Comparing the Baerveldt and Paul Glaucoma Drainage Devices and Their Effects on the Corneal Endothelium

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Objective: To determine whether the Paul tube induces less damage to the corneal endothelium than the Baerveldt GDD. Study design: Randomized clinical trial. Study population: Phakic patients scheduled for surgical GDD implantation. Intervention: Either a Baerveldt or a Paul GDD implant. Main study parameters/endpoints: Endothelial cell density and tube position at 24 months. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The Paul GDD may have a less harmful effect on corneal endothelium. Otherwise, both GDDs will probably have a similar risk/benefit profile. The risks of study-related assessments are negligible, burden is low, extra time is about 5 x 1.5 h (total 7.5 h) in two years.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Oogziekenhuis Rotterdam
RECRUITING
Rotterdam
Contact Information
Primary
Rene J Wubbels
r.wubbels@oogziekenhuis.nl
+31104023430
Backup
Susan Marinissen
S.Marinissen@oogziekenhuis.nl
+31104023449
Time Frame
Start Date: 2022-10-19
Estimated Completion Date: 2026-06
Participants
Target number of participants: 160
Treatments
Active_comparator: Baerveldt glaucoma drainage device
Experimental: Paul glaucoma drainage device
Related Therapeutic Areas
Sponsors
Leads: Oogziekenhuis Rotterdam

This content was sourced from clinicaltrials.gov