New implant offers hope for glaucoma patients failing drops
NCT ID NCT05557058
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests a new device called the GORE Glaucoma Drainage Implant in 30 adults with primary open-angle glaucoma that eye drops cannot control or who are at high risk of scarring from standard surgery. The goal is to see if the implant safely lowers eye pressure by at least 20% at 6 months while using the same or fewer eye drops. This is not a cure, but aims to better manage the disease and reduce the need for daily medications.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2022
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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 * 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 * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Laser Center
Santo Domingo, Dominican Republic
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Home Eye-Pressure checks could slow glaucoma vision loss
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- Can a One-Time gene edit stop glaucoma in its tracks?
- Zapping the brain to steady the steps of glaucoma patients?
- Can a tiny eye implant replace glaucoma drops?