Ologen (OculusGen)-Glaucoma and Pterygium Historical Control Study in China Zhong-Shan Hospital

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00320957
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : May 26, 2008
Information provided by:
Pro Top & Mediking Company Limited

Brief Summary:
The purpose of this study is to determine whether the OculusGen Collagen Matrix are effective and safe to implant as an aid of glaucoma surgery.

Condition or disease Intervention/treatment Phase
Glaucomas Pterygium Device: OculusGen Biodegradable Collagen Matrix Implant Phase 3

Detailed Description:
ologen (OculusGen) Collagen Matrix is a porous, scaffold matrix. It is to be implanted on the top of the scleral flap and beneath the conjunctiva and Tenon's capsule at the end of trabeculectomy. The pores in the scaffold matrix range from 20 to 200µm, a size that is suitable for fibroblasts to grow randomly, through the body of the matrix without causing scarring. The space occupied by the collagen matrix scaffold creates room for the development of a filtration bleb. Immediately after implantation, the collagen matrix is absorbed with the aqueous humor that bring a certain pressure press on the top of scleral flap which makes the dynamic balance for the aqueous system to keep the IOP in the right side. The collagen matrix is bio-degraded within 90 days and will leave a physiologic space for the filtration bleb to facilitate control of intraocular pressure (IOP).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Safety and Effectiveness of the Ologen (OculusGen) Collagen Matrix Implant as an Aid in Glaucoma and Pterygium Surgery
Study Start Date : January 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Collagen
U.S. FDA Resources

Primary Outcome Measures :
  1. the effectiveness via the reduction of IOP and the incidence of pterygium recurrence [ Time Frame: 180 day ]

Secondary Outcome Measures :
  1. the safety via the incidence of complications and adverse events. [ Time Frame: 180 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age 18 years or over
  2. Patient able to cooperate with study procedures and able to perform tests reliably
  3. Patient willing to sign informed consent
  4. Patient able and willing to complete postoperative follow-up requirements
  5. Glaucoma:one/both eyes are affected by glaucoma
  6. Pterygium: patient with pterygium

Exclusion Criteria:

  • Known allergic reactions to collagen

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00320957

Zhongshan Hospital Fudan University
Shanghai, China, 200032
Sponsors and Collaborators
Pro Top & Mediking Company Limited
Principal Investigator: Fei Yuan, MD Fudan University

Publications of Results: Identifier: NCT00320957     History of Changes
Other Study ID Numbers: Mediking0503
First Posted: May 3, 2006    Key Record Dates
Last Update Posted: May 26, 2008
Last Verified: May 2008

Keywords provided by Pro Top & Mediking Company Limited:
collagen matrix
Anti scarring
pterygium recurrence
tissue engineering
Aeon Astron

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Conjunctival Diseases