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

NCT ID: NCT00320762

Last Updated: 2008-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Glaucoma Pterygium

Keywords

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Glaucoma Pterygium collagen matrix OculusGen trabeculectomy Anti scarring pterygium recurrence tissue engineering Aeon Astron

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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OculusGen Biodegradable Collagen Matrix Implant

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pro Top & Mediking Company Limited

INDUSTRY

Sponsor Role lead

Principal Investigators

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Hong Dai, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Hospital

Locations

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Beijing Hospital

Beijing, , China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 10937547 (View on PubMed)

Other Identifiers

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Mediking0501-2

Identifier Type: -

Identifier Source: org_study_id