Efficacy and Safety of a Releasable Intraluminal Suture Technique to Reduce Hypotony Following Gl… (NCT07531199) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy and Safety of a Releasable Intraluminal Suture Technique to Reduce Hypotony Following Glaucoma Surgery Using the Preserflo Device
192 participantsStarted 2026-05-01
Plain-language summary
Glaucoma is a common and irreversible disease of the optic nerve. It is the second leading cause of blindness worldwide. Glaucoma can be treated with medication, laser therapy, or surgery; the latter is often necessary. Traditional surgeries are invasive and carry a high rate of complications (hypotony, endophthalmitis, cataracts, etc.). Consequently, several types of micro-invasive surgeries (MIGS) and less invasive but effective surgeries, LIGS, have been developed to reduce surgical risks while maintaining effectiveness in lowering intraocular pressure (IOP). PRESERFLO is a drainage system less than 1 mm thick that regulates the outflow of aqueous humor from the eye. It is made of a soft, flexible biomaterial that conforms to the curvature of the eye. This biomaterial does not trigger a negative immune response. PRESERFLO is an example of a recently developed, powerful LIGS procedure (with preliminary results demonstrating efficacy and safety). PRESERFLO is already in use in France (marketing authorization and CE marking obtained) and is covered by social security.
This technique is highly effective in lowering IOP, but it may be associated with hypotony, although less frequently than with trabeculectomy. The use of a releasable suture placed inside the Preserflo to limit drainage and, consequently, reduce the risk of hypotony has been described with good results in preliminary studies. Nevertheless, it is necessary to evaluate the efficacy and safety of this technical modification in a randomized, prospective clinical trial to better understand whether this modification is beneficial for improving the treatment of patients with glaucoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.