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

ConditionGlaucoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNova Scotia Health Authority

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Glaucoma Surgery with Amniotic Membrane
  • Glaucoma Surgery without Amniotic Membrane

Treatment groups

156 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators