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

This study has been completed.
Sponsor:
Information provided by:
Pro Top & Mediking Company Limited
ClinicalTrials.gov Identifier:
NCT00320957
First received: May 1, 2006
Last updated: May 23, 2008
Last verified: May 2008
  Purpose

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 Intervention Phase
Glaucomas
Pterygium
Device: OculusGen Biodegradable Collagen Matrix Implant
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ]

Enrollment: 61
Study Start Date: January 2006
Estimated Study Completion Date: December 2006
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320957

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

Publications:
ClinicalTrials.gov Identifier: NCT00320957     History of Changes
Other Study ID Numbers: Mediking0503
Study First Received: May 1, 2006
Last Updated: May 23, 2008
Health Authority: China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 21, 2014