BridgeMD
Compares treatment options for Primary Open Angle Glaucoma
Official title XEN Glaucoma Gel Stent Versus Trabeculectomy
ClinicalTrials.gov ID: NCT05439161
What this study is testing
- What it's testing
- Multicentric evaluation of best corrected visual acuity of the XEN implant versus classic trabeculectomy in open angle glaucoma subjects
- 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 18 and older
You may be able to join if
- Diagnosis of open angle glaucoma (Primary open angle glaucoma, Pseudoexfoliation glaucoma, Pigmentary dispersion glaucoma)
- Clinically eligible for both surgeries (Trabeculectomy and XEN) on the discretion of the surgeon (area of healthy, free and mobile conjunctiva in the...
- VA logMAR ≤ 1 (VA dec ≥ 0.1)
- Trabecular meshwork must be visible (with Shaffer angle grade \> 1 in the target quadrant)
- Age 18 years or older
You likely can't join if
- Clinical significant cataract
- Subject has had prior cataract surgery in study eye ≤ 1 months (count to operation)
- Subject has had prior (incisional) glaucoma surgery (XEN, trabeculectomy, viscocanalostomy, canaloplasty, shunts of any type, collagen implants...
- Phacic Angle Closure Glaucoma
- Subject has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
- Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)
See the full eligibility criteria
- Diagnosis of open angle glaucoma (Primary open angle glaucoma, Pseudoexfoliation glaucoma, Pigmentary dispersion glaucoma)
- Clinically eligible for both surgeries (Trabeculectomy and XEN) on the discretion of the surgeon (area of healthy, free and mobile conjunctiva in the superior nasal target quadrant)
- VA logMAR ≤ 1 (VA dec ≥ 0.1)
- Trabecular meshwork must be visible (with Shaffer angle grade \> 1 in the target quadrant)
- Age 18 years or older
- Patient understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written informed consent
- Clinical significant cataract
- Subject has had prior cataract surgery in study eye ≤ 1 months (count to operation)
- Subject has had prior (incisional) glaucoma surgery (XEN, trabeculectomy, viscocanalostomy, canaloplasty, shunts of any type, collagen implants, etc.). Prior iridotomy is acceptable.
- Phacic Angle Closure Glaucoma
- Subject has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
- Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)
- Anterior chamber intraocular lens
- Vitreous present in the anterior chamber
- Presence of intraocular silicone oil
- History of corneal surgery, corneal opacities, or corneal disease
- Impaired episcleral venous drainage (e.g. Sturge-Weber or nanophthalmos)
- History of dermatologic keloid formation
- Active diabetic retinopathy, proliferative retinopathy, choroidal neovascularization, branch retinal vein occlusion, central retinal vein occlusion, or other ophthalmic disease or disorder that could confound study...
- Known or suspected allergy or sensitivity to drugs required for the surgical procedure or any of the device components (e.g., porcine products or glutaraldehyde),
- Pregnant or nursing women
The study team makes the final eligibility decision.
Where it's taking place
- Salzburg, Austria
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salzburg, Austria. 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.