Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Trabeculectomy With Ologen

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Maastricht University Medical Center
Aeon Astron Europe B.V.
Information provided by (Responsible Party):
Henny Beckers, Maastricht University Medical Center Identifier:
First received: December 12, 2012
Last updated: August 29, 2013
Last verified: August 2013

December 12, 2012
August 29, 2013
August 2013
December 2013   (final data collection date for primary outcome measure)
Postoperative intraocular pressure level [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01753492 on Archive Site
Number of glaucoma medications [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
  • bleb aspect: hyperemia (grade 1, 2 or 3), bleb height (1, 2 or 3) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • surgery time [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • complexity of surgical procedure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • number of patients withdrawn from study because of failure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
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.

Not Provided
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Device: Ologen
Experimental: Ologen implantation (single arm)
Ologen implantation as an adjunctive to trabeculectomy
Intervention: Device: Ologen
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2013
December 2013   (final data collection date for primary outcome measure)

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
18 Years and older
Contact: Henny Beckers, MD, PhD +31 43 387 53 42
Contact: Carroll Webers, MD, PhD +31 43 387 53 46
Henny Beckers, Maastricht University Medical Center
Maastricht University Medical Center
Aeon Astron Europe B.V.
Not Provided
Maastricht University Medical Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP