NCT00321035

Brief Summary

The purpose of this study is to determine whether the ologen (OculusGen) Collagen Matrix is effective and safe to implant as an aid of glaucoma and pterygium surgeries.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Last Updated

May 22, 2008

Status Verified

May 1, 2008

Enrollment Period

2.1 years

First QC Date

May 1, 2006

Last Update Submit

May 21, 2008

Conditions

GlaucomaPterygium

Keywords

GlaucomaPterygiumcollagen matrixoculusgenologentrabeculectomyanti scarringprevent recurrencetissue engineeringAeon Astron

Outcome Measures

Primary Outcomes (1)

  • 1. the effectiveness via the reduction of IOP and the incidence of pterygium recurrence

    180 day

Secondary Outcomes (1)

  • the safety via the incidence of complications and adverse events.

    180 day

Interventions

OculusGen Biodegradable Collagen Matrix ImplantDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Known allergic reactions to collagen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin Hospital of Beijing University

Beijing, 100044, China

Location

Related 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.

    PMID: 10937547RESULT

Related Links

MeSH Terms

Conditions

GlaucomaPterygium

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesConjunctival Diseases

Study Officials

  • Xiao-Xin Li, MD

    Renmin Hospital of Beijing University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 1, 2006

First Posted

May 3, 2006

Study Start

December 1, 2005

Primary Completion

January 1, 2008

Last Updated

May 22, 2008

Record last verified: 2008-05

Locations

CN(1)