Open-Angle Glaucoma

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.

Researchers are evaluating the 24-hour effect on intraocular pressure IOP reduction of a fixed combination of netarsudil and latanoprost compared to latanoprost alone in adults aged 18 years and older with open angle glaucoma or ocular hypertension. This study is a phase 4, double-masked, paired-contralateral trial aimed at understanding how these treatments compare when applied in each eye of the same subject. Participants will receive netarsudil-latanoprost fixed combination eye drops in one eye and latanoprost eye drops in the other eye, each dosed once daily at night for 14 consecutive days. The total participation time may extend up to 10 weeks to include any necessary washout from prior treatments. This design allows direct comparison of the two treatments within the same individual. During the study, participants will undergo various eye examinations including visual field testing, optical coherence tomography, and dilated fundus exams to assess IOP changes. Researchers will monitor IOP changes over 24 hours, focusing on mean IOP reduction, nighttime and daytime IOP variations after two weeks of treatment. Safety and adherence will be tracked throughout, with total study involvement lasting up to 10 weeks including screening and washout periods.

Researchers are evaluating a preservative-free version of Bimatoprost ophthalmic solution 0.01% YSBP compared to Lumigan4 bimatoprost ophthalmic solution 0.01% in adults with primary open-angle glaucoma POAG or ocular hypertension OH. The study aims to determine if the preservative-free formulation is not worse than the existing treatment in controlling these eye conditions. This is a Phase 3 clinical trial sponsored by YS Life Science Co., Ltd., focused on treatment effectiveness and safety. Participants are randomly assigned to receive either the preservative-free Bimatoprost YSBP or Lumigan4 eye drops. The treatments are administered as eye drops, and the study uses a parallel design with two groups treated simultaneously. The trial is double-masked, meaning neither participants nor investigators know which treatment is given. The primary treatment period lasts 12 weeks, during which intraocular pressure IOP is closely monitored. During the study, participants undergo regular assessments including IOP measurements at baseline and Week 12. Visual acuity is also evaluated to ensure participants meet vision criteria. The study monitors adherence to the treatment and any side effects. The main outcome measured is the change in intraocular pressure at Week 12 to assess the treatments effect on eye pressure control. The total study duration extends through the treatment period and concludes by December 2027.

This research aims to evaluate the use of Direct Selective Laser Trabeculoplasty DSLT in adults newly diagnosed with primary open-angle glaucoma or similar conditions such as ocular hypertension. The study focuses on untreated patients to understand how well DSLT reduces intraocular pressure IOP without requiring medications. It addresses the current need for alternatives to medications, which can be difficult to use due to side effects and adherence challenges. Participants will receive the DSLT procedure, which involves delivering 120 laser shots at the eyes limbus over 2.4 seconds to help control aqueous fluid outflow and lower IOP. The study measures the reduction in IOP at 1, 3, and 6 months, with the primary goal of achieving more than a 20% decrease without medications. Only patients with baseline IOPs above 21 mmHg and no prior glaucoma treatments will be included. During the study, participants will undergo regular eye pressure assessments to track treatment effects and determine the need for additional interventions. Researchers will monitor the percentage of eyes reaching the target IOP reduction and record any secondary treatments required. The total follow-up period for assessing outcomes is 6 months, ensuring a clear understanding of DSLTs impact on early-stage glaucoma management.

Researchers are evaluating the bioequivalence of two eye drop treatments for adults with chronic open-angle glaucoma or ocular hypertension in both eyes. This randomized, double-blind, parallel-group clinical trial aims to compare a generic bimatoprost ophthalmic solution 0.01% with the branded LUMIGAN4 bimatoprost ophthalmic solution 0.01%. The study focuses on measuring changes in intraocular pressure IOP at specific times after dosing and monitoring safety through adverse event reports. Participants will be randomly assigned to receive either the test product or the reference product, each administered as one drop in both eyes every night at 1000 pm plus or minus one hour for 42 days 6 weeks. Before starting treatment, subjects will undergo a washout period of 4 days to 4 weeks depending on their prior medications. The treatment groups will have nearly equal numbers of participants based on baseline IOP and corneal thickness measurements. During the study, participants will have their IOP measured at 0000, 0400, and 0800 hours on Day 14 and Day 42 visits. Researchers will monitor safety by recording and analyzing any adverse events throughout the 6-week treatment period. The total participation includes screening, washout, treatment administration, and safety monitoring to assess the similarity and tolerability of the two bimatoprost eye drops.

