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Trabeculectomy With Ologen

Primary Purpose

Glaucoma

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Ologen
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Intraocular pressure, glaucoma, trabeculectomy, Ologen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Eye Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ologen implantation (single arm)

Arm Description

Ologen implantation as an adjunctive to trabeculectomy

Outcomes

Primary Outcome Measures

Postoperative intraocular pressure level

Secondary Outcome Measures

Number of glaucoma medications

Full Information

First Posted
December 12, 2012
Last Updated
May 22, 2015
Sponsor
Maastricht University Medical Center
Collaborators
Aeon Astron Europe B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT01753492
Brief Title
Trabeculectomy With Ologen
Official Title
Trabeculectomy With Ologen-Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
The results were disappointing.
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Aeon Astron Europe B.V.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Intraocular pressure, glaucoma, trabeculectomy, Ologen

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ologen implantation (single arm)
Arm Type
Experimental
Arm Description
Ologen implantation as an adjunctive to trabeculectomy
Intervention Type
Device
Intervention Name(s)
Ologen
Primary Outcome Measure Information:
Title
Postoperative intraocular pressure level
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of glaucoma medications
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
bleb aspect: hyperemia (grade 1, 2 or 3), bleb height (1, 2 or 3)
Time Frame
3 months
Title
surgery time
Time Frame
3 months
Title
complexity of surgical procedure
Time Frame
3 months
Title
number of patients withdrawn from study because of failure
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Eye Clinic
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands

12. IPD Sharing Statement

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Trabeculectomy With Ologen

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