Trabeculectomy with Ologen®-Pilot

Completed

Conditions: glaucoma
primary open-angle glaucoma
10018307

Registration Number: NL-OMON40101

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

• Age 18 year or older.
• Primary open-angle glaucoma with progression of visual field loss and/or uncontrolled intraocular pressure levels with medication.
• Indication for trabeculectomy with mitomycin-C.

Exclusion Criteria

• Unability to discontinue oral anticoagulants.
• Previous ocular surgery (with the exemption of clear cornea cataract surgery).
• Ocular infection within 14 days prior to trabeculectomy.
• Pregnant and breastfeeding women.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter/endpoint<br /><br>• The number of patients with an intraocular pressure level of 15 and lower,<br /><br>and at least a 20% decrease from baseline at the last postoperative visit<br /><br>(three months after surgery).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters/endpoints<br /><br>• The number of glaucoma medications needed at the last postoperative visit.<br /><br>• Peroperative and postoperative complications after trabeculectomy with<br /><br>adjuvant Ologen® implantation.<br /><br>• Postoperative bleb aspect after trabeculectomy with adjuvant Ologen®<br /><br>implantation.<br /><br>• Surgery time of trabeculectomy with adjuvant Ologen® implantation.<br /><br>• Complexity of the surgical procedure (trabeculectomy with adjuvant Ologen®<br /><br>implantation); number of sutures, handling (resizing and reshaping) the Ologen®<br /><br>implant.<br /><br>• The number of patients withdrawn from the study as a result of failure of the<br /><br>surgical procedure and needing additional eye surgery.</p><br>