Comparing the Baerveldt and Paul glaucoma drainage devices and their effects on the corneal endothelium

Comparing the Baerveldt and Paul glaucoma drainage devices and their effects on the corneal endothelium - Baerveldt vs Paul

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51284

Enrollment

160

Registered

2022-04-14

Start date

2022-07-01

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

glaucoma

Interventions

Either a Baerveldt or a Paul GDD implant.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age 18 - 75 years. Caucasian ethnicity (to facilitate comparison of results with those of earlier work). Primary open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma.

Exclusion criteria

Exclusion criteria: Normal pressure glaucoma. History of ocular surgery (e.g. intraocular or strabismus surgery, tenon*s capsule or conjunctiva 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.

Design outcomes

Primary

Measure	Time frame
Endothelial cell density and tube position at 24 months.	—

Secondary

Measure	Time frame
Intraocular pressure Motility Flare	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)