Comparing two types of glaucoma drainage devices and their effects on the cornea
Comparing the Baerveldt and Paul Glaucoma Drainage Devices and Their Effects on the Corneal Endothelium
This study is testing whether a new glaucoma drainage device with a thinner tube causes less damage to the eye's surface compared to a standard device in patients with glaucoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Oogziekenhuis Rotterdam Academic / other |
| Locations | 1 site (Rotterdam) |
| Trial ID | NCT05344651 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effects of the Baerveldt and Paul glaucoma drainage devices (GDD) on the corneal endothelium in patients with glaucoma. It is a randomized trial involving phakic patients who are scheduled for surgical GDD implantation. The primary objective is to determine whether the Paul GDD, which has a thinner tube, causes less damage to the corneal endothelium compared to the Baerveldt GDD over a 24-month period. The study will measure endothelial cell density and tube position as key endpoints.
Who should consider this trial
Good fit: Ideal candidates are Caucasian patients over 18 years old with primary open-angle, pseudoexfoliative, or pigmentary glaucoma.
Not a fit: Patients with a history of intraocular surgery or significant ocular comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a glaucoma treatment option that minimizes corneal damage.
How similar studies have performed: While there have been studies on glaucoma drainage devices, this specific comparison of the Baerveldt and Paul devices is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years. * Informed consent. * Caucasian ethnicity (to facilitate comparison of results with those of earlier work). Ethnicity will be based on self-reported origin of subject and/or parents. * Primary open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma. Exclusion Criteria: * History of intraocular surgery (e.g. vitrectomy, cataract surgery, cyclodestructive procedures etc). * History of ocular comorbidity (e.g. active uveitis, proliferative diabetic retinopathy). * Pseudophakia. * Functionally monocular patients. * Need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, keratoplasty, or retinal surgery) or an anticipated need for additional ocular surgery. * Narrow anterior chamber angle. * Best corrected visual acuity less than 0.1. * Severe blepharitis.
Where this trial is running
Rotterdam
- Oogziekenhuis Rotterdam — Rotterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Rene J 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.