Status:
RECRUITING
Comparing the Baerveldt and Paul Glaucoma Drainage Devices and Their Effects on the Corneal Endothelium
Lead Sponsor:
Oogziekenhuis Rotterdam
Conditions:
Glaucoma
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Rationale: The Baerveldt glaucoma drainage device (GDD) successfully reduces intraocular pressure but also involves a risk of corneal endothelial deterioration. Supposedly, the tip of a GDD tube with ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT05344651
Start Date
October 19 2022
End Date
June 1 2026
Last Update
December 13 2022
Active Locations (1)
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1
Oogziekenhuis Rotterdam
Rotterdam, Netherlands, 3011BH