Releasable intraluminal suture to reduce hypotony after Preserflo glaucoma surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates a releasable intraluminal suture method used with the Preserflo glaucoma drainage device. It aims to determine safety and potential to reduce postoperative hypotony while maintaining intraocular pressure control. Eligible participants have open-angle, pseudoexfoliative, or pigmentary glaucoma requiring surgical intervention and meet criteria related to conjunctival health and prior treatment failure or risk of failure. The investigation uses a standard surgical approach with the added releasable suture technique to modulate outflow. Results will inform whether this method can improve outcomes in MIGS/LIGS contexts.

Why it matters

Who can join: the full rules

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

Where it's running

• Hôpital Privé de la Baie
  Avranches, France Recruiting

Study contacts

• Principal investigator: Ana Miguel, MD — Hôpital Privé de la Baie
• Study coordinator: Marion Mandon, PhD
• Email: mmandon@vivalto-sante.com
• Phone: +33 6 78 27 76 72

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.