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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00320762
First Posted: May 3, 2006
Last Update Posted: May 22, 2008
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.
Information provided by:
Pro Top & Mediking Company Limited
  Purpose
The purpose of this study is to determine whether the OculusGen Collagen Matrix is effective and safe to implant as an aid of glaucoma and pterygium surgeries.

Condition Intervention Phase
Glaucoma Pterygium Device: OculusGen Biodegradable Collagen Matrix Implant Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pro Top & Mediking Company Limited:

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

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

Estimated Enrollment: 60
Study Start Date: January 2006
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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 brings a certain pressure press on the top of the scleral flap which makes the dynamic balance for the aqueous system 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).
  Eligibility

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
Criteria

Inclusion Criteria:

  • Aged 18 years or over
  • Patient able to cooperate with study procedures and able to perform tests reliably
  • Patient willing to sign informed consent
  • Patient able and willing to complete postoperative follow-up requirements
  • Glaucoma: one/both eye(s) is/are affected by glaucoma
  • Pterygium: patient with pterygium

Exclusion Criteria:

  • Known allergic reactions to collagen
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00320762


Locations
China
Beijing Hospital
Beijing, China, 100730
Sponsors and Collaborators
Pro Top & Mediking Company Limited
Investigators
Principal Investigator: Hong Dai, MD Beijing Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00320762     History of Changes
Other Study ID Numbers: Mediking0501-2
First Submitted: May 1, 2006
First Posted: May 3, 2006
Last Update Posted: May 22, 2008
Last Verified: May 2008

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

Additional relevant MeSH terms:
Glaucoma
Pterygium
Ocular Hypertension
Eye Diseases
Conjunctival Diseases