Comparing two methods of glaucoma drainage device implantation in patients with prior cataract surgery
Endothelial Cell Loss in Pseudophakic Patients Receiving a Paul Glaucoma Drainage Device With Its Tube Inserted in the Anterior Versus Posterior Chamber: a Randomized Controlled Trial
This study is testing whether placing a glaucoma drainage device tube in the front or back of the eye works better for people who have had cataract surgery and have glaucoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Oogziekenhuis Rotterdam Academic / other |
| Locations | 1 site (Rotterdam) |
| Trial ID | NCT05500469 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of tube placement in either the anterior or posterior chamber during the implantation of a Paul glaucoma drainage device (GDD) in pseudophakic patients with various types of glaucoma. The primary objective is to assess the loss of corneal endothelial cells associated with each placement method, while secondary objectives include evaluating the efficacy and safety of both approaches. Participants will be randomly assigned to receive the GDD with the tube positioned in one of the two chambers, allowing for a direct comparison of outcomes. The study aims to provide insights into optimizing surgical techniques for better patient outcomes in glaucoma management.
Who should consider this trial
Good fit: Ideal candidates are pseudophakic patients over 18 years old with open angle glaucoma or related conditions and a good quality endothelial image.
Not a fit: Patients with corneal diseases, previous ocular surgeries, or specific syndromes affecting the cornea may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques that minimize corneal endothelial cell loss in glaucoma patients.
How similar studies have performed: While there is limited data on this specific comparison, similar studies have explored the effects of tube placement in glaucoma surgeries, indicating potential for meaningful advancements.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years * Informed consent * Pseudophakic * Open angle glaucoma, pseudoexfoliation glaucoma, pigment dispersion glaucoma or angle closure glaucoma with sufficiently deep anterior chamber * Endothelial image at baseline of fair or good quality Exclusion Criteria: * Iridocorneal endothelial syndrome or posterior polymorphous dystrophy * Eyes with a history of penetrating trauma * Eyes with a history of (intra)ocular surgery other than uncomplicated cataract surgery * Eyes with corneal disease * Synechiae posterior * Pregnant and lactating women
Where this trial is running
Rotterdam
- Oogziekenhuis Rotterdam — Rotterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Rene Wubbels
- Email: r.wubbels@oogziekenhuis.nl
- Phone: +31104023430
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.