Researchers are evaluating the safety, usability, implantation accuracy, and effectiveness of the MINIject S device in adults with open angle glaucoma. This study involves multiple centers across several countries and includes a first-in-man phase to identify the best insertion tool for the device. The trial also assesses the chosen tool in patients who have both glaucoma and operable cataracts undergoing combined surgery. The study is divided into two parts. Part 1 compares three different versions of the insertion tool to implant the MINIject S device into the supraciliary space, with participants and evaluators unaware of which tool is used. Part 2 expands the study to a larger group using the selected insertion tool during combined glaucoma and cataract surgery with intraocular lens implantation. Each participant receives one version of the investigational device. Participants will undergo assessments including checking device placement accuracy one week after surgery and evaluating ease of use during the procedure. Additional follow-up visits at 6, 12, and 24 months will measure changes in visual acuity, intraocular pressure, medication use, endothelial cell density, and rates of secondary surgeries and adverse events. Participants must be able to follow study instructions and attend scheduled visits. The study lasts until July 2028, with primary outcome data expected by August 2026.

Researchers are evaluating whether oral semaglutide can improve inner retinal function in people with open-angle glaucoma, a common eye condition. The study aims to find out if semaglutide safely enhances the photopic negative response measured by an electroretinogram. Participants will be compared between those taking semaglutide and those taking a placebo, a look-alike pill without the drug. Participants will take oral semaglutide or a placebo daily for six months. The semaglutide dosing starts at 3 mgday for the first month, increases to 7 mgday for the second month, then continues at 14 mgday for the remaining four months. The placebo group will take matching pills on the same schedule. The study involves five clinic visits at the start, and after 1, 2, 3, and 6 months. During these visits, participants will undergo tests including the electroretinogram, contrast sensitivity tests, and assessments of health-related quality of life. Researchers will also monitor treatment-related adverse events over the six months. The main outcome is the change in the electroretinogram response after six months compared to baseline. The total participation time lasts six months with regular monitoring.

Glaucoma is a leading cause of blindness worldwide, second only to cataracts. This research evaluates the safety and effectiveness of the XEN63 gel stent implanted using two different surgical methods ab interno inside the eye and ab externo outside the eye. The study focuses on patients with glaucoma that is not controlled by medication or previous surgery, assessing adverse events and intraocular pressure over time. Participants will be assigned to one of two groups. One group will receive the XEN63 gel stent implanted via the ab interno approach, while the other group will have it implanted via the ab externo approach. The implantation happens on Day 1, and participants will be followed for 12 months to monitor outcomes. During the study, participants will attend regular visits at hospitals or clinics to assess safety and the stents effect on glaucoma. Medical assessments and eye examinations will be conducted to measure intraocular pressure and monitor adverse events. The primary outcomes include the proportion of participants achieving a significant reduction in intraocular pressure and the number experiencing adverse events over the 12-month period.

This trial investigates the effects of three microinvasive glaucoma surgeries combined with cataract surgery in patients with mild to moderate open-angle glaucoma. The study aims to compare how well the Hydrus Microstent, incisional goniotomy, and excisional goniotomy lower eye pressure and their safety profiles. Participants will be randomly assigned to one of these three surgical options during cataract surgery to evaluate their outcomes. Participants will receive one of three procedures during cataract surgery insertion of the Hydrus Microstent into the canal of Schlemm, incisional goniotomy using a Sinskey hook to open the trabecular meshwork, or excisional goniotomy using a Kahook Dual Blade to remove part of the trabecular meshwork. These procedures are all done at the time of cataract surgery, and the study compares these different approaches to glaucoma surgery. During the study, participants will be monitored for up to three years. Researchers will measure intraocular pressure and the use of pressure-lowering medications over this time. They will also track any surgical complications. Participants must be able to attend all postoperative visits as scheduled to allow follow-up assessments. The study ensures thorough monitoring of both the effectiveness and safety of each surgical method over the long term.

Researchers are studying the use of adaptive optics AO retinal imaging to collect and analyze detailed retinal images from both healthy individuals and those with primary open angle glaucoma POAG. The goal is to support projects that improve the clinical application of AO technology by assessing cellular changes related to glaucoma. This interventional study involves 100 healthy volunteers and 50 patients with POAG. Participants will undergo imaging using investigational AO systems that combine scanning laser ophthalmoscopy SLO and optical coherence tomography OCT to capture high-resolution videos of retinal structures. Different study groups include glaucoma patients and healthy controls, some of whom will experience an oxygen inhalation challenge or visible light stimulation during imaging. Imaging is performed at several macular locations without or with interventions depending on the group. During the study, participants will have AO imaging sessions where various retinal features such as retinal blood flow, retinal ganglion cell density and size, retinal pigment epithelium organelle movement, and photoreceptor function will be measured. Some outcomes involve repeated assessments over months to evaluate reproducibility. The study includes a single imaging visit with no long-term treatment, focusing on detailed image analysis to understand glaucoma-related changes. The total duration spans from screening through the imaging sessions and follow-up measurements as specified.