Trabeculectomy With Ologen

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Maastricht University Medical Center
Sponsor:
Collaborator:
Aeon Astron Europe B.V.
Information provided by (Responsible Party):
Henny Beckers, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01753492
First received: December 12, 2012
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Trabeculectomy With Ologen-Pilot

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Postoperative intraocular pressure level [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of glaucoma medications [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: August 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01753492

Contacts
Contact: Henny Beckers, MD, PhD +31 43 387 53 42 henny.beckers@mumc.nl
Contact: Carroll Webers, MD, PhD +31 43 387 53 46 c.webers@mumc.nl

Locations
Netherlands
University Eye Clinic Recruiting
Maastricht, Netherlands, 6202 AZ
Contact: Henny Beckers, MD, PhD    +31 43 387 53 42    henny.beckers@mumc.nl   
Principal Investigator: Henny Beckers, MD, PhD         
Principal Investigator: Carroll Webers, MD, PhD         
Sponsors and Collaborators
Maastricht University Medical Center
Aeon Astron Europe B.V.
  More Information

No publications provided

Responsible Party: Henny Beckers, MD, PhD, Ophthalmologist, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01753492     History of Changes
Other Study ID Numbers: NL42312.068.12/METC12-2-073
Study First Received: December 12, 2012
Last Updated: August 29, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Maastricht University Medical Center:
Intraocular pressure
glaucoma
trabeculectomy
Ologen

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on July 26, 2014