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Trabeculectomy With Ologen

This study has been terminated.
(The results were disappointing.)
Aeon Astron Europe B.V.
Information provided by (Responsible Party):
Henny Beckers, Maastricht University Medical Center Identifier:
First received: December 12, 2012
Last updated: May 22, 2015
Last verified: May 2015

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.

Condition Intervention
Glaucoma Device: Ologen

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trabeculectomy With Ologen-Pilot

Resource links provided by NLM:

Further study details as provided by Henny Beckers, Maastricht University Medical Center:

Primary Outcome Measures:
  • Postoperative intraocular pressure level [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Number of glaucoma medications [ Time Frame: 3 months ]

Other Outcome Measures:
  • 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  • number of patients withdrawn from study because of failure [ Time Frame: 3 months ]

Enrollment: 7
Study Start Date: August 2013
Study Completion Date: March 2015
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ologen implantation (single arm)
Ologen implantation as an adjunctive to trabeculectomy
Device: Ologen


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01753492

University Eye Clinic
Maastricht, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Aeon Astron Europe B.V.
  More Information

Responsible Party: Henny Beckers, MD, PhD, Ophthalmologist, Maastricht University Medical Center Identifier: NCT01753492     History of Changes
Other Study ID Numbers: NL42312.068.12/METC12-2-073
Study First Received: December 12, 2012
Last Updated: May 22, 2015

Keywords provided by Henny Beckers, Maastricht University Medical Center:
Intraocular pressure

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases processed this record on September 19, 2017