NCT00524758

Brief Summary

To compare the safety and effectiveness between ologen collagen matrix and mitomycin-C (MMC) in glaucoma surgery. The ologen collagen matrix implantation procedure is same as traditional trabeculectomy except implant the ologen collagen matrix on the top of sclera flap after one loose stich the sclera flap. The MMC application is as the standard.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2007

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 5, 2007

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

4.3 years

First QC Date

September 4, 2007

Last Update Submit

June 26, 2017

Conditions

Open Angle GlaucomaAngle Closure GlaucomaUveitis GlaucomaYoung Age GlaucomaNeovascular GlaucomaHigh Risk Patient

Keywords

ologenoculusgencollagen matrixtrabeculectomyfiltering surgerymitomycin-CMMCAeon Astron

Outcome Measures

Primary Outcomes (1)

  • IOP <21mmHg without anti glaucoma medication

    180 days

Secondary Outcomes (1)

  • IOP<21mmHg or IOP drops more than 30% with anti glaucoma medication

    180-day

Study Arms (2)

Ologen in Trabeculectomy

EXPERIMENTAL

Ologen in Trabeculectomy

Device: ologen (oculusgen) collagen matrix

MMC in Trabeculectomy

ACTIVE COMPARATOR

MMC in Trabeculectomy

Drug: MMC in Trabeculectomy

Interventions

ologen (oculusgen) collagen matrixDEVICE

Implant ologen collagen matrix on the top of sclera flap after loose stiched the sclera flap. The traditional trabeculectomy is performed.

Also known as: ologen collagen matrix, oculusgen collagen matrix
Ologen in Trabeculectomy
MMC in TrabeculectomyDRUG

MMC in Trabeculectomy

MMC in Trabeculectomy

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Max anti glaucoma medication failed,

You may not qualify if:

  • Age less than 18, woman in pregnant, hemodialysis patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tartu University Clinics

Tartu, Estonia

Location

Related Publications (1)

  • Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.

    PMID: 36912740DERIVED

Related Links

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma, Angle-ClosureGlaucoma, Neovascular

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Filtering SurgeryOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Kuldar Kaljurand, MD

    University of Tartu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2007

First Posted

September 5, 2007

Study Start

July 1, 2007

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

June 27, 2017

Record last verified: 2017-06

Locations

ES(1)