Graft Selection for Glaucoma Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores different patch materials used in surgery to treat glaucoma, a condition that can cause vision loss due to high eye pressure. The trial compares three materials—donor sclera, cornea, and pericardium—used with a MicroShunt (a small drainage device) to determine which best maintains the device's placement and function. Researchers will evaluate participants on outcomes like surgery success, comfort, and satisfaction. People with glaucoma who need surgery, understand the study, and can attend follow-ups might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve surgical outcomes for glaucoma patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that these graft materials are safe for use in glaucoma surgery?
Research shows that the PreserFlo MicroShunt is generally safe for treating glaucoma, a condition that damages the optic nerve, often due to high eye pressure. Studies have demonstrated that the MicroShunt effectively reduces this pressure over 12 months. The device has a low rate of complications, making it a reliable choice for patients.
The MicroShunt can be used with different types of patch grafts: corneal, pericardial, and scleral. Each type has been studied for safety. Corneal grafts have proven safe in eye surgeries, with no significant harm to eye cells over three years. Pericardial grafts are durable and have been used safely in both heart and eye surgeries. Scleral grafts are also trusted, showing low erosion rates and good long-term results.
Overall, the PreserFlo MicroShunt with these grafts is well-tolerated, with studies supporting its safety and effectiveness in lowering eye pressure without significant risks.12345Why are researchers excited about this trial?
Researchers are excited about the MicroShunt treatments for glaucoma surgery because they offer new ways to manage intraocular pressure (IOP) with potentially fewer complications. Unlike traditional glaucoma treatments that often involve medications or trabeculectomy surgery, the MicroShunt is a tiny drainage device designed to reduce IOP more predictably and with less risk of scarring. The unique aspect of this trial is the use of different patch graft materials—corneal, pericardial, and scleral—to cover the tube, which could improve the longevity and safety of the implants. These variations might offer better patient outcomes, such as reduced risk of tube erosion and infection, making them an exciting avenue for advancing glaucoma care.
What evidence suggests that this trial's treatments could be effective for glaucoma?
Research shows that the PreserFlo MicroShunt lowers eye pressure in people with glaucoma. Studies have found that this device significantly reduces eye pressure over a year, making it a promising option for those with this condition. In this trial, participants will receive the PreserFlo MicroShunt with different materials covering the device. One group will receive a donor scleral patch graft, which has shown low wear rates and good long-term results. Another group will receive a corneal patch graft, which is safe and effective due to its clarity and availability. A third group will receive a pericardial patch graft, a strong tissue used in heart surgery that has also been effective in treating glaucoma. These materials aim to improve the surgery's success and the device's lifespan while reducing issues like tube wear.12345
Are You a Good Fit for This Trial?
This trial is for individuals with glaucoma who need surgery because their eye pressure remains high despite maximum tolerated medical therapy or due to disease progression. Participants must be suitable candidates for the PRESERFLO™ MicroShunt implantation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo PreserFlo MicroShunt implantation with different patch grafts (pericardial, scleral, or corneal) and receive standard perioperative care
Follow-up
Participants are monitored for safety, effectiveness, and patient-reported outcomes after treatment
Patient-reported outcome study
Surveys to assess patient comfort and satisfaction with different grafts at key time points
What Are the Treatments Tested in This Trial?
Interventions
- MicroShunt with Corneal Patch Graft
- MicroShunt with Pericardial Patch Graft
- MicroShunt with Scleral Patch Graft
Trial Overview
The study tests three types of patch grafts used in glaucoma surgery: donor sclera, cornea, and pericardium. It aims to compare surgical success rates, complications like low eye pressure after surgery, tube erosion, conjunctival issues, infections, and device longevity.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Participants undergo PreserFlo MicroShunt implantation with a pericardial patch graft covering the tube. Standard perioperative care and identical follow-up schedule. Outcomes as above: IOP control, complication profile, reoperations, longevity, patient-reported outcomes, and resource use. Primary and revision cases are included per stratified randomization.
Participants undergo PreserFlo MicroShunt implantation with a donor scleral patch graft covering the tube. Standard perioperative care (e.g., MMC/5-FU per site protocol) and scheduled follow-up (day 1; week 1-2; months 1, 3, 6, 9, 12). Outcomes include IOP, hypotony, tube erosion, conjunctival complications, infection, reoperations, device longevity, patient-reported comfort/cosmesis, and resource use. Primary and revision cases are included per stratified randomization.
Participants undergo PreserFlo MicroShunt implantation with a donor corneal patch graft covering the tube. Standard perioperative care and identical follow-up schedule. Outcomes as above: IOP control, complications (including erosion and hypotony), reoperations, longevity, patient-reported outcomes, and resource use. Primary and revision cases are included per stratified randomization.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alberta
Lead Sponsor
Citations
Optimizing Graft Selection in Glaucoma Surgery: A ...
Outcomes of interest will include surgical success rates, post-operative hypotony, tube erosion, conjunctival complications, infection, and ...
3-year real-world outcomes of standalone PreserFlo ...
No statistically significant reduction in endothelial cell density (ECD) was observed 3 years after microshunt implantation (n = 13; p = 0.526).
Long-Term Outcomes of the PRESERFLO MicroShunt ...
The Preserflo MicroShunt achieved a noticeable reduction in IOP over the course of 12 months in glaucoma patients, irrespective of disease severity or disease ...
Clinical Outcomes and Cost Analysis of PreserFlo versus ...
A total of 134 consecutive eyes of 129 patients (70 undergoing MicroShunt, 64 trabeculectomy). Methods. Primary and secondary glaucoma cases ...
5.
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cos-sco.secure-platform.com/site/solicitations/102001/sessiongallery/94002/application/4639Canadian Ophthalmological Society - Proposal - OpenWater
In 27 eyes a scleral or corneal patch graft was placed with a ripcord. The efficacy was evaluated by reduction of intraocular pressure (IOP) and glaucoma ...
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