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

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.

Condition or disease Intervention/treatment Phase
Glaucoma Device: Ologen Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trabeculectomy With Ologen-Pilot
Study Start Date : August 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Ologen implantation (single arm)
Ologen implantation as an adjunctive to trabeculectomy
Device: Ologen

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

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

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 number of patients withdrawn from study because of failure [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01753492

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

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
First Posted: December 20, 2012    Key Record Dates
Last Update Posted: May 25, 2015
Last Verified: May 2015

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

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases