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Compares treatment options for GLAUCOMA 1, OPEN ANGLE, D (Disorder)
Official title Preserflo MicroShunt Versus Trabeculectomy
ClinicalTrials.gov ID: NCT07496957
What this study is testing
- What it's testing
- 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 trabeculectomy in reducing IOP after surgery.
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- -\>21 years of age
- An established diagnosis of: Primary open angle glaucoma, Normal tension glaucoma, Pigment dispersion glaucoma (PDG) or Pseudoexfoliative glaucoma...
- Inadequately controlled on maximum tolerated medical therapy
- Mean Deviation (MD) \</= -3
- Intraocular pressure of 14-28 mmHg
You likely can't join if
- 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...
- Presence of intraocular silicone oil
- No light perception vision
- Current corticosteroid use (ocular or oral)
See the full eligibility criteria
- -\>21 years of age
- An established diagnosis of: Primary open angle glaucoma, Normal tension glaucoma, Pigment dispersion glaucoma (PDG) or Pseudoexfoliative glaucoma (PEXG)
- Inadequately controlled on maximum tolerated medical therapy
- Mean Deviation (MD) \</= -3
- Intraocular pressure of 14-28 mmHg
- Endothelial Cell Count ≥1000 cells/mm2
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bialystok, Polska, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bialystok, Polska, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.