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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2011/06/001836 |
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Date of registration:
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28-06-2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A study to see how two different agents, Mitomycin C (commonly used) and bevacizumab (newer agent)influence the outcome of surgery for medically uncontrolled glaucoma.
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Scientific title:
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A comparison of mitomycin C and subconjunctival bevacizumab in
trabeculectomy for medically uncontrolled glaucoma.
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Date of first enrolment:
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01-02-2011 |
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Target sample size:
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60 |
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Recruitment status: |
Open to Recruitment |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=2723 |
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Study type:
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Interventional |
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Study design:
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Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
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Phase:
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Phase 2
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Countries of recruitment
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India
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Contacts
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Name:
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Parul Ichhpujani
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Address:
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Deptt. of Ophthalmology, Govt. Medical College and Hospital, Sector 32, Sector 32
160030
Chandigarh, CHANDIGARH
India |
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Telephone:
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09501071591 |
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Email:
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parul77@rediffmail.com |
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Affiliation:
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Govt. Medical College and Hospital, Sector 32, Chandigarh |
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Name:
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Parul Ichhpujani
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Address:
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Deptt. of Ophthalmology,
Third floor, D Block,
Govt. Medical College and Hospital, Sector 32,
160030
Chandigarh, CHANDIGARH
India |
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Telephone:
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09501071591 |
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Email:
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parul77@rediffmail.com |
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Affiliation:
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Govt. Medical College and Hospital, Sector 32, Chandigarh |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- 18-70 years of age
- Patients with primary or secondary, open or closed angle glaucoma.
- Patients with intraocular pressure greater than 21 mmHg despite use of anti-glaucoma medications.
Exclusion criteria: - Patients <18 years of age
- Pregnant and lactating females.
- Patients undergoing concurrent cataract surgery.
- Patients with failed trabeculectomy.
- Patients with active uveitis.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- Medically uncontrolled glaucoma
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Intervention(s)
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Intervention1: Bevacizumab: 0.05 ml of reconstituted bevacizumab drug (1.25 mg) will be injected subconjunctivally adjacent to the bleb.
Control Intervention1: Mitomycin C: 0.2 mg/ml for 1-2 minutes
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Primary Outcome(s)
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Intraocular pressure and bleb morphologic featuresTimepoint: Postoperative day 1, week 1, month 1 and month 3
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Secondary Outcome(s)
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Complications including systemic complications, number of antiglaucoma medications required post surgery and number of bleb needlings if any.Timepoint: Postoperative day 1, week 1, month 1 and month 3
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Source(s) of Monetary Support
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None
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Ethics review
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Status: Approved
Approval date: 25/04/2011
Contact:
Institute Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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