Ologen (OculusGen)-Glaucoma MMC Control in Pakistan
October 6, 2011 updated by: Pro Top & Mediking Company Limited
Comparative Study of the Safety and Effectiveness Between Ologen (OculusGen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- Study Objective: To compare the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery. The primary endpoint is to prove the effectiveness via the reduction of IOP, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events.
- 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 OculusGen implant or trabeculectomy with mitomycin-C.
- 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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Punjab
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Rawalpindi, Punjab, Pakistan
- RMC & Allied Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Known allergic reaction to mitomycin-C or Bovine 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 1
20 patients will be recruited according to the enrollment acceptance criteria.Randomisation is performed using a sealed envelope system, where 40 shuffled envelopes designating the surgery to either trabeculectomy with mitomycin-C (MMC) and trabeculectomy with ologen™ Collagen matrix must be open before surgery.
Then, patients are allocated and trabeculectomy is performed.If ologen™ treatment is used, the collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
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If ologen™ treatment is used, the collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
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Active Comparator: 2
Following ethics committee approval, 20 patients with uncontrolled glaucoma will be randomised to trabeculectomy with mitomycin -C.
Randomisation is performed.
Then, trabeculectomy is performed
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If mitomycin -C is applied, a single cellulose sponge soaked with MMC (0.2mg/ml - 0.4mg/ml) is fashioned into an approximate 2.0 × 4.0 mm rectangular shape and applied to the scleral bed and subconjunctival space taking care to avoid exposure to the conjunctival wound edge.
Application time is 2 minutes for MMC.
Then, the area treated is copiously irrigated with balanced salt solution.
After operation, appropriate anti-inflammatory and antibiotic eye-drops will be prescribed.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
the effectiveness via the reduction of IOP
Time Frame: 180 day
|
180 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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the safety via the incidence of complications and adverse events.
Time Frame: 180 day
|
180 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Syed Imtiaz Ali, Professor, RMC & Allied Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Invest Ophthalmol Vis Sci. 2007 Feb;48(2):485.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
May 11, 2007
First Submitted That Met QC Criteria
May 11, 2007
First Posted (Estimate)
May 14, 2007
Study Record Updates
Last Update Posted (Estimate)
October 7, 2011
Last Update Submitted That Met QC Criteria
October 6, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mediking 0703
- OculusGen-2006-02-20
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.