Trabeculectomy With Ologen

Trabeculectomy With Ologen-Pilot

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.

Study Overview

• Status: Terminated
• Conditions: Glaucoma
• Intervention / Treatment: Device: Ologen

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6202 AZ
    • University Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ologen implantation (single arm); Ologen implantation as an adjunctive to trabeculectomy	Device: Ologen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative intraocular pressure level	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of glaucoma medications	3 months

Other Outcome Measures

Outcome Measure	Time Frame
bleb aspect: hyperemia (grade 1, 2 or 3), bleb height (1, 2 or 3)	3 months
surgery time	3 months
complexity of surgical procedure	3 months
number of patients withdrawn from study because of failure	3 months

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Aeon Astron Europe B.V.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: December 12, 2012
• First Submitted That Met QC Criteria: December 19, 2012
• First Posted (Estimate): December 20, 2012

Study Record Updates

• Last Update Posted (Estimate): May 25, 2015
• Last Update Submitted That Met QC Criteria: May 22, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Intraocular pressure; glaucoma; trabeculectomy; Ologen
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: NL42312.068.12/METC12-2-073