Glaucoma

Eye disease affects 2.2 billion people worldwide and can lead to vision loss impacting daily life, work, and social activities. This research evaluates a community-based eye screening program in coastal Bangladesh, a region with high poverty, limited healthcare access, and elevated rates of eye diseases like cataracts, diabetic retinopathy, glaucoma, and age-related macular degeneration. The study explores the use of Artificial Intelligence (AI) to assist in early detection and improve accessibility and affordability of eye care in underserved areas. The screening process involves twelve organized steps managed by electronic health records, including community awareness, participant registration, vital signs measurement, vision testing, optometrist evaluation, and informed consent for imaging. Fundus imaging with AI analysis is selectively offered to higher-risk individuals, such as those with diabetes, hypertension, age 50 or older, or optometrist recommendations. Diagnosed cataract patients with moderate to severe visual impairment are offered surgery through local or regional services. The program uses advanced AI software and collaborates with multiple partners to deliver comprehensive eye screening and follow-up care. Participants undergo evaluations including blood pressure and blood glucose tests, vision assessment, imaging, AI-assisted disease detection, ophthalmologist review, counseling, and referral as needed. Data security and patient privacy are carefully maintained. The study measures the number of individuals screened over 12 months and analyzes demographic and diagnostic data to assess feasibility, performance, equity, and cost of the screening model. The project duration is approximately 10 months with ongoing recruitment, screening, and follow-up.

Researchers are evaluating the 24-hour effect on intraocular pressure (IOP) reduction of a fixed combination of netarsudil and latanoprost (Rocklatan) compared to latanoprost alone in adults with open angle glaucoma (OAG) or ocular hypertension (OHT). This Phase 4, double-masked, paired-contralateral study involves subjects aged 18 years or older who have OAG or OHT in both eyes. The goal is to understand how these treatments affect IOP over a full day when applied once daily at night. Participants will receive netarsudil-latanoprost fixed combination eye drops in one eye and latanoprost alone in the other eye, both dosed once daily at night for 14 consecutive days. This design allows direct comparison of the two treatments within the same individual. The total study duration, including any necessary washout from prior treatments, may last up to 10 weeks. During the study, participants will undergo eye exams including measurements of intraocular pressure, visual field tests, and retinal imaging. Researchers will track changes in mean IOP from baseline after 2 weeks of treatment with each medication. Safety and tolerability will also be monitored throughout. Participants must attend all visits, follow study instructions, and may be required to remove contact lenses before visits. The primary measure is the change in mean IOP after 2 weeks of treatment with each medication.

Researchers are evaluating a new imaging technology called 4D Microscope Integrated Optical Coherence Tomography (4D MIOCT) combined with a Zeiss Artevo 800 surgical microscope. The study focuses on adults undergoing eye surgery for corneal, retinal, or other ocular diseases. The goal is to assess how easy and safe the 4D MIOCT system is to use during various anterior and posterior segment eye surgeries and to visualize the eye's structures effectively. The 4D MIOCT device is integrated into the Zeiss Artevo 800 surgical microscope and includes an investigational 3D OCT scanner. This imaging system will be used during the participants' clinically-indicated eye surgeries without any additional treatment or surgical intervention for research purposes. The study is observational, capturing images during standard ophthalmic microsurgery and comparing them to other clinical images obtained as part of usual care. Participants will have their eye images recorded during surgery using the 4D MIOCT device. Researchers will also review medical records from up to three previous eye care visits to gather clinical data, including ocular health and prior treatments. The images and data will be analyzed after surgery to evaluate the device's performance and explore whether it provides new information beyond existing clinical imaging. There is no extra risk to participants beyond their scheduled surgery.

Young children often find standard visual field (VF) testing of peripheral vision challenging and not engaging, which leads to poor attention and unreliable test results. This affects the ability to accurately detect vision loss in children with conditions such as glaucoma suspect and optic nerve abnormalities. Researchers aim to develop a more engaging VF test that captures children's attention better, potentially improving the reliability of test results and enhancing diagnosis and care for pediatric peripheral vision loss. The study compares a new VF testing device that uses a small microdisplay video screen showing popular cartoon characters as a fixation target, along with audio instructions mimicking cartoon voices, against usual care VF testing procedures. The new device is designed to make the test more like a game for children ages 5 to 8, improving their focus and response consistency. Participants will complete VF testing at two visits about a week apart to compare results from the two approaches. During the study, children will undergo Humphrey visual field tests using either the cartoon-based device or usual care methods. Researchers will measure the test-retest variability of mean deviation scores over one week to assess reliability. The study includes consent, VF testing, and follow-up assessments to monitor performance and consistency. This approach aims to provide evidence on whether the engaging VF test can improve attention and reliability in pediatric vision testing.

Researchers are evaluating the safety, effectiveness, and plasma pharmacokinetics of 0.002% DE-117B eye drops in Chinese adults diagnosed with primary open angle glaucoma (POAG) or ocular hypertension (OHT). This Phase III study includes both a single-arm, open-label, multi-dose pharmacokinetics cohort and a randomized, evaluator-masked, active drug-controlled multicenter cohort. Participants will stop their current intraocular pressure (IOP) lowering medications before starting the study treatments. The study treatments include daily administration of 0.002% DE-117B eye drops (one drop once daily for 7 days). The study also uses 0.005% Latanoprost eye drops as an active control in the randomized portion. There is a bridging cohort and a long-term extension follow-up phase to further assess the treatments. Participants will receive their assigned eye drops and be monitored closely throughout these phases. Participants will undergo regular eye exams including IOP measurements to assess treatment effects at week 4. Visual acuity, anterior chamber angle, and corneal thickness will also be evaluated. Safety assessments will monitor for adverse events or eye conditions. The study includes washout of previous medications, detailed eligibility screening, and long-term follow-up to evaluate both efficacy and safety over time.

