New stitch technique aims to prevent dangerous low eye pressure after glaucoma surgery
NCT ID NCT07531199
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether placing a temporary stitch inside a tiny drainage device (Preserflo) can reduce the risk of dangerously low eye pressure after glaucoma surgery. The device is already used in France to lower eye pressure, but low pressure can still happen. About 192 adults with glaucoma will be randomly assigned to get the stitch or not, and doctors will compare how often low pressure occurs.
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
-
About 192 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
May 2026
An estimate. Start dates often move.
- Expected to finish
-
Feb 2029
An estimate. End dates often move.
- 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 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: * Primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma with an indication for glaucoma surgery (defined as uncontrolled intraocular pressure or worsening of visual fields, despite maximum tolerated medical therapy) and an open iridocorneal angle (trabeculum visible on gonioscopy, Shaffer classification grade 3-4) * Healthy, mobile conjunctiva (without scarring or adhesions). * The indication for glaucoma surgery is defined as uncontrolled IOP or worsening of visual fields despite maximum tolerated medical therapy, and with either a previous failure of trabeculectomy or a risk of failure. * Maximum tolerated medical therapy: 3 or more classes of ocular hypotensive treatment, or fewer if there is an allergy or intolerance to the treatment. Visual field defects must be more severe than -3 dB in mean deviation. Exclusion Criteria: * severe systemic pathologies * other ophtalmic pathologies (except cataract) * previous intraocular surgery (except cataract) * neovascular glaucoma or iris neovascularization * pachymetry \< 490µm or \> 620µm * contraindication to PRESERFLO Microshunt
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Glaucoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can exercise shield the eyes of glaucoma patients?
- One operation for cataract and glaucoma? eye surgeons test a Two-in-One approach
- Can better Follow-Up schedules save sight in glaucoma?
- Portable devices could take the guesswork out of eye pressure checks
- Eye drops may shield the cornea after cataract surgery
- Can a puff of air replace the eye pressure probe?