Primary Baerveldt glaucoma implant versus trabeculectomy study.

Primary Baerveldt glaucoma implant versus trabeculectomy study. - Primary Baerveldt implant

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40102

Enrollment

120

Registered

2007-11-07

Start date

2008-07-11

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

glaucoma

Interventions

Baerveldt implant vs. trabeculectomy.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
- IOP at 12 montns. - Failure rate at 12 months.	—

Secondary

Measure	Time frame
- IOP development during follow-up. - Failure rate during follow-up. - Need for supplemental medical therapy. - Best corrected visual acuity (ETDRS). - Visual field (HFA 24-2; SITA). - Motility changes. - Laser flare count. - Incidence and type of complications.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)