RECRUITINGINTERVENTIONAL
XEN Glaucoma Gel Stent Versus Trabeculectomy
Multicentric Evaluation of Best Corrected Visual Acuity of the XEN Implant Versus Classic Trabeculectomy in Open Angle Glaucoma Subjects
About This Trial
Multicentric evaluation of best corrected visual acuity of the XEN implant versus classic trabeculectomy in open angle glaucoma subjects
Who May Be Eligible (Plain English)
Who May Qualify:
1. Diagnosis of open angle glaucoma (Primary open angle glaucoma, Pseudoexfoliation glaucoma, Pigmentary dispersion glaucoma)
2. 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)
3. VA logMAR ≤ 1 (VA dec ≥ 0.1)
4. Trabecular meshwork must be visible (with Shaffer angle grade \> 1 in the target quadrant)
5. Age 18 years or older
6. Patient understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written willing to sign a consent form
Who Should NOT Join This Trial:
1. Clinical significant cataract
2. Subject has had prior cataract surgery in study eye ≤ 1 months (count to operation)
3. Subject has had prior (incisional) glaucoma surgery (XEN, trabeculectomy, viscocanalostomy, canaloplasty, shunts of any type, collagen implants, etc.). Prior iridotomy is acceptable.
4. Phacic Angle Closure Glaucoma
5. Subject has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
6. Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)
7. Anterior chamber intraocular lens
8. Vitreous present in the anterior chamber
9. Presence of intraocular silicone oil
10. History of corneal surgery, corneal opacities, or corneal disease
11. Impaired episcleral venous drainage (e.g. Sturge-Weber or nanophthalmos)
12. History of dermatologic keloid formation
13. 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 results
14. 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),
15. Pregnant or nursing women
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. Diagnosis of open angle glaucoma (Primary open angle glaucoma, Pseudoexfoliation glaucoma, Pigmentary dispersion glaucoma)
2. 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)
3. VA logMAR ≤ 1 (VA dec ≥ 0.1)
4. Trabecular meshwork must be visible (with Shaffer angle grade \> 1 in the target quadrant)
5. Age 18 years or older
6. Patient understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written informed consent
Exclusion Criteria:
1. Clinical significant cataract
2. Subject has had prior cataract surgery in study eye ≤ 1 months (count to operation)
3. Subject has had prior (incisional) glaucoma surgery (XEN, trabeculectomy, viscocanalostomy, canaloplasty, shunts of any type, collagen implants, etc.). Prior iridotomy is acceptable.
4. Phacic Angle Closure Glaucoma
5. Subject has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
6. Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)
7. Anterior chamber intraocular lens
8. Vitreous present in the anterior chamber
9. Presence of intraocular silicone oil
10. History of corneal surgery, corneal opacities, or corneal disease
11. Impaired episcleral venous drainage (e.g. Sturge-Weber or nanophthalmos)
12. History of dermatologic keloid formation
13. 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 results
14. 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),
15. Pregnant or nursing women
Treatments Being Tested
DEVICE
surgery
2 types of filtering glaucoma surgeries (classic trabeculectomy as gold standard, and newer XEN glaucoma microstent) are compared against each other in a prospective multicentric randomized study
Locations (1)
Dept. Ophthalmology and Optometry Paracelsus Medical University
Salzburg, Austria