Primary Baerveldt glaucoma implant versus trabeculectomy study.

Completed

• Conditions: glaucoma; 10018307

• Registration Number: NL-OMON40102
• Lead Sponsor: Oogziekenhuis Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

- Age 18 - 75 years.
- Informed consent.
- Caucasian.
- Expected to complete follow-up of 5 years.
- Primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma.
- Indication for IOP lowering surgery.

Exclusion Criteria

- IOP exacerbating glaucoma by further delay of pressure reduction.
- Normal pressure glaucoma.
- History of ocular surgery.
- History of ocular comorbidity.
- Pregnant or nursing women.
- Functionally monocular patients.
- Need for glaucoma surgery combined with other ocular procedures or aniticipated need for additional ocular surgery.
- Narrow anterior chamber angle.
- Best corrected visual acuity less than 0.1.
- Severe blepharitis.
- History of strabismus.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- IOP at 12 montns.<br /><br>- Failure rate at 12 months. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- IOP development during follow-up.<br /><br>- Failure rate during follow-up.<br /><br>- Need for supplemental medical therapy.<br /><br>- Best corrected visual acuity (ETDRS).<br /><br>- Visual field (HFA 24-2; SITA).<br /><br>- Motility changes.<br /><br>- Laser flare count.<br /><br>- Incidence and type of complications.</p><br>