Primary Baerveldt glaucoma implant versus trabeculectomy study.

Completed

Conditions: Glaucoma.

Registration Number: NL-OMON27793

Lead Sponsor: Oogziekenhuis RotterdamSchiedamsevest 1803011 BH Rotterdam

Brief Summary: Islamaj E, Wubbels RJ, de Waard PWT. Primary Baerveldt versus trabeculectomey study after one year follow-up. Acta Ophthalmol. 2018; 96(6): e740-e746. PMID: 30022618 <br> Islamaj E, Jordaan-Kuip CP, Vermeer KA, Lemij HG, de Waard PWT. Motility Changes and Diplopia After Baerveldt Glaucoma Drainage Device Implantation or After Trabeculectomy. Trans Vis Sci Tech. 2018; 7(5): 7. PMID: 30221073 <br> Islamaj E, Wubbels RJ, de Waard PWT. Primary Baerveldt versus Trabeculectomy study after 5 years of follow-up. Acta Ophthalmol. 2020; 98(4): 400-407. PMID: 31729825 <br>

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

1. Age 18-75 years;

2. Informed consent;

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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Intraocular pressure at 12 months;<br /><br>2. Failure rate at 12 months.

Secondary Outcome Measures

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