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

Sponsored by:	Pro Top & Mediking Company Limited
Information provided by:	Pro Top & Mediking Company Limited
ClinicalTrials.gov Identifier:	NCT00320957

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 III

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Study of the Safety and Effectiveness of the Ologen (OculusGen) Collagen Matrix Implant as an Aid in Glaucoma and Pterygium Surgery

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:

Age 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 eyes are affected by glaucoma
Pterygium： patient with pterygium

Exclusion Criteria:

Known allergic reactions to collagen

Contacts and Locations

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

Zhongshan Hospital Fudan University

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications of Results:

Hsu WC, Spilker MH, Yannas IV, Rubin PA. Inhibition of conjunctival scarring and contraction by a porous collagen-glycosaminoglycan implant. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2404-11.

Study ID Numbers:	Mediking0503
Study First Received:	May 1, 2006
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00320957
Health Authority:	China: State 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

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Pterygium of the conjunctiva
Pterygium
Conjunctival Diseases

Recurrence
Hypertension
Ocular Hypertension
Cicatrix

ClinicalTrials.gov processed this record on January 16, 2009