Safety and Effectiveness of PreserFlo and XEN Stents With or Without Amniotic Membrane in Glaucoma Surgery

Sponsor
Nova Scotia Health Authority
Study ID
NCT07143708
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Glaucoma Surgery with Amniotic Membrane — OTHER
    Arm 2: Glaucoma Surgery with Amniotic Membrane Participants undergo glaucoma surgery with either a PreserFlo MicroShunt or a XEN Stent, as determined by the treating surgeon. In this group, the implanted stent is covered with an amniotic membrane patch to reduce postoperative scarring and improve long-term outcomes. Follow-up visits are scheduled as per standard of care for glaucoma surgery (up to 12 months).
  • Glaucoma Surgery without Amniotic Membrane — OTHER
    Arm 1: Glaucoma Surgery without Amniotic Membrane Participants undergo glaucoma surgery with either a PreserFlo MicroShunt or a XEN Stent, as determined by the treating surgeon. No modifications are made to the procedure. Follow-up visits are scheduled as per standard of care for glaucoma surgery (up to 12 months).

Study Details

Glaucoma is one of the leading causes of permanent blindness in the world. It happens when the optic nerve-the connection between the eye and the brain-is damaged. As this damage gets worse, vision is slowly lost. Glaucoma treatments often begin with eye drops to lower eye pressure. If drops are not enough, surgery may be needed. The type of surgery depends on how advanced the glaucoma is and how much vision has already been lost. Some glaucoma surgeries, including trabeculectomy, PreserFlo MicroShunt, and XEN Stent, create a new pathway for fluid to drain out of the eye. This helps lower pressure inside the eye. However, after surgery, the body's natural healing process can sometimes cause inflammation and scarring, which may block the new drainage pathway. If this happens, eye pressure can rise again, and the surgery may not work as well as hoped. This study is testing whether covering the PreserFlo or XEN devices with amniotic membrane (a safe tissue already used in other eye surgeries) can reduce scarring, improve healing, and lead to better long-term results. Amniotic membrane has already been used safely in many types of eye surgeries. It has been shown to improve healing and reduce scarring in some glaucoma surgeries. But it has not yet been studied in PreserFlo MicroShunt or XEN Stent procedures. The goal is to see if adding amniotic membrane makes the surgery safer and more effective for people with glaucoma.

Key Dates

First listed
Aug 27, 2025
Start date
Dec 1, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: No Amniotic Membrane Group
    Patients receive standard glaucoma surgery (PreserFlo MicroShunt or XEN Stent) without additional covering. The choice between PreserFlo or XEN is not part of the study design-it's determined beforehand by the surgeon as part of regular care.
  • Experimental: Amniotic Membrane Group
    Patients receive standard glaucoma surgery (PreserFlo MicroShunt or XEN Stent) with additional covering. The implanted MicroShunt or Stent is covered with an amniotic membrane patch. The choice between PreserFlo or XEN is not part of the study design-it's determined beforehand by the surgeon as part of regular care.

Primary Outcome Measure

Rate of adverse events [ Time Frame: Surgery (Day 0) to 12 months ]

Central Contacts

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