Trabeculectomy With Ologen | NCT01753492

Studies
Trabeculectomy With Ologen

NCT01753492

Sponsor

Maastricht University Medical Center

Status

Terminated

Last Update Posted

May 25, 2015Estimated

Enrollment

7Actual

Phase

Not Applicable

Conditions

Glaucoma

Interventions

Ologen

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The results were disappointing.

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Aug 2014Actual

Completion Date

Mar 2015Actual

First Submitted Date

Dec 12, 2012

First Submission Date that Met QC Criteria

Dec 19, 2012

First Posted Date

Dec 20, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2015

Last Update Posted Date

May 25, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Henny Beckers, MD, PhD, Ophthalmologist, Maastricht University Medical CenterPrincipal Investigator

Lead Sponsor

Maastricht University Medical CenterOTHER

Collaborators

Name	Class
Aeon Astron Europe B.V.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ologen implantation (single arm)	Experimental	Ologen implantation as an adjunctive to trabeculectomy	Device: Ologen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ologen	Device		Ologen implantation (single arm)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative intraocular pressure level		3 months

Secondary Outcomes

Measure	Description	Time Frame
Number of glaucoma medications		3 months

Other Outcomes

Measure	Description	Time Frame
bleb aspect: hyperemia (grade 1, 2 or 3), bleb height (1, 2 or 3)		3 months
surgery time		3 months
complexity of surgical procedure

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Eye Clinic		Maastricht		6202 AZ	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided