MedTrace Logo

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

NCT07143708 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2025-08-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Glaucoma Surgery with Amniotic Membrane

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).

OTHER

Glaucoma Surgery without Amniotic Membrane

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).

Sponsors & Collaborators

  • Nova Scotia Health Authority

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2027-12-31
Completion
2027-12-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07143708 on ClinicalTrials.gov