OculusGen™ Collagen Matrix Implant for Phaco-Trabeculectomy in Primary Glaucoma: a Case-Control Study

December 4, 2009 updated by: Singapore National Eye Centre

Frequently glaucoma is not controlled with clinical treatment ("eyedrops") or laser surgery to control your eye pressure. If this raised pressure is sustained over a long period of time it can lead to permanent damage to the optic nerve (glaucoma) and in severe cases it can result in blindness. You also have cataracts, an opacification of the natural lens inside the eye that is impairing your vision. To prevent further vision loss due to glaucoma, your doctor has recommended glaucoma filtration surgery to lower your eye pressure, and cataract surgery at the same time to improve your sight.

The use of the anti-metabolite (Mitomycin-C) during the operation is currently the drug of choice to improve surgical outcome for glaucoma filtration surgery. Mitomycin-C is a potent antiscarring agent that reduces the amount of scar tissue produced after surgery which leads to better control of eye pressure. Although this potent drug is effective in increasing surgical success, its use is related to a higher risk of post surgical complications, some of which are sight threatening.

The Collagen Matrix Implant is a biodegradable implant (absorbed naturally by tissue), made from porcine collagen, which reduces scar tissue formed after glaucoma filtration surgery without the use of Mitomycin-C. This means that you could be less likely to have a failed glaucoma filtration surgery, and consequently, a poor eye pressure control. In addition, the risk of surgical failure may be reduced because with this technique, we will not be using potent drugs. However, the long-term effect of the OculusGenTm implant in glaucoma filtration surgery is not fully known.

The aim of the study is to determine whether the OculusGenTm implant can equal the success rate of Mitomycin-C in controlling eye pressure, without the potentially sight threatening complications associated with Mitomycin use. And at the same time, this study aim to determine if the implant can reduce potential complications related to glaucoma surgery when compared to the combined surgery augmented with anti-proliferative agents.

This study will recruit 66 subjects from patients attending the Singapore National Eye Centre over a period of 12-24 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

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

21 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with primary glaucoma.
  2. Age 21 years or over.
  3. Uncontrolled glaucoma, with failed medical and laser treatment, requiring trabeculectomy.
  4. Visually impairing cataract, requiring cataract extraction surgery.
  5. Subject able and willing to cooperate with investigation plan.
  6. Subject able and willing to complete postoperative follow-up requirements.
  7. Subject willing to sign informed consent form.

Exclusion Criteria:

  1. Known allergic reaction to porcine collagen.
  2. Vertical cup-disc ratio ≥ 0.9.
  3. Patients with secondary glaucoma.
  4. Previous intraocular surgery
  5. Subject is on warfarin and discontinuation is not recommended.
  6. Participation in an investigational study during the 30 days preceding trabeculectomy.
  7. Ocular infection within 14 days prior to trabeculectomy.

  8. Pregnant or breast-feeding women

    -

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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To assess the safety and effectiveness of the OculusGenTM Biodegradable Collagen Matrix Implant in Phaco-Trabeculectomy surgeries in patients with Primary Glaucoma

Collaborators and Investigators

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

Sponsor

Singapore National Eye Centre

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 Registration Dates

First Submitted

December 4, 2009

First Submitted That Met QC Criteria

December 4, 2009

First Posted (ESTIMATE)

December 7, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 7, 2009

Last Update Submitted That Met QC Criteria

December 4, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R539/27/2007

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.

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