Cataract

Setting Location and Participants Selection of a target region within Bangladesh considered four factors that would facilitate successful screening: 1) Relatively high population density and adequate transportation network, 2) the presence of a Cyclone Preparedness Program (CPP) volunteer network, 3) An eye care hospital willing to serve referred clients, and 4) Support and assistance from local and regional government. Based on these criteria, the investigators selected and implemented the screening project in Char Fasson of coastal Bangladesh. Char Fasson is a sub-district (Upazila) of the Bhola District and has a population of 518,792. While the investigators initially considered another coastal sub-district of comparable size, Char Fasson was chosen because of data collection challenges in the original choice. Char Fasson showed greater levels of poverty and more limited healthcare access while governmental coordination was exemplary. Within Char Fasson, the investigators made special efforts to serve outlying, smaller islands within the sub-district. Partnership Team Successful delivery of the program relied on effective collaboration across a range of diverse partners, including major operational organizations, clinical affiliates, commercial suppliers, and technical advisors. The major partners responsible for day-to-day work included the organizer, Data Yakka (Palo Alto, California, USA) which is a healthcare technology company specializing in AI-assisted medical screening platforms and data management systems, the regional government (Char Fasson Upazila), the Bangladesh Disaster Preparedness Centre (BDPC, Dhaka), and the national government's Cyclone Preparedness Program (CPP, Dhaka). Among them, BDPC provided personnel for program execution and supervision while CPP mobilized its volunteers for paid work in clinical site staffing and program outreach to remote areas. The total number of CPP community volunteers in coastal Bangladesh is around 76,000, with 3,300 in Char Fasson. The main clinical partner was the Dr. K. Zaman Bangladesh National Society for the Blind Eye Hospital (BNSB, Mymensingh, Bangladesh), which provided on-site ophthalmology and optometry staffing as well as remote fundus image review and clinical consultation as needed. The Ad-din Medical College Hospital (Dhaka) provided additional resources. Clients requiring cataract surgery were referred to regional facilities vetted by BNSB or to services provided by the Ad-Din Hospital. Commercial supplier partners included VisionSpring (New York, New York, USA), a not-for-profit organization providing low-cost reading glasses that the program distributed free to those in need, Topcon Corporation (Tokyo, Japan) for its NW-500 robotic fundus imaging camera, and Aurolab (Madurai, India) for its HAWK I T2 slit lamp examination device. Thirona Retina (Nijmegen, Netherlands) supplied its RetCAD AI software algorithms for the detection of suspected DR, AMD, and glaucoma. The software evaluates image quality, generates heatmaps with deep learning, and provides disease likelihood scores. Previous research demonstrated that RetCAD showed high performance: 96% sensitivity and 94% specificity on the Messidor-2 dataset for DR, 95% sensitivity and 97% specificity on the private1 dataset for AMD, and 95% sensitivity and 86% specificity on the REFUGE dataset for glaucoma. Technical advisors, including Stanford University (Palo Alto, California, USA), Royal Victorian Eye and Ear Hospital (Melbourne, Australia), and Glaucoma Australia (Sydney, Australia), shared their expertise, guided technical program components, and provided external clinical oversight and case-by-case review for complex or unclear diagnosis. Data security The security and integrity of patient data was ensured through multiple layers of protection. The secure, encrypted patient data portal was developed by Data Yakka using Java (Oracle, Austin, Texas, USA) with Angular for data entry and Spring Boot for backend micro services management, including a program dashboard for real-time monitoring. Patient information was securely stored in PostgreSQL RDS (Amazon Web Services, Seattle, Washington, USA), while fundus images were stored in Amazon S3 with server-side encryption using managed keys. This protected all sensitive data from unauthorized access. Personal identifiers were segregated from clinical details to enhance patient privacy. Keycloak was implemented for secure authentication and authorization. A comprehensive audit trail was maintained, logging all user interactions (access, edits, and deletions) to ensure compliance with the European Union's General Data Protection Regulation (GDPR) and the U.S.'s Health Insurance Portability and Accountability Act of 1996 (HIPAA). This also provided immediate detection of potential data security threats. Finally, to enhance system reliability, the investigators deployed Multi-AZ, which enabled automatic failover, high availability in case of hardware disruptions, and disaster recovery. Ethical Considerations Ethical approval was obtained from the Institutional Ethical Committee of BNSB (reference date/number 118/2025). To comply with Bangladesh's data regulatory policies, consent was waived for most components of the screening process and was obtained for the fundus images (retina and optic disc) because they constitute personal health information, are stored electronically, and their use in the future is anticipated. Before taking fundus images, screening staff described the reason, purpose, acquisition, use, confidential storage, deletion, and withdrawal mechanism for the fundus images and the required personal information. Informed consent was then obtained from the participants, including their signatures to verify their voluntary participation. The study was conducted in strict compliance with Declaration of Helsinki and ethical international and country-specific requirements. 2.2 Screening \& Care Process Timeline The program duration was planned for 10 months. This paper covers the program's initial stage and is current as of early April 2025. From October to December 2024, the investigators carried out a three-month-long creation and refinement of the screening model and electronic platform. Next, in December 2024, the model was tested and further enhanced during a pre-opening testing period for troubleshooting and initial data collection. Between January 2025 and July 2025, full-time data collection is planned with participant recruitment and screening then follow-up. Process The implementation of participant recruitment, data collection, screening, and follow-up was separated into twelve steps. This standardized framework ensured the integration of screening with data collection and follow-up eye care services. Fundus imaging was offered selectively to higher-risk patients with specific criteria including: random blood glucose \>7.9 millimoles per liter (mmol/L), blood pressure ≥140/90 millimeters of Mercury (mmHg), age ≥50 years, or clinical suspicion of retinal pathology based on patient report or slit lamp examination. Data Analysis Statistical analyses will be performed using Microsoft Excel. After data collection and cleaning, the investigators calculated descriptive statistics, including percentages, means, and standard deviations (SD), to analyze proportions, central tendency, and dispersion of demographic and diagnostic data. For statistical comparisons, the calculations for statistical significance will use 2-tailed t-tests with a threshold of p\<0.05 considered statistically significant. Eye condition diagnosis was based on the presence of a condition in either one or both eyes. Estimates of cost will initially calculate costs associated with the first 8000 screened individuals. The investigators also projected trends in both screening numbers and costs through a hypothetical 6-month time point by extrapolating screening numbers and variable costs of the program to 6 months. Fixed costs are non-recurring, volume-independent expenses, including program computers, blood pressure and blood glucose measurement devices, and fundus imaging and slit lamp equipment. Variable costs include consumables and operation fees based on unit usage, calculated by multiplying unit costs by the total screening, such as consumable testing costs, eyeglasses distribution, and office supplies. Per-person cost breakdown followed a dual-tier approach: fixed costs were evenly allocated among all screened individuals, while marginal cost reflected the average variable expenditure per screening.

