chorioretinal atrophy of both eyes. Conversely, the macular optical coherence tomography (OCT) was normal. Many of her drugs are known to be associated with retinopathy such as HCQ, tenofovir, efavirenz, and didanosine. Because our data corroborate peripheral retinal damage rather than posterior pole damage, this case report is compatible with didanosine-induced retinopathy rather than HCQ, efavirenz, or tenofovir retinal toxicity. Conclusions: All HIV patients who are presently or were previously on didanosine therapy should have their fundus examined utilising widefield fundus autofluorescence and photography.

Long-term functional outcomes and vision-related quality of life after vitrectomy for epiretinal membrane: a prospective cohort study.

To investigate the long-term effect of unilateral idiopathic epiretinal membrane (uiERM) removal on monocular and binocular visual function, and on vision-related quality of life (VR-QoL). Prospective, single-center study. The following data were collected before and after surgery: distance monocular and binocular best-corrected visual acuity (BCVA), horizontal and vertical metamorphopsia, horizontal and vertical aniseikonia, stereoacuity and National Eye Institute Visual Function Questionnaire-25 item (NEI VFQ-25). Forty-two patients (mean age: 72.7 ± 7.4 years; 24 men) were included. At 6 months postoperatively, distance monocular BCVA (p < 0.001), horizontal metamorphopsia (p = 0.001) and the composite score of NEI VFQ-25 (p < 0.001) significantly improved, in comparison to baseline. At 2 years postoperatively, distance monocular (p < 0.001) and binocular (p = 0.01) BCVA, horizontal (p < 0.001) and vertical (p = 0.02) metamorphopsia, vertical aniseikonia (p = 0.01), stereoacuity (p < 0.001) and 3 subscales scores of the NEI VFQ-25 (p < 0.05) ("general vision", "mental health", "driving") significantly improved in comparison to baseline. Removal of uiERM improves VR-QoL and achieves good visual outcomes on both monocular and binocular visual parameters over long-term. Visual symptoms induced by macular contraction have different improvement kinetics after surgery. Stereopsis, the highest level of binocular vision, can be improved in some cases.

Strabismus outcomes after surgery: the nationwide SOS France study.

PURPOSE: To describe the types of strabismus operated on, the surgical procedures performed, and the 2-year reoperation rate in France. METHODS: Entire population 5-year cross-sectional analysis of a national medico-administrative database in France between January 2013 and December 2017 included all patients who underwent a first strabismus surgery, with a 2-year follow-up. Patient identification was based on the diagnostic codes of the 10th International Classification of Diseases and surgical procedures on the codes of the Common Classification of Medical Acts. A subgroup analysis comparing non-paralytic and paralytic strabismus was performed. RESULTS: Among the 56,654 patients included (women: 50.8%), 26,892 (47.5%) patients were under 10 years old. Overall, 52,711 (93%) were diagnosed with non-paralytic strabismus and 3,943 (7%) with paralytic strabismus. Among the non-paralytics, the most frequent diagnosis was esotropia (21,282, 37.6%), followed by exotropia (14,392, 25.4%) and vertical strabismus (2,017, 3.6%). Among the paralytics, fourth cranial nerve palsy (1,499, 2.6%) was more frequent than sixth cranial nerve palsy (691, 1.2%) and third cranial nerve palsy (431, 0.8%). The 2-year reoperation rate was 7.7% (4,362 patients), the lowest for non-paralytic (7.4%) and the highest for paralytic (11.4%). CONCLUSION: This first French population-based study about strabismus will contribute to the evaluation of practices at a national level and permit comparisons between countries. Although the 2-year reoperation rate was found to be 1 out of 13 patients, it should be interpreted with caution. Long-term follow-up is still warranted due to considerable variability of the type and severity of strabismus as well as surgical practices.

Metabolomics and lipidomics approaches in human tears: A systematic review.

The human tear film is at the interface between the ocular surface and the external environment. Although investigation has been hindered by its small volume, improvements in preanalytical and analytical methods have allowed the omics approach to represent an innovative biomarker search strategy. There is still a significant lack of standardization, representing a barrier for performing between-studies comparisons and transferring experimental findings into clinical use and trials. We summarize the preanalytical and analytical procedures, describe the biomarkers that can be found using the metabo-lipidomics approach, and provide our expert opinion for omics investigations in human tears. For this systematic review of 38 studies, we searched PubMed by combining Boolean operators with the following keywords: tear, metabolomic, lipidomic, -omics. The human tear metabo-lipidome has been well-characterized in normal individuals using high-resolution liquid chromatography coupled with mass spectrometry. Lipid and metabolite profiles were influenced by ocular (e.g., dry eye disorders; Meibomian gland dysfunction; contact lens wear; glaucoma; keratoconus; pterygium) and systemic conditions (e.g., multiple sclerosis). Investigating the tear metabo-lipidome could improve our understanding of the pathogenesis of both ocular and systemic diseases, but also provide diagnostic as well as prognostic biomarkers.

Calcium oxalate crystals retinopathy following domino liver transplant: A case report.

