Ocular Hypertension

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 the safety and effectiveness of a drug called TFC-003 in adults diagnosed with primary open-angle glaucoma or ocular hypertension. This phase 3 study aims to compare TFC-003 with other similar drug formulations to understand their impact on eye pressure, which is critical in managing these eye conditions. Participants will receive one of three treatments TFC-003 administered twice daily as eye drops, TFC-003-R1 also given twice daily, or a combination of two eye drops, TFC-003-R2 and TFC-003-R3, both given twice daily with at least a 10-minute gap between them. The treatments are given approximately at 830 AM and 830 PM each day. Each participant will be randomly assigned to one of these treatment groups in a parallel study design. During the study, participants will have their intraocular pressure measured at the start and at weekly intervals up to 24 weeks. The main outcome is the change in eye pressure over 12 weeks, with additional assessments extending to 24 weeks. Participants will be monitored closely through scheduled visits to ensure adherence to the treatment and to evaluate safety and effectiveness throughout the study period.

Many young children find visual field VF testing of peripheral vision difficult and not engaging, which leads to poor attention and unreliable test results. This issue causes challenges in diagnosing and monitoring eye conditions like glaucoma and optic nerve abnormalities in children. The study aims to develop a new device that makes VF testing more enjoyable and improves the consistency of childrens responses, potentially enhancing the accuracy of peripheral vision assessments in pediatric patients. The study compares two approaches during Humphrey perimetry testing one using a new device featuring a small video screen that shows popular cartoon characters as a fixation target along with audio instructions voiced as cartoon characters, and the other using the usual care procedures without these enhancements. Children participate in two study visits about a week apart to complete the tests under these different conditions. Participants will undergo Humphrey Visual Field tests during both visits to measure the consistency of their responses and reliability of the test results. Researchers will assess variability in mean deviation scores and other reliability indices to determine if the cartoon-based device improves test accuracy. The study lasts about one week between visits, with continued monitoring of test reliability and participant engagement throughout this period.

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 comparing two devices used for optical coherence tomography OCT, a noninvasive scanning method that uses reflected light to create images of the back of the eye. This technique helps doctors detect and monitor different types of ocular tumors. The study is led by Memorial Sloan Kettering Cancer Center and focuses on people with at least one eye affected by an intraocular or ocular surface tumor. The study evaluates the Intalight Dream OCT, a next-generation swept-source device with faster imaging speed and higher sensitivity, against the Heidelberg Spectralis OCT, which is the current standard of care for optical imaging. Participants will undergo imaging using both devices to compare image quality and field of view over a period of up to one year. Participants will be assessed for image quality and field of view during the study. To be part of the study, they must have pupils that can dilate adequately and be able to sit still and fixate on the imaging target during the procedure, which takes approximately 2 minutes. The study enrollment begins in February 2026 and continues until February 2028, with ongoing monitoring of imaging results throughout this period.

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.

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.