Trabeculectomy With Ologen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01753492
Recruitment Status : Terminated (The results were disappointing.)
First Posted : December 20, 2012
Last Update Posted : May 25, 2015
Aeon Astron Europe B.V.
Information provided by (Responsible Party):
Henny Beckers, Maastricht University Medical Center

December 12, 2012
December 20, 2012
May 25, 2015
August 2013
August 2014   (Final data collection date for primary outcome measure)
Postoperative intraocular pressure level [ Time Frame: 3 months ]
Same as current
Complete list of historical versions of study NCT01753492 on Archive Site
Number of glaucoma medications [ Time Frame: 3 months ]
Same as current
  • bleb aspect: hyperemia (grade 1, 2 or 3), bleb height (1, 2 or 3) [ Time Frame: 3 months ]
  • surgery time [ Time Frame: 3 months ]
  • complexity of surgical procedure [ Time Frame: 3 months ]
  • number of patients withdrawn from study because of failure [ Time Frame: 3 months ]
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 Applicable
Intervention Model: Single Group Assignment
Masking: None (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.
March 2015
August 2014   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Henny Beckers, Maastricht University Medical Center
Maastricht University Medical Center
Aeon Astron Europe B.V.
Not Provided
Maastricht University Medical Center
May 2015

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