Ologen (OculusGen)-Glaucoma MMC Control Trial in India
Comparative Study of the Safety and Effectiveness Between Ologen (OculusGen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery
2 other identifiers
interventional
40
1 country
1
Brief Summary
The purpose of this study is to compare the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2007
Longer than P75 for phase_4
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
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 15, 2007
CompletedFirst Posted
Study publicly available on registry
March 19, 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
October 1, 2011
4.8 years
March 15, 2007
October 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the effectiveness via the reduction of IOP
180 day
Secondary Outcomes (1)
the safety via the incidence of complications and adverse events.
180 day
Study Arms (2)
OculusGen Biodegradable Collagen Matrix Implant
EXPERIMENTALTrabeculectomy with OculusGen Biodegradable Collagen Matrix Implant
MMC
ACTIVE COMPARATORTrabeculectomy with MMC
Interventions
Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant
Eligibility Criteria
You may qualify if:
- Age 18 years or over.
- Uncontrolled glaucoma, with failed medical and laser treatment, requiring trabeculectomy.
- Subject able and willing to cooperate with investigation plan.
- Subject able and willing to complete postoperative follow-up requirements.
- Subject willing to sign informed consent form.
You may not qualify if:
- Known allergic reaction to mitomycin-C or porcine collagen.
- Subject is on warfarin and discontinuation is not recommended.
- Normal tension glaucoma.
- Participation in an investigational study during the 30 days preceding trabeculectomy.
- Ocular infection within 14 days prior to trabeculectomy.
- Pregnant or breast-feeding women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
L. V. Prasad Eye Institute
Hyderabad, Andhra Pradesh, 500 034, India
Related Publications (3)
Chen HS, Ritch R, Krupin T, Hsu WC. Control of filtering bleb structure through tissue bioengineering: An animal model. Invest Ophthalmol Vis Sci. 2006 Dec;47(12):5310-4. doi: 10.1167/iovs.06-0378.
PMID: 17122118RESULTHsu 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: 10937547RESULTPark J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.
PMID: 36912740DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rajul S Parikh, MD
V. S. T. Glaucoma Services, L. V. Prasad Eye Institute,
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2007
First Posted
March 19, 2007
Study Start
January 1, 2007
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
October 7, 2011
Record last verified: 2011-10