Cataract

Eye disease affects billions worldwide, causing vision problems that impact daily life and productivity. This research focuses on eye health in coastal Bangladesh, a region with high poverty, limited healthcare access, and environmental risks that increase eye disease prevalence. The study evaluates a community-based eye screening program using Artificial Intelligence AI to detect conditions like diabetic retinopathy, glaucoma, cataracts, and age-related macular degeneration, aiming to improve early diagnosis and care in underserved areas. The program offers a twelve-step eye screening process supported by AI-assisted fundus imaging, combined with partnerships among local organizations and healthcare providers. Screening includes community outreach, vision tests, blood pressure and glucose checks, optometrist evaluations, and selective AI imaging for higher-risk individuals based on age, diabetes, hypertension, or symptoms. Patients diagnosed with severe cataracts are offered surgery through local or regional services. The approach integrates data collection, AI analysis, clinical examinations, counseling, and referrals to support comprehensive eye care. Participants aged 35 and older from the Char Fasson sub-district undergo screening and follow-up over several months. The study collects demographic, clinical, and imaging data securely, with informed consent for storing fundus images. Researchers monitor the number of individuals screened and the prevalence of eye diseases. Safety and data privacy are maintained using encrypted systems and compliance with ethical standards. The programs feasibility, cost, and effectiveness in improving eye care accessibility are assessed throughout the study.

This research aims to compare surgical outcomes and parameters between cataract surgeries performed using a new 3D imaging system called the NGENUITY4 3D Visualization System and the current standard binocular microscope in patients with high myopia. The study focuses on how differences in depth of field between these two systems affect factors during surgery and the results, including potential complications. Participants will have high myopia and significant cataracts requiring surgery. Participants will be randomly assigned to one of two groups one group will undergo cataract surgery using the standard binocular microscope, while the other group will have surgery using the Alcon NGENUITY4 3D Visualization System. During surgery with the NGENUITY system, the surgeon wears 3D glasses and views the operation on a 3D screen. Both groups receive standard cataract extraction with phacoemulsification and intraocular lens implantation. Throughout the surgery, researchers will measure how often and how far the microscope focus is adjusted, the distance needed to focus from the corneal surface to the lens capsule, total operation time, and ultrasound energy used. After surgery, participants will be followed for three months to monitor vision, eye pressure, and any complications. These assessments will occur on day 1, week 1, month 1, and month 3 after surgery to evaluate safety and effectiveness of the two visualization methods.

Researchers are evaluating the first use of a new imaging technology called 4D Microscope Integrated Optical Coherence Tomography 4D MIOCT combined with a Zeiss Artevo 800 surgical microscope during eye surgeries. This study focuses on adult patients undergoing clinically indicated surgery for various eye diseases, aiming to assess how easy the system is to use, its safety, and how well it visualizes the eyes structures during both front and back segment procedures. The study involves using the investigational 4D MIOCT device integrated into the Zeiss Artevo 800 microscope to capture detailed images of the eye during surgery. This imaging is performed in the operating room as part of the standard surgical care, with no additional treatment or interventions added. Up to eight patients may be enrolled, and images will be taken of one or both eyes during surgery to observe normal and abnormal microanatomy, as well as track any injections under the retina. Participants will have their eye imaged during surgery, and researchers will collect related clinical data and previous eye care records for comparison. The images and data will be analyzed after surgery to explore new details captured by the 4D MIOCT system. Researchers will measure ease of use, surgical workflow impact, and the presence of normal and abnormal microanatomy based on the images. There is no extra risk beyond the usual surgery, and no new medications or procedures will be performed solely for research purposes.

Researchers are evaluating two commercially available trifocal toric intraocular lenses to compare their clinical outcomes and patient satisfaction in people undergoing cataract surgery. The main goal is to compare the distance-corrected intermediate visual acuity provided by these lenses. Additionally, the study aims to assess and compare the safety of the two trifocal toric intraocular lenses designed to correct astigmatism and improve vision at near, intermediate, and distance ranges. Participants will be randomly assigned to receive one of two types of trifocal toric intraocular lenses Optiflex TRIO or AcrySof IQ PanOptix. Both lenses are single-piece, posterior chamber foldable intraocular lenses with advanced aspheric optics and a trifocal design intended to reduce dependence on glasses. The Optiflex TRIO features a refractive-diffractive trifocal toric optic with a square edge design, while the AcrySof IQ PanOptix has a diffractive trifocal optic with a toric component. Each participant will receive one of these lenses based on randomization during cataract surgery. During the study, participants will be monitored for visual acuity outcomes, focusing on binocular distance-corrected intermediate vision at six months after lens implantation. Researchers will also track patient satisfaction and safety throughout the study period. The study includes preoperative assessments such as corneal topography or keratometry to measure astigmatism and will involve follow-ups to evaluate visual performance and any adverse effects. The total duration of participation varies but includes at least a six-month follow-up for outcome measurement.

Researchers are conducting a prospective, randomized, multicenter study to compare three types of intraocular lens IOL implantations in adults with cataracts aged 40 years and older. The study is designed with two stages an initial three-arm enrollment followed by a head-to-head comparison based on data from the first stage. The trial evaluates vision outcomes after cataract surgery using different Clareon lenses to better understand their effects on visual acuity and patient satisfaction. The study involves three treatment groups bilateral Clareon PanOptix IOL implantation, bilateral Clareon PanOptix Pro IOL implantation, and a mixed approach with Clareon PanOptix Pro in one eye and Clareon Vivity in the other. Participants will receive their assigned lens implantations during cataract surgery. The study is masked so that subjects and vision assessors do not know which lenses are implanted to ensure unbiased evaluation. Participants will be monitored for at least three months after surgery, during which several visual acuity measurements will be taken, including corrected distance, intermediate, and near vision under different lighting conditions. Patient-reported outcomes about visual disturbances and satisfaction with the lenses will be collected through questionnaires. The study also measures contrast sensitivity, refractive outcomes, and pupil size. Safety and vision improvements will be regularly assessed throughout the follow-up period.

Researchers are conducting a prospective, randomized study to compare two types of intraocular lenses IOLs, Clareon TruPlus and Clareon monofocal, in adults aged 22 years and older who require cataract surgery in both eyes. This study is designed with a parallel-group and double-masked approach, where participants and examiners will not know which lens was implanted, while surgeons will be aware. The primary goal is to evaluate vision outcomes at 3 months after surgery. Participants will receive bilateral implantation of either the Clareon TruPlus or the Clareon monofocal IOL, with spherical and toric models allowed based on standardized preoperative planning and clinical needs. The study uses a randomized assignment to either lens type, and both spherical and toric versions will be used depending on the patients corneal astigmatism and other factors. The study spans from preoperative planning through at least 3 months post-surgery to assess outcomes. During the study, participants will attend scheduled visits for eye exams and testing, including measurement of binocular corrected distance visual acuity at 4 meters three months after surgery. They will complete study questionnaires and undergo clinical evaluations to monitor their vision and eye health. Safety and vision outcomes will be closely followed throughout the study period, which lasts until July 2027.

Researchers are evaluating a smart bed-exit alert system designed to enhance safety and nursing care efficiency for adults awaiting cataract surgery. The study compares this system with standard nursing care during the preoperative waiting period, which lasts approximately 30 to 60 minutes while patients remain on a stretcher in the operating room holding area. This period poses risks as patients may attempt to leave the bed due to physiological or psychological reasons, increasing fall risk. Participants will be randomly assigned to either receive standard nursing care supplemented by the UNEO smart bed-exit alert system or to receive routine nursing care without the device. The alert system uses a pressure-sensing mattress to detect body position and bed-exit attempts, sending immediate audible and tablet notifications to nursing staff when predefined thresholds are met. The control group receives care following usual clinical practice without the alert system. During the study, participants will be monitored for patient care requests, attempts to leave the bed, frequency of nurse bedside visits, and the amount of nursing care time during the preoperative waiting period. These measures help assess whether the smart bed-exit alert system improves workflow and patient safety. The study is expected to complete by the end of 2026, with participation involving approximately 30 to 60 minutes in the preoperative area.

Researchers are evaluating the effects of MELT-300 on procedural sedation in adults undergoing cataract extraction with lens replacement CELR. This Phase 3 clinical trial aims to compare MELT-300 with a placebo and an active comparator, sublingual midazolam, to assess the contribution of ketamine in the combined drug product. The study focuses on the effectiveness and safety of MELT-300 during and after cataract surgery. Participants will be randomly assigned to one of three groups MELT-300 a sublingual tablet containing 3 mg midazolam and 50 mg ketamine, midazolam alone 3 mg sublingual tablet, or a placebo tablet. They will receive a single dose of the assigned medication approximately 30 minutes before surgery without food or water. The surgery will be performed under topical anesthesia, and the study medication effects will be assessed before, during, and after the procedure. Participants will be admitted on the day of surgery and monitored throughout. Researchers will assess sedation levels, the need for additional sedation or pain medication, and the ability to complete surgery. Safety will be tracked through adverse event monitoring, vital signs, and physical exams at baseline, during surgery, and up to three days after medication. The primary outcome measured is the percentage of participants achieving successful procedural sedation at various time points on the day of surgery.

Researchers are studying adaptive optics, a new imaging method, to improve the way retinal diseases are diagnosed, treated, and managed. This observational study includes 350 participants with various eye diseases and 250 healthy volunteers aged 12 and older. The goal is to better detect retinal problems earlier than current methods allow, by comparing images from normal and diseased eyes. Participants will undergo comprehensive eye exams including visual acuity, intraocular pressure checks, pupil dilation, and adaptive optics imaging using specialized instruments at the National Eye Institute Eye Clinic. Additional tests may include perimetry, color vision tests, and electroretinograms involving numbing eye drops and special contact lenses. Imaging and assessments will be repeated as needed during one or more study visits. During their visits, participants will provide medical and eye history, answer questions about medications, and have their pupils dilated for imaging. Adaptive optics imaging requires participants to look steadily into an instrument while images of their retina are captured. Researchers will analyze these images qualitatively and quantitatively to compare healthy and diseased eyes. The study will last up to five years, with ongoing monitoring of image quality and retinal health.

Researchers are evaluating a new handheld optical coherence tomography OCT device designed to automatically align with the eye to capture detailed retinal images. This pilot study aims to assess this advanced imaging technology in healthy adult volunteers, adult patients, and pediatric patients with eye and retinal diseases, addressing current challenges in imaging uncooperative patients, especially children. The study is observational and led by Duke University, focusing on improving imaging speed, alignment, and data quality for retinal assessment. The study uses a Swept Source OCT system with enhanced hand-held probe technology that auto-aligns to the patients eye and detects image quality in real time, automatically saving optimal images. Participants include 20 healthy adults, 20 adult patients, and 10 pediatric patients from ophthalmology clinics. Imaging will be performed during clinical visits, with up to four single imaging sessions over two years to capture detailed retinal structure and blood flow. Participants will undergo retinal imaging using the handheld OCT device during their clinical visits. Researchers will analyze images for retinal microanatomy abnormalities and retinal thickness at specific eye regions, collecting data securely for further analysis. The study will monitor outcomes over multiple sessions for up to two years, with no known risks reported from prior handheld OCT use. The total participation duration depends on the number of imaging sessions completed within the study timeframe.