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

Pterygium Clinical Trial

Official title:

Study of the Safety and Effectiveness of the Ologen (OculusGen) Collagen Matrix Implant as an Aid in Glaucoma and Pterygium Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00320957
• Other study ID #: Mediking0503
• Status: Completed
• Phase: Phase 3
• First received: May 1, 2006
• Last updated: May 23, 2008
• Start date: January 2006
• Est. completion date: December 2006

Study information

• Verified date: May 2008
• Source: Pro Top & Mediking Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucomas
• Pterygium

Intervention

Device:
• OculusGen Biodegradable Collagen Matrix Implant

Locations

Country	Name	City	State
China	Zhongshan Hospital Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Pro Top & Mediking Company Limited

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the effectiveness via the reduction of IOP and the incidence of pterygium recurrence		180 day
Secondary	the safety via the incidence of complications and adverse events.		180 day