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Eye implant showdown: which tiny drain works best for glaucoma?

NCT ID NCT07623434

Disease control Sponsor: Military Institute od Medicine National Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared two small eye implants, Hydrus and iStent, placed during cataract surgery to help lower eye pressure in people with open-angle glaucoma. 65 patients were followed long-term to see which device worked better and was safer. The goal was to reduce the need for glaucoma medications and protect vision.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hydrus microimplant or iStent microimplant (both are tiny devices placed in the eye during cataract surgery to help drain fluid and lower eye pressure)
What this could lead to
If one device proves better, it could become the preferred option for managing glaucoma during cataract surgery, helping patients maintain vision with fewer eye drops.
What could go wrong
This is a small, completed study (65 people) comparing two existing devices, so it won't lead to a new treatment. Results may not apply to all glaucoma patients, and both devices carry surgical risks like infection or implant misplacement.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

65 people

The number who actually took part.

Started

Jan 2015

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show 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: the cataract which had a significant effect on the visual acuity of the patients and one of the following conditions: progression of glaucoma in visual field confirmed by two consecutive examinations by the Humphrey visual field analyzer with SITA Standard 24-2 algorithm in the course of primary open-angle glaucoma despite the use of IOP-lowering medications (1 to 4 active ingredients) or patients not tolerating or adhering to the treatment. Exclusion Criteria: lack of consent for study participation, narrow-angle or closed-angle glaucoma, secondary glaucoma (including the course of psudoexfoliation syndrome, pigmentary glaucoma), advanced glaucoma, severe proliferative diabetic retinopathy, cloudy cornea, advanced macular degeneration, history of glaucoma surgical interventions (as well as trabeculoplasty), and use of more than four IOP-lowering medications

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Conditions

The condition(s) this trial relates to.

glaucoma open-angle glaucoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Glaucoma

Contacts and locations

Locations

  • Military Institute of Medicine - National Research Institute

    Warsaw, Mazovian, 04-141, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.