The goal of this randomized controlled clinical trial is to learn whether two minimally invasive bleb-forming glaucoma implants can effectively treat adult patients with open-angle glaucoma who require surgical lowering of intraocular pressure (IOP). Specifically, the study evaluates whether the PRESERFLO™ MicroShunt is at least as effective as the XEN®-63 Gel Stent in reducing IOP after surgery. 
The main questions it aims to answer are:
* Does the PRESERFLO™ MicroShunt provide IOP reduction at 12 months that is non-inferior to the XEN®-63 Gel Stent?
* How do the two devices compare over 24 months with respect to medication reduction, need for additional glaucoma procedures, complications, and preservation of visual function and ocular structures?
Participants will:
* Be randomly assigned (1:1) to receive either the XEN®-63 Gel Stent or the PRESERFLO™ MicroShunt during a single glaucoma surgery.
* Attend scheduled follow-up visits over 24 months for eye-pressure measurements, vision testing, visual-field testing, OCT imaging, endothelial-cell counts, and safety assessments.
* Receive standard postoperative care and report any complications or additional treatments during the study period.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \>40 years of age
* An established diagnosis of: Primary open angle glaucoma, Normal tension glaucoma, Pigment dispersion glaucoma (PDG) or Pseudoexfoliative glaucoma (PEX)
* Inadequately controlled on maximum tolerated medical therapy.
* Mean Deviation (MD) \</= -3
* Intraocular pressure of 14-28 mmHg
* Endothelial Cell Count ≥1000 cells/mm2
Exclusion Criteria:
* An established diagnosis of: Closed-angle glaucoma or Secondary open-angle glaucoma (besides PDG and PEX)
* Lens status: Aphakic patients or Anterior chamber intraocular lens
* Previous procedures: Glaucoma shunt/valve/ surgery or cyclodestructive procedure, Selective laser trabeculoplasty within the past 3 months, Incisional ophthalmic surgery involving the conjunctiva within the past 3 months, Clear corneal cataract or trabecular meshwork surgery conducted within the past 6 months.
* Presence of intraocular silicone oil
* No light perception vision
* Current corticosteroid use (ocular or oral)
* Conjunctival pathologies (e.g., pterygium)
* Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)
* Vitreous present in the anterior chamber
* Active iris neovascularization or neovascularization of the iris within 6 months of the surgical date
* Unwillingness or inability to give consent, accept randomization or return for and participate in scheduled protocol visits
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.