Ologen(Oculusgen)-Glaucoma and Pterygium Historical Control Study in China Shanghai Sixth People's Hospital
Study of the Safety and Effectiveness of the Ologen(OculusGen) Collagen Matrix Implant as an Aid in Glaucoma and Pterygium Surgery
2 other identifiers
interventional
60
1 country
1
Brief Summary
The purpose of this study is to determine whether the ologen (OculusGen) Collagen Matrix are effective and safe to implant as an aid of glaucoma surgery and pterygium excision surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2007
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 24, 2007
CompletedFirst Posted
Study publicly available on registry
May 25, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedOctober 7, 2011
June 1, 2008
4.7 years
May 24, 2007
October 6, 2011
Conditions
Keywords
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
Study Arms (1)
1
EXPERIMENTALologen™ collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy. After operation with ologen™ Collagen Matrix, anti-inflammatory eye-drops will be prescribed
Interventions
ologen™ treatment is used, the collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
Eligibility Criteria
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)
Shanghai sixth People's Hospital
Shanghai, 200233, China
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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qiang Wu, MD
Shanghai 6th People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2007
First Posted
May 25, 2007
Study Start
February 1, 2007
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
October 7, 2011
Record last verified: 2008-06