Sustained Release Bimatoprost Implant for Ocular Hypertension and Open-Angle Glaucoma
This study aims to evaluate the effectiveness and safety of a sustained release bimatoprost implant in adults with ocular hypertension and open-angle glaucoma.
Bimatoprost Implant System / IOL Combination
Cataract+2
+ Eye Diseases
+ Glaucoma
Treatment Study
Summary
Study start date: April 21, 2022
Actual date on which the first participant was enrolled.This study aims to evaluate the safety and effectiveness of a new implant system for individuals with ocular hypertension or mild to moderate open-angle glaucoma. Ocular hypertension and open-angle glaucoma are conditions that can lead to increased pressure inside the eye, potentially damaging the optic nerve and affecting vision. The study investigates the use of the SpyGlass Bimatoprost Implant System combined with an intraocular lens (IOL) in patients undergoing cataract surgery. It explores how different doses of the implant might help in managing eye pressure, offering potential new solutions for these common eye conditions. Participants in this study undergo cataract surgery followed by the implantation of the SpyGlass Bimatoprost Implant System. This implant is provided in three different dose levels: low, medium, and high. The study spans six months, during which participants attend several follow-up visits to monitor their eye health and measure intraocular pressure (IOP). The IOP is assessed using a unique method involving two observers to ensure accuracy. While the study does not involve blinding, meaning participants and doctors know the treatment being given, the careful measurement technique ensures precise evaluation of the implant's effectiveness in controlling eye pressure.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.24 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 22 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Centro Oftalmológico Robles
Santa Rosa de Copán, HondurasOpen Centro Oftalmológico Robles in Google Maps