Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery

April 1, 2012 updated by: Pro Top & Mediking Company Limited
To compare the safety and effectiveness of oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) in glaucoma surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To compare the safety and effectiveness in between oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) for glaucoma surgery. The surgery is performed by the gold standard of trabeculectomy. Mitomycin-C(MMC) is applied for those who not collagen matrix implanted.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Koln, Germany, 50931
        • Hospital of Universität Köln

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Open angle glaucoma
  • Maxima anti-glaucoma medication failed
  • Age>18
  • Able to complete the follow up

Exclusion Criteria:

  • Topical eye inflammation
  • Angle closure glaucoma
  • Deformity glaucoma
  • One eye glaucoma
  • Previous conjunctiva opened
  • Allergy to collagen

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MITOMYCIN-C
Following ethics committee approval, 20 patients with uncontrolled glaucoma will be will be recruited according to the enrollment acceptance criteria. Randomisation is performed and patients are allocated for trabeculectomy with Mitomycin-C.
Drug: Mitomycin-C(MMC) and glaucoma filtering surgery
If mitomycin -C is applied, a single cellulose sponge soaked with Mitomycin-C(MMC) (0.2mg/ml - 0.4mg/ml) is fashioned into an approximate 2.0 × 4.0 mm rectangular shape and applied to the scleral bed and subconjunctival space taking care to avoid exposure to the conjunctival wound edge. Application time is 2 minutes for MMC. Then, the area treated is copiously irrigated with balanced salt solution. After operation, appropriate anti-inflammatory and antibiotic eye-drops will be prescribed.
Other Names:
  • Mitomycin C
Experimental: ologen (Oculusgen)
20 patients will be recruited according to the enrollment acceptance criteria. Randomisation is performed and patients are allocated for trabeculectomy with ologen implant. The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
Device: Collagen Matrix in Glaucoma Filtering Surgery
Collagen Matrix implantation in Glaucoma Filtering Surgery
Other Names:
  • ologen™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Intraocular Pressure Change
Time Frame: 360 days
Postoperative intraocular pressure change at 360 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.
360 days
Postoperative Intraocular Pressure Change
Time Frame: 180 days
Postoperative intraocular pressure change at 180 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.
180 days
Postoperative Intraocular Pressure Change
Time Frame: 90 days
Postoperative intraocular pressure change at 90 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.
90 days
Postoperative Intraocular Pressure Change
Time Frame: 30 days
Postoperative intraocular pressure change at 30 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 360 days
Incidence (percentage) for complications recorded: Hyphema, early hypotony(<7days), late hypotony(>7days), shallow anterior chamber, choroidal detachment, early leak(<7days), late leak(>7days), Tenon's cysts, and revision surgery for up to 360 days.
360 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pro Top & Mediking Company Limited

Investigators

  • Principal Investigator: Thomas Dietlein, Ph. D, MD, Universität Köln

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

September 29, 2007

First Submitted That Met QC Criteria

October 1, 2007

First Posted (Estimate)

October 2, 2007

Study Record Updates

Last Update Posted (Estimate)

April 25, 2012

Last Update Submitted That Met QC Criteria

April 1, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ologen-Koln

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Open Angle Glaucoma

Clinical Trials on Mitomycin-C(MMC) and glaucoma filtering surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe