Trabeculectomy With Ologen

Not Applicable

Terminated

• Conditions: Glaucoma
• Interventions: Device: Ologen

• Registration Number: NCT01753492
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

Trabeculectomy is the gold standard procedure for the surgical treatment of glaucoma. Antimetabolites such as mitomycin-C (MMC)are widely used as an adjunctive during surgery to prevent scarring of the bleb. MMC has the risk for creating thin bleb walls, avascular blebs, and increased risk to infection, blebitis and endophthalmitis.

Recently, a biodegradable porous collagen-glycosaminoglycan copolymer matrix implant (Ologen), has become available for glaucoma surgery.Although a few studies on filtering surgery with Ologen implantation have been performed, there is yet no conclusive evidence on effectivity and safety with Ologen implantation when compared to trabeculectomy with MMC.

This is a prospective intervention pilot study to determine the degree of intraocular pressure (IOP) lowering of trabeculectomy with Ologen implantation in comparison to trabeculectomy with MMC. Additionally, the safety (per- and postoperative complications) of the two procedures will be compared.

The study hypothesis is that trabeculectomy with Ologen will be a safer procedure than trabeculectomy with MMC, but probably at the cost of a less potent IOP lowering.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-12
• Study First Submitted QC: 2012-12-19
• Study First Posted: 2012-12-20
• Study Start: 2013-08
• Primary Completion: 2014-08
• Study Completion: 2015-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-22
• Last Update Posted: 2015-05-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• 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
• Difficulty in reading or speaking Dutch
• Previous ocular surgery (cataract surgery allowed)
• Pregnant and breastfeeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ologen implantation (single arm)	Ologen	Ologen implantation as an adjunctive to trabeculectomy

Primary Outcome Measures

Name	Time	Method
Postoperative intraocular pressure level	3 months

Secondary Outcome Measures

Name	Time	Method
Number of glaucoma medications	3 months

Trial Locations

Locations (1)

University Eye Clinic; 🇳🇱 Maastricht, Netherlands