INTRODUCTION: Hyperoxaluria is a rare cause of hereditary crystalline retinopathy. We report the first case of acquired calcium oxalate crystalsretinopathy following domino liver transplantation (DLT). CLINICAL CASE: A 72-year-old patient was referred for bilateral visual impairment 9 months after DLT. Slit lamp examination was unremarkable. Fundus examination revealed calcium oxalate crystals accumulation within both retina. Owing to multi-organ failure, the patient underwent combined liver-kidney retransplantation. During the following two years, calcium oxalate crystals accumulation within the retina gradually decreased and visual acuity improved. Nevertheless, OCT-angiography revealed abnormalities in the inner and outer retinal vascular plexus (i.e. retinal vessels occlusion and dilatation). Visual field examination revealed bilateral constriction associated with decreased optic nerve fibre layer thickness suggesting optic nerve atrophy. CONCLUSION: This case highlights the need for ophthalmologists to consider the diagnosis of acquired hyperoxaluria in patients with progressive bilateral visual impairment following DLT, especially if the postoperative course is marked by renal failure. Moreover, even after liver-kidney transplantation with a conventional graft, visual function can remain impaired owing to maculopathy and optic atrophy.

Ambulatory cataract surgery centre without perioperative anaesthesia care: a prospective cohort study.

This study aims to evaluate the safety and patient satisfaction of a fast-track procedure for cataract surgery under topical anaesthesia without perioperative anaesthesia care. This is a prospective single-centre study including all cataract procedures in the Centre Ambulatoire de la Chirurgie de la Cataracte at the Hospital of Bourges between May and August 2018. Procedures were performed under topical anaesthesia without the presence of a nurse anaesthesiologist or anaesthesiologist, the patient had not fasted, and no peripheral venous line was placed. Only heart rate and oxygen saturation were monitored intraoperatively with pulse oximetry. Incidence and nature of intraoperative adverse events and surgical complications were recorded. Patient satisfaction was assessed using the Iowa Satisfaction with Anaesthesia Scale (ISAS). In total, 651 cataract surgeries were performed among which 614 (94.3%) were uneventful. Thirty (4.6%) intraoperative adverse events and 8 (1.2%) surgical complications were recorded. All surgeries were successfully completed. No medical emergency team intervention or hospital admittance was encountered. The mean ISAS score was 5.7/6, indicating high patient satisfaction. Cataract surgery in an ambulatory cataract surgery centre without perioperative anaesthesia care is a safe procedure with high patient satisfaction for screened patients. Anaesthesia ressources are scarce and may be more beneficial to more complex ophthalmic or non-ophthalmic surgeries.

Cardiovascular Adverse Events With Intravitreal Anti-Vascular Endothelial Growth Factor Drugs: A Systematic Review and Meta-analysis of Randomized Clinical Trials.

IMPORTANCE: Systemic safety of intravitreal anti-vascular endothelial growth factor (anti-VEGF) is a matter of debate and regular updates are necessary. OBJECTIVE: To evaluate systemic adverse events (SAEs) associated with intravitreal anti-VEGF drugs compared with non-anti-VEGF treatments in patients with ocular diseases. DATA SOURCES: Electronic searches were conducted in MEDLINE, Embase, and Cochrane Central Register of Controlled Trials databases from inception to July 7, 2020. STUDY SELECTION: Randomized clinical trials conducted in adults with retinal diseases who received intravitreal anti-VEGF drugs. DATA EXTRACTION AND SYNTHESIS: Studies and treatment characteristics and outcome data were extracted and analyzed, and study quality was evaluated. MAIN OUTCOMES AND MEASURES: Main outcomes were major cardiovascular events (MACEs) and total mortality. Secondary outcomes included nonocular hemorrhage, components of MACEs, other cardiovascular outcomes, serious SAEs, and all SAEs. RESULTS: A total of 74 randomized clinical trials were analyzed: 32 trials (43%) included 14 190 patients with age-related macular degeneration (AMD), 24 (32%) included 5424 patients with diabetic retinopathy (diabetic macular edema or proliferative diabetic retinopathy), 17 trials (23%) included 3757 patients with retinal vein occlusion, and 1 trial (1%) included 122 patients with myopic choroidal neovascularization. Anti-VEGF drug administration did not increase MACEs compared with control agents (odds ratio [OR], 1.16; 95% CI, 0.85-1.58) or total mortality (OR, 1.27; 95% CI, 0.82-1.96). There was an interaction (subgroup difference, P = .04) in mortality risk depending on the underlying disease with an increase (OR, 1.80; 95% CI, 1.03-3.16; P = .04) in the risk of death in patients with diabetic retinopathy; however, no increase was observed in patients with AMD or retinal vein occlusion. Administration of anti-VEGF drugs increased the risk of nonocular hemorrhage (OR, 1.46; 95% CI, 1.01-2.10), mainly in patients with AMD. CONCLUSIONS AND RELEVANCE: Intravitreal anti-VEGF was not associated with an increase in MACEs in the trials examined herein. Increased mortality in patients with diabetes and nonocular hemorrhages, especially in those with AMD, could represent a safety signal, but the evidence was not strong. However, continued surveillance of SAEs remains warranted.

