Primary Baerveldt glaucoma implant versus trabeculectomy study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27793

Enrollment

120

Registered

2007-11-27

Start date

2008-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years; 2. Informed consent; 3. Caucasian; 4. Expected to complete follow-up of 5 years; 5. Primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma; 6. Indication for IOP lowering surgery.

Exclusion criteria

Exclusion criteria: 1. IOP exacerbating glaucoma by further delay of pressure reduction. (Because implant remains closed until 6 weeks post-op, assigning such a patient to the Baerveldt group would be unethical).

Design outcomes

Secondary

Measure	Time frame
1. IOP development during follow-up; 2. Failure rate during follow-up; 3. Need for supplemental medical therapy; 4. Best corrected visual acuity (ETDRS); 5. Visual field (HFA 24-2; SITA); 6. Motility changes; 7. Laser flare count; 8. Incidence and type of complications.	—

Primary

Measure	Time frame
1. Intraocular pressure at 12 months; 2. Failure rate at 12 months.	—

Contacts

Public ContactP.W.T. Waard, de

Oogziekenhuis Rotterdam Schiedamsevest 180

deWaard@oogziekenhuis.nl+31(0)10 4017777

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)