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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.
Register: CTRI
Last refreshed on: 25 March 2020
Main ID:  CTRI/2011/06/001836
Date of registration: 28-06-2011
Prospective Registration: Yes
Primary sponsor: None
Public title: 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.
Scientific title: A comparison of mitomycin C and subconjunctival bevacizumab in trabeculectomy for medically uncontrolled glaucoma.
Date of first enrolment: 01-02-2011
Target sample size: 60
Recruitment status: Open to Recruitment
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=2723
Study type:  Interventional
Study design:  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  
Phase:  Phase 2
Countries of recruitment
India
Contacts
Name: Parul Ichhpujani   
Address:  Deptt. of Ophthalmology, Third floor, D Block, Govt. Medical College and Hospital, Sector 32, 160030 Chandigarh, CHANDIGARH India
Telephone: 09501071591
Email: parul77@rediffmail.com
Affiliation:  Govt. Medical College and