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Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy: A Study in Germany

NCT01174420 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-05-09

No results posted yet for this study

Summary

The aim of this prospective randomized study is to investigate the efficacy and safety of trabeculectomy with ologen Collagen Matrix versus trabeculectomy using mitomycin C (MMC) in patients with medically uncontrolled open angle glaucoma.

Conditions

  • Open-angle Glaucoma

Interventions

DEVICE

Use of ologen Collagen Matrix in trabeculectomy

After trabeculectomy, place ologen Collagen Matrix on the top of the scleral flap under the conjunctiva before suturing

DRUG

Use of Mitomycin-C in trabeculectomy

After creating a scleral flap, a sponge with Mitomycin-C (0.02%) is applied on the scleral surface for 3 minutes. Afterwards, Mitomycin-C was rinsed out with balanced salt solution.

Sponsors & Collaborators

  • Aeon Astron Europe B.V.

    lead INDUSTRY

Principal Investigators

  • Thomas Dietlein, MD · Department of Ophthalmology, University of Cologne, Germany

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01174420 on ClinicalTrials.gov