NCT01753492

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 20, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 25, 2015

Status Verified

May 1, 2015

Enrollment Period

1 year

First QC Date

December 12, 2012

Last Update Submit

May 22, 2015

Conditions

Glaucoma

Keywords

Intraocular pressureglaucomatrabeculectomyOlogen

Outcome Measures

Primary Outcomes (1)

  • Postoperative intraocular pressure level

    3 months

Secondary Outcomes (1)

  • Number of glaucoma medications

    3 months

Other Outcomes (4)

  • bleb aspect: hyperemia (grade 1, 2 or 3), bleb height (1, 2 or 3)

    3 months

  • surgery time

    3 months

  • complexity of surgical procedure

    3 months

  • +1 more other outcomes

Study Arms (1)

Ologen implantation (single arm)

EXPERIMENTAL

Ologen implantation as an adjunctive to trabeculectomy

Device: Ologen

Interventions

OlogenDEVICE
Ologen implantation (single arm)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary open-angle glaucoma with progression of visual field loss and/or uncontrolled intraocular pressure levels with medication.
  • Indication for trabeculectomy with mitomycin-C

You may not qualify if:

  • Unability to discontinue oral anticoagulants
  • Difficulty in reading or speaking Dutch
  • Previous ocular surgery (cataract surgery allowed)
  • Pregnant and breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Clinic

Maastricht, 6202 AZ, Netherlands

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Ophthalmologist

Study Record Dates

First Submitted

December 12, 2012

First Posted

December 20, 2012

Study Start

August 1, 2013

Primary Completion

August 1, 2014

Study Completion

March 1, 2015

Last Updated

May 25, 2015

Record last verified: 2015-05

Locations

NL(1)