NCT05557058Active, not recruiting
GORE Glaucoma Drainage Implant Clinical Study Dominican Republic
A Prospective, Single-Center, Early Feasibility Clinical Study Designed to Evaluate the Safety and Effectiveness of the GORE Glaucoma Drainage Implant (GORE GDI) in Subjects With Primary Open-Angle Glaucoma Uncontrolled by Hypotensive Medications or for Which Conventional Incisional Glaucoma Surgery Would be More Likely to Fail Due to Scarring
Source: ClinicalTrials.gov · Last updated 19 Feb 2026
Brief summary (registry, in English)
The objective of this early feasibility clinical study is to evaluate the safety and effectiveness of several different GORE Glaucoma Drainage Implant configurations in subjects with primary open-angle glaucoma that is uncontrolled by hypotensive medications or for which conventional incisional glaucoma surgery would be more likely to fail due to scarring.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 20 Sept 2022
- Start date
- 14 Sept 2022
- Primary completion date
- 12 Feb 2027
- Lead sponsor
- W.L.Gore & Associates
- Diseases
- Glaucoma
- NCT number
- NCT05557058
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 14 Sept 2022 to the primary completion date, 12 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Expected inability to implant the study device in the superotemporal quadrant (e.g., a lack of freely mobile conjunctiva to cover the entire implanted device in the superotemporal quadrant)
- Prior corneal transplant surgery (full or partial thickness transplants) or clinically significant corneal dystrophy, e.g., Fuchs' dystrophy (\> 12 confluent guttae) in the study eye
- Concurrent cataract surgery or anticipated need for cataract surgery (i.e., clinically significant cataract) in the study eye during the 12 months following implantation
Other illness
- Diagnosis of any active ocular disease or disorder (other than glaucoma) that requires treatment, where the disease or treatment could be reasonably expected to affect the vision or IOP during the duration of the study
Other
- BCDVA worse than 20/200 in the fellow (non-study) eye at the screening visit and BCDVA of the fellow eye cannot be worse than that of the study eye.
Who the study is looking for
- Males and females, age 18 to 85 years, inclusive at screening visit
- A diagnosis of primary open-angle glaucoma (Shaffer angle ≥ 3 as seen on gonioscopy) at screening visit
- Medicated intraocular pressure at screening visit and the mean medicated diurnal IOP at baseline visit ≥ 18 mmHg and ≤ 40 mmHg by Goldmann Applanation Tonometry
Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Laser Center Coordinator of this site? Confirm its status | Santo Domingo | Dominican Republic | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.