NCT07143708Not yet recruiting
Safety and Effectiveness of PreserFlo and XEN Stents With or Without Amniotic Membrane in Glaucoma Surgery
Comparison of the Safety and Efficacy of PreserFlo MicroShunt and XEN Stent Alone Versus With Amniotic Membrane in Glaucoma Surgery
Source: ClinicalTrials.gov · Last updated 27 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 156 (estimated)
- First submitted
- 20 Aug 2025
- Start date
- 1 Dec 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Nova Scotia Health Authority
- Diseases
- Glaucoma
- NCT number
- NCT07143708
What you commit to
- Study type: Interventional
- Planned participants: 156
- From 1 Dec 2025 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous cyclodestructive procedures, scleral buckling procedures, or presence of silicone oil
- Conjunctival scarring precluding a glaucoma surgery superiorly
- Previous trabeculectomy, tube-shunt implantation, or surgeries that shunt aqueous outflow into the subconjunctival space
Other
- Unwilling or unable to give consent
- Unable to come for scheduled post-operative visits
- Pregnant or nursing women
- Active iris neovascularization or active proliferative retinopathy
- Vitreous in the anterior chamber for which a vitrectomy is anticipated.
Who the study is looking for
- Age 18 years and older
- Patients selected for PreserFlo microshunt surgery and XEN stent alone or in combination with cataract surgery.
- Ability to comprehend the study procedures
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.