NCT00320957

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2006

Shorter than 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

January 1, 2006

Completed
4 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
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

May 26, 2008

Status Verified

May 1, 2008

First QC Date

May 1, 2006

Last Update Submit

May 23, 2008

Conditions

GlaucomasPterygium

Keywords

GlaucomaPterygiumcollagen matrixOculusGentrabeculectomyAnti scarringpterygium recurrencetissue engineeringAeon Astronologen

Outcome Measures

Primary Outcomes (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)

Zhongshan Hospital Fudan University

Shanghai, 200032, 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

  • Fei Yuan, MD

    Fudan 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

January 1, 2006

Study Completion

December 1, 2006

Last Updated

May 26, 2008

Record last verified: 2008-05

Locations

CN(1)