The objective of this study is to compare the surgical outcomes and parameters between cataract surgeries performed using the NGENUITY® 3D Visualization System (Alcon, TX, USA), a 3D imaging system, and the current standard binocular microscope in highly myopic patients. The focus is on evaluating the differences in depth of field and their impact on intraoperative parameters and outcomes. This prospective randomized controlled trial aims to enroll patients with both high myopia and cataracts requiring surgical intervention. Participants will be randomly assigned to undergo cataract surgery using the current standard binocular microscope (control group) or the NGENUITY® 3D Visualization System (Alcon, TX, USA) (study group). The study will compare intraoperative parameters, surgical outcomes, and the incidence of potential complications, including the frequency of microscope adjustments during surgery, total distance of adjustments during surgery, distance needed to achieve clear focus from the corneal surface to the posterior capsule, surgical duration, cumulative ultrasound energy during surgery, and occurrence of surgical complications.

The purpose of this project is to capture research images from microscope integrated Optical Coherence Tomography (MIOCT) integrated into a Zeiss Artevo 800 surgical microscope with an add-on investigational 3D OCT scanner (hereafter called the 4D MIOCT) in participants undergoing clinically-indicated surgical procedures for a range of ocular diseases. The researchers will evaluate normal and abnormal microanatomy of the eye, image during surgical procedures, and track subretinal injections for therapeutic delivery during surgery (volumes measured/analyzed from the OCT images after surgery). This study is an observational imaging study with no treatment interventions for research purposes. The population is 5 adult ophthalmic surgical patients scheduled for eye surgery at Duke Eye Center, Durham. Up to 8 patients may be enrolled due to potential for surgery scheduling changes that would not allow research imaging on a surgery day for up to 3 patients. Research activities consist of investigational 4D MIOCT integrated into Zeiss Artevo 800 imaging of the eyes during surgery and collection of clinical data and other imaging from the participant's medical record, clinical visit and surgical procedure. Additional imaging of the participant's eye performed for clinical care will be extracted from the medical record for comparison to the intraoperative images. In this initial pilot, comparisons will enable design of future studies for accuracy, precision and reproducibility of the research device in eye surgery. For study participants there is no additional risk to the participant beyond what is normal for their ophthalmic surgery. No medications or surgical interventions/activities will be performed for research purposes. Images will be captured during the standard care ophthalmic microsurgery. This research will utilize the data gathered during OCT imaging performed as described above. The data collected from the OCT systems will be analyzed offline to allow for image processing and alternate visualizations of the area under study. The data gathered from 4D MIOCT imaging will be compared to existing clinical studies (performed as part of standard of care) on the participant, should they exist, for the purpose of identifying whether new information is gained by 4D MIOCT. Researchers will review the participant's Medical Record for up to three eye care visits prior to surgery and record information related to ocular health, eye examinations and imaging and prior ophthalmic treatment. No additional clinical studies will be performed for the purpose of this study.

Trifocal lenses are part of the premium range of refractive-diffractive trifocal IOLs with advanced aspheric optics for excellent visual outcomes. They are single piece, posterior chamber foldable intraocular lenses. The optic is refractive-diffractive trifocal with the anterior surface being aspheric and the posterior surface with a square edge design. The lens is designed to provide all near, distance and intermediate vision and thereby reduce spectacle dependency. Toric version of trifocal intraocular lens is intended to correct astigmatism.

Prospective, Non-comparative, Post Market Clinical Follow Up Study to demonstrate safety and performance of Eyefill® S.C. and Eyefill® M.B. as viscoelastic devices for cataract surgery

Prospective, randomized, multicenter, multi-arm, subject and vision-assessor-masked, two stage study with Stage 1 as a three-arm initial enrollment period, followed by Stage 2 as a head-to-head study refined based on the Stage 1 data.

To assess the safety of the Helix Surgical System with cataract surgery and gain early evidence on intraocular pressure (IOP) -lowering effectiveness in subjects with mild-moderate primary open-angle glaucoma (POAG) and cataract.

This is a Phase 3, randomized, double-masked, placebo-controlled, parallel-cohort, multicenter study to evaluate the efficacy and safety of MELT-300 compared with placebo on procedural sedation in adult participants undergoing CELR. An active comparator, SL midazolam, is also included in the trial, in part, to confirm the benefit of inclusion of ketamine in the combined drug product. Approximately 528 participants will be enrolled in 3 parallel treatment arms to assess efficacy endpoints. Eligible participants will be admitted to the study unit on Day 1. Participants will be randomized prior to surgery 4:1:1 to 1. MELT-300 (i.e. 1 MELT-300 sublingual tablet which contains 3 mg midazolam and 50 mg of ketamine) 2. Midazolam (i.e. 1 matching midazolam sublingual tablet which contains 3 mg midazolam) 3. Placebo (i.e. 1 matching placebo sublingual tablet) Participants will receive study medication 30 (± 5) minutes, without food or water, before planned surgery start (defined as instillation of topical ocular anesthetic gel \[i.e.. 3 drops of chloroprocaine hydrochloride ophthalmic gel)\]. Efficacy assessments will be performed after study medication administration before surgery, intraoperatively, and postoperative on Day 1 (end of surgery defined as just prior to drape removal). Efficacy assessments will include assessments of sedation, need for rescue medication for sedation, need for rescue medication for pain, and the ability to complete the surgery. Safety will be monitored at baseline, intraoperatively, postoperatively on Day 1, and on Day 3 ± 1 day post dose of study medication. Safety assessment will include monitoring of AEs, vital sign measurements, and physical examinations.

Objective: The objective of this protocol is to collect and assess adaptive optics (AO) retinal images of normal and diseased eyes. Study Population: Three hundred and fifty (350) participants with eye diseases and 250 normal volunteers will be enrolled. Design: This is an observational protocol which will enroll 350 participants with various eye diseases and 250 age-matched healthy volunteers over five years. In general, participants will undergo a complete ophthalmic examination including assessments of visual acuity, intraocular pressure, and a dilated ocular examination. Imaging will be performed using adaptive optics instruments deployed in the NEI Eye Clinic. Outcome Measures: The primary outcome for this protocol is qualitative and quantitative assessment of the AO images with comparisons of normal and diseased states.

BACKGROUNDS Nowadays, phacoemulsification for cataract treatment is the most common surgical procedure performed and anesthetics procedure has been shifted from retrobulbar or peribulbar anesthesia to topical anesthesia (TA). Phacoemulsification under TA is proved to be a safe and low risk procedure with the incidence of adverse events requiring medical emergency team interventions to be 0.04%. However, it is not uncommon that patients can suffer from pain, anxiety and unpleasant visual sensation during this procedure. Complementary sedation has long been thought to alleviate the anxiety and pain of the patient during surgery with local anesthesia. Studies revealed that approximate one fourth of the patients underwent phacoemulsification under TA or retrobulbar anesthesia requested additional intravenous sedation of midazolam. However, the intravenous sedation, such as midazolam, propofol, or etomidate, increase the risk of additional anesthetic complications of heart rate, blood pressure, body temperature, and nausea, and therefore, anesthesia monitoring was mandatory during the surgery. Compared with intravenous sedation, oral sedation is less costly and less invasive. Studies with different oral sedation agents revealed different effect. In the study of 41 patients serving themselves as control, patients reported more pain and photophobia in the surgery with TA alone than the other with midazolam syrup and oral transmucosal fentanyl citrate. However, two studies comparing oral diazepam or triazolam with intravenous midazolam showed similar rate of anxiety and pain or noninferior satisfaction. Moreover, the randomized control trial containing 50 procedures in each groups revealed that patients received TA alone during phacoemulsification reported similar pain or anxiety level to those received complementary intravenous midazolam.