Monocular and binocular visual parameters associated to vision-related quality of life in patients with epiretinal membrane: a prospective cohort.

PURPOSE: Binocular visual impairment related to unilateral idiopathic epiretinal membranes (uiERM) and its association with vision-related quality of life (VR-QoL) has not yet been investigated. This study aimed to explore binocular visual parameters (distance binocular best-corrected visual acuity (BCVA), aniseikonia, stereopsis) and VR-QoL in patients with uiERM. METHODS: We carried out a prospective single-centre cohort study. The following data were collected: VR-QoL (NEI VFQ-25), distance monocular and binocular BCVA, horizontal and vertical metamorphopsia (M-charts test), horizontal and vertical aniseikonia (NAT TEST) and stereoacuity (TNO test). Multiple linear regression analyses were performed to evaluate factors influencing VR-QoL. RESULTS: Forty-six patients with uiERM and visual complaints were included. Aniseikonia was found in 40 (80%) participants. Stereoacuity was poor (above 120 s of arc) in 46 (100%) participants. Distance monocular BCVA, horizontal metamorphopsia and horizontal aniseikonia were the factors associated with VR-QoL in patients with uiERM. CONCLUSIONS: In subjects presenting uiERM, aniseikonia is frequently found and stereopsis is constantly impaired. We advocate quantitative testing of metamorphopsia and aniseikonia in addition to BCVA for the assessment of global visual function. Further investigations are needed to evaluate the effect of vitrectomy on these parameters and VR-QoL. TRIAL REGISTRATION: EudraCT Number/ID RCB: 2016-A00252-49.

Ambulatory surgery centers: possible solution to improve cataract healthcare in medical deserts.

PURPOSE: To investigate the epidemiological impact of an ambulatory cataract surgery center providing a fast-track procedure without anesthetic evaluation on the access to cataract healthcare. SETTING: French nationwide study. DESIGN: Retrospective cross-sectional study. METHODS: The study included individuals undergoing cataract surgery from the French national administrative database of medical information. Data analyses focused on patients living in the Cher and neighboring areas. Epidemiological indicators of patient flow and healthcare efficiency were calculated. A medicoeconomic analysis was performed. RESULTS: Between 2012 and 2018, activity increased by +50.2% (3665 to 5506) interventions in the Cher area compared with a national increase of +22.7% (720 351/884 254), while maintaining a constant ophthalmologist workforce. The leakage ratio decreased by 5.9 points (26.3% to 20.4%), whereas the attractiveness and self-sufficiency ratios increased by 2.3 (8.6% to 10.9%) and 8.6 (80.6% to 89.2%) points, respectively. The age- and sex-standardized rate of healthcare utilization for cataract surgery increased by 4.3 points (11.6 to 15.9 cataract surgeries per 1000 inhabitants), making the Cher the second best French area in 2018 for the rate of cataract surgery despite ranking 96th of 109 French areas for ophthalmologist density. The cost of the cataract removal procedure was 523.99€ (666.22€ in the conventional operating room). CONCLUSIONS: An ambulatory cataract surgery center with a fast-track procedure could represent a solution in medical deserts to improve cataract healthcare without supplementary funding. Nonetheless, consulting activity should be optimized to detect eye disorders and schedule interventions.

Complications of cosmetic iris implants: French series of 87 eyes.

PURPOSE: Iris intraocular implants were developed to manage congenital or traumatic iris defects. However, they are also used to change the color of patient eyes. The aim of this retrospective series was to report complications in patients managed in France after cosmetic implantation. SETTING: Ophthalmological institutions and private ophthalmologists in France. DESIGN: Multicenter retrospective observational study. METHODS: Questionnaires were sent to all ophthalmology departments in university hospitals and to private ophthalmologists. This questionnaire listed demographic and clinical data for each implanted eye with a focus on safety, the description of ocular complications (corneal edema, endothelial cell loss, increased intraocular pressure, and intraocular inflammation), and the therapeutic management implemented. RESULTS: Forty-four questionnaires (87 eyes) were collected, and ultimately, 33 questionnaires (65 eyes) were considered complete and analyzed. Two types of implants were identified. Of the 65 eyes analyzed, only 5 eyes (7.7%) did not experience any complication and 60 eyes (92.3%) had at least 1 complication. The most commonly reported complication was corneal decompensation (78.5%). The diagnosis of glaucoma was made in over half (52.3%) of the cases. Explantation was needed in 81.5% of cases. The mean final visual acuity was 0.45 ± 0.08 logarithm of the minimum angle of resolution (logMAR) (0 to 2 logMAR). CONCLUSIONS: Several ocular complications with a decreased mean visual acuity were described in a young healthy population. In addition, patient information on the safety of this procedure appeared insufficient.

Femtosecond laser-assisted versus phacoemulsification cataract surgery (FEMCAT): a multicentre participant-masked randomised superiority and cost-effectiveness trial.

BACKGROUND: 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. METHODS: 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. FINDINGS: 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. INTERPRETATION: 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. FUNDING: French Ministry of Social Affairs and Health.