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 program's 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 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 eye's 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.

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 children's 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 eye's 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 DSLT's 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 10:00 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 00:00, 04:00, and 08:00 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 adults with primary open angle glaucoma (POAG) who have undergone goniotomy surgery using the C-Rex Instrument. This observational real-world evidence study focuses on understanding surgical outcomes, including changes in intraocular pressure (IOP), medication use, and any complications related to the device. The study is conducted at multiple centers and follows patients who had this specific IOP-lowering surgery. Participants receive ab interno goniotomy surgery with the C-Rex Instrument either combined with cataract extraction and intraocular lens implantation or as a standalone procedure. Data collection includes details from the preoperative visit before surgery, the surgical procedure itself, and follow-up visits up to 12 months after surgery. This allows for monitoring of surgical effects and device-related safety. During the 12-month follow-up, researchers gather information on IOP levels compared to baseline, use of glaucoma medications, and any device-related complications. The main outcome measured is the percentage of eyes showing at least a 20% reduction in IOP at 12 months after surgery. This ongoing monitoring helps assess the surgical procedure's impact and safety over time.

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 mg/day for the first month, increases to 7 mg/day for the second month, then continues at 14 mg/day 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.

Researchers are studying AMDX-2011P to see if it can detect amyloid deposits in the retina of people with Primary Open Angle Glaucoma (POAG). This Phase 2, open-label study will assess the safety, tolerability, plasma pharmacokinetics, and biological activity of AMDX-2011P given intravenously. Retinal images will be evaluated by masked assessors to ensure unbiased analysis. Participants will receive a single intravenous bolus injection of AMDX-2011P at either 50 mg or 100 mg dose. Before the injection, eye exams and retinal imaging are performed. After administration, safety checks, retinal imaging, blood collection, and pharmacokinetic assessments will be conducted to monitor the drug's behavior in the body. During the study, participants will undergo eye examinations and retinal imaging to record baseline and post-injection changes. Blood samples will be collected for pharmacokinetic analysis within 2 hours after dosing. Safety will be monitored for 8 days following the injection, focusing on any adverse events. Biological activity will also be assessed within one day. The total participation time includes initial assessments and follow-up safety monitoring.

This research aims to assess the safety of the Helix Surgical System when used alongside cataract surgery and to gather early evidence on its effectiveness in lowering intraocular pressure (IOP) in people with mild to moderate primary open-angle glaucoma (POAG) and cataracts. The study focuses on individuals diagnosed with these eye conditions to better understand the potential benefits and risks of this device. The Helix Surgical System is a handheld device designed to improve eye fluid drainage by viscodilating up to 360 degrees of Schlemm's canal and collector channels, and it also allows an intracanalicular scaffolding procedure to restore the eye's aqueous outflow system. Participants will undergo cataract surgery combined with the use of this system to evaluate its impact on IOP and medication use. Participants will be monitored over time with assessments including measurement of intraocular pressure at three months after surgery to determine if there is at least a 20% change from baseline. Researchers will also track changes in the average number of ocular hypotensive medications used. Safety and effectiveness will be evaluated through regular check-ups and eye exams during the study period, which is expected to last several months after the procedure.