Study Results
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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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2007-01-31
2011-10-31
Brief Summary
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Detailed Description
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2. Study Design: The study is designed as an open-label, randomized, parallel, comparative study. Patients who meet the inclusion/exclusion criteria and sign informed consent will be included. After enrollment, patients will be randomized into two groups: trabeculectomy with ologen (OculusGen) implant or trabeculectomy with mitomycin-C.
3. Follow-Up: There will be 7 post-operative and follow-up visits within 6 months of surgery: postoperative days 1, 7, 14, 30, 60, 90 and 180. A window of ± 7 days is allowed for the 30, 60, 90 day visits and ± 14 days for the 180 day visits. Further follow-up of subjects after the trial will be the responsibility of the investigator.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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OculusGen Biodegradable Collagen Matrix Implant
Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant
OculusGen Biodegradable Collagen Matrix Implant
Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant
MMC
Trabeculectomy with MMC
Trabeculectomy with MMC
Trabeculectomy with MMC
Interventions
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OculusGen Biodegradable Collagen Matrix Implant
Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant
Trabeculectomy with MMC
Trabeculectomy with MMC
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Pro Top & Mediking Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Rajul S Parikh, MD
Role: PRINCIPAL_INVESTIGATOR
V. S. T. Glaucoma Services, L. V. Prasad Eye Institute,
Locations
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L. V. Prasad Eye Institute
Hyderabad, Andhra Pradesh, India
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Park 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.
Other Identifiers
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OculusGen-2006-02-20
Identifier Type: -
Identifier Source: secondary_id
Mediking 0701
Identifier Type: -
Identifier Source: org_study_id