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Can a new tube implant surgery outperform standard glaucoma surgery?

NCT ID NCT07755761

Disease control Sponsor: Benha University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial tests whether a new surgical procedure, called Innovative Tube Trabeculectomy, can better control eye pressure in people with advanced glaucoma that hasn't responded to other treatments. The new technique uses a deeper tunnel, a special suture, and a small tube to improve fluid drainage and reduce scarring. Participants are randomly assigned to receive either the new procedure or the standard trabeculectomy and are followed for a year to compare eye pressure, medication needs, and complications.

What this could mean

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

Active substance
Innovative Tube Trabeculectomy, a surgical procedure with a deep scleral tunnel, X-shaped suture, and nasolacrimal tube implant, plus a preoperative regimen including Mitomycin C, Avastin, and Dexamethasone
What this could lead to
If successful, this could offer a more effective surgical option for people with advanced glaucoma that hasn't responded to other treatments, potentially preserving vision with fewer complications.
What could go wrong
This is a single-center trial, and the new technique is complex. It may not prove better than the standard surgery, and there are risks of infection, bleeding, or scarring that could affect the outcome.

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 116 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Aug 2028

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- • Diagnosis of advanced or refractory primary open-angle glaucoma (POAG) or secondary open-angle glaucoma (excluding neovascular glaucoma). * Intraocular pressure (IOP) \> 21 mmHg despite maximal tolerated medical therapy or previous failed glaucoma surgery. * Best corrected visual acuity (BCVA) of 20/400 or better. * Capable of providing informed consent Exclusion Criteria: * Previous incisional glaucoma surgery in the study eye (except for prior failed trabeculectomy in the refractory group). * Neovascular glaucoma or other forms of secondary glaucoma that may significantly impact wound healing (e.g., uveitic glaucoma). * Significant ocular comorbidities that may confound outcome assessment (e.g., severe corneal disease, retinal detachment). * Pregnancy or lactation. * Participation in another clinical trial within 30 days prior to enrollment.

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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 Innovative procedures Trabeculectomy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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.

Contacts and locations

Locations

  • Ophthalmology department, Faculty of Medicine, Benha University

    RECRUITING

    Banhā, 13518, Egypt

    Contact Email: •••••@•••••

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