Researchers are evaluating the use of Direct Selective Laser Trabeculoplasty (DSLT) to reduce intraocular pressure (IOP) in adults newly diagnosed with primary open-angle glaucoma or similar early-stage glaucomatous conditions, who have not previously received treatment. This study addresses a gap in current research by focusing on treatment-naive patients, aiming to determine if DSLT can provide significant IOP reduction without the need for medications, potentially improving adherence and quality of life. The trial explores whether DSLT can offer a surgical alternative to standard medication-based care for early glaucoma management. Participants will receive the DSLT procedure, which involves applying 120 laser shots at the eye's limbus using a spot size of 400 micrometers and energy between 1.4 to 1.8 millijoules over 2.4 seconds. This procedure is designed to facilitate controlled aqueous outflow to lower IOP. The study measures the percent reduction in IOP from baseline at six months post-procedure to assess effectiveness. During the study, participants will be closely monitored to measure the change in intraocular pressure at six months after treatment. Researchers will evaluate the safety and efficacy of DSLT without the use of postoperative medications. The total involvement includes initial screening, the laser procedure, and follow-up assessments to track IOP changes and any potential side effects over the six-month period.

Researchers are evaluating the bioequivalence of two ophthalmic solutions for treating adults with chronic open-angle glaucoma or ocular hypertension affecting both eyes. This randomized, double-blind, parallel-group, two-arm, multiple-dose, multicenter study aims to compare a generic bimatoprost ophthalmic solution 0.01% with LUMIGAN® (bimatoprost ophthalmic solution) 0.01%. The study focuses on measuring the mean difference in intraocular pressure (IOP) between the two treatments at specified times during Weeks 2 and 6, while also monitoring safety through reported adverse events. Participants will be randomly assigned to receive one of the two bimatoprost solutions, with one drop instilled in both eyes every night at 10:00 pm (plus or minus 1 hour) for 42 days (6 weeks). Before treatment, subjects will undergo a screening period within 6 weeks and a washout period of 4 days to 4 weeks depending on their current medications. The study maintains a near 1:1 ratio of treatment distribution based on baseline IOP and central corneal thickness (CCT) to ensure balanced groups. During the study, participants will attend visits at Day 14 (Week 2) and Day 42 (Week 6) to measure IOP at three time points: 00:00 hour, 04:00 hours, and 08:00 hours. Researchers will also collect data on adverse events by assessing their nature, severity, and frequency to compare safety between the two treatments. The total participation period includes screening, washout, treatment for 6 weeks, and scheduled IOP assessments to monitor treatment effects and safety.

Researchers are evaluating adults with primary open angle glaucoma (POAG) who have undergone a specific type of eye surgery called ab-interno goniotomy using the C-Rex Instrument. This observational real-world study collects data on the safety and effectiveness of this surgical procedure. The study follows participants for 12 months after surgery to observe changes in eye pressure and any complications related to the device. Participants receive the goniotomy surgery with the C-Rex Instrument, a manual surgical tool designed to perform the procedure inside the eye. Data is gathered from the visit before surgery, details of the surgery itself, and multiple visits up to one year after the procedure. The study focuses on the surgical details, eye pressure measurements, use of glaucoma medications, and any device-related safety events. During the 12-month follow-up, researchers collect information on intraocular pressure (IOP), medication use, and any complications related to the device. The main outcome measured is the percentage of eyes that achieve at least a 20% reduction in IOP compared to baseline values. Participants are monitored regularly throughout the year to track these outcomes and ensure safety.

This research aims to determine if oral semaglutide can safely improve inner retinal function in adults with open-angle glaucoma. The study focuses on measuring changes in the photopic negative response of the electroretinogram over six months to evaluate treatment effects. Participants will be adults aged 45 or older who have primary open-angle glaucoma and are already receiving treatment to lower eye pressure. Participants will be randomly assigned to receive either oral semaglutide or a placebo daily for six months. The semaglutide dosing starts with 3 mg per day for the first month, increases to 7 mg per day for the second month, and then continues with 14 mg per day for the remaining four months. The placebo group will receive matching tablets on a similar schedule. The study includes five clinic visits: at baseline, and after 1, 2, 3, and 6 months. During these visits, participants will undergo tests and interviews to monitor their eye function and safety. Researchers will evaluate the main outcome by comparing the photopic negative response of the electroretinogram from the start to six months. The study will also monitor participants for any side effects and overall health throughout the trial period.

Researchers are evaluating AMDX-2011P, an intravenous drug, to detect amyloid deposits in the retinas of people with Primary Open Angle Glaucoma (POAG). This Phase 2, open-label study with masked endpoint assessment aims to understand the safety, tolerability, how the drug moves through the body, and its biological activity in affected participants. Participants will receive a single intravenous bolus injection of AMDX-2011P after initial eye examinations and retinal imaging at the study site. Following administration, safety assessments, additional retinal imaging, blood collection, and pharmacokinetic tests will be conducted. Retinal images will be evaluated by assessors who are masked to treatment details. During the study, participants will undergo eye exams and retinal imaging before and after the drug injection. Blood samples will be collected to monitor drug levels and adverse effects within eight days. The main outcome measured is the adverse event profile of AMDX-2011P during this period. The study focuses on ensuring participant safety and tracking the biological response to the drug over the short term.