Status:
NOT_YET_RECRUITING
Safety and Effectiveness of PreserFlo and XEN Stents With or Without Amniotic Membrane in Glaucoma Surgery
Lead Sponsor:
Nova Scotia Health Authority
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Glaucoma is the leading cause of permanent blindness worldwide. Glaucoma is damage to the optic nerve, which sends information from the eye to the brain. This damage causes vision to weaken. Treatment...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Unwilling or unable to give consent
- Unable to come for scheduled post-operative visits
- Pregnant or nursing women
- Previous cyclodestructive procedures, scleral buckling procedures, or presence of silicone oil
- Conjunctival scarring precluding a glaucoma surgery superiorly
- Active iris neovascularization or active proliferative retinopathy
- Vitreous in the anterior chamber for which a vitrectomy is anticipated.
- Previous trabeculectomy, tube-shunt implantation, or surgeries that shunt aqueous outflow into the subconjunctival space
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT07143708
Start Date
December 1 2025
End Date
December 31 2027
Last Update
August 27 2025
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