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GORE Glaucoma Drainage Implant Clinical Study Dominican Republic

NCT05557058 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-19

No results posted yet for this study

Summary

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.

Conditions

  • Primary Open-angle Glaucoma

Interventions

DEVICE

Gore Glaucoma Device Implant (GORE GDI)

Unilateral implantation of one of three different configurations of the GORE GDI

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Juan F Batlle Pichardo, M.D. · Laser Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-14
Primary Completion
2027-02-12
Completion
2031-08-31

Countries

  • Dominican Republic

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05557058 on ClinicalTrials.gov