Evaluation of minimal invasive surgery options for glaucoma
Evaluation of Minimal Invasive Glaucoma Surgery: Trabeculectomy vs. XEN ® vs. Preserflo ®. Randomized Clinial Trial
This study is testing three different types of surgery for glaucoma to see which one works best for patients over five years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 1 site (Graz) |
| Trial ID | NCT04572880 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the outcomes of three different surgical approaches for treating glaucoma: trabeculectomy, Preserflo®, and XEN®. A total of 150 patients will be randomly assigned to one of these surgical interventions, and their progress will be monitored over a five-year period. Key assessments will include intraocular pressure, visual acuity, and quality of life, among others, to determine the effectiveness and safety of each surgical method. The study seeks to provide valuable data on postoperative outcomes and improve treatment strategies for glaucoma patients.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with glaucoma who require surgery to achieve their target intraocular pressure.
Not a fit: Patients with specific types of glaucoma such as angle closure or those who have had prior filtering surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical options for glaucoma patients, enhancing their quality of life and preserving vision.
How similar studies have performed: Previous studies have shown promise in minimal invasive glaucoma surgery approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patiens with glaucoma in which surgery is indicated to reach target intraocular pressure * Subjects not anticipated to require any further surgery in the next 12 months Exclusion Criteria: * Patients who do not want to make follow-ups at the department * angle closure, uveitic, neovascular, congenital glaucoma, iridocorneal endothelial syndrom, Axenfeld-Rieger syndrom. * Prior filtering glaucoma surgery, suprachoroidal stent, retinal surgery, corneal graft surgery or cyclophotocoagulation * Any major ocular inflammation up to 30 days prior to surgery * Conjunctival scarring * Allergy to any drugs required for the protocol
Where this trial is running
Graz
- Medical University of Graz — Graz, Austria (Recruiting)
Study contacts
- Study coordinator: Ewald Lindner, PD Dr.
- Email: ewald.lindner@medunigraz.at
- Phone: +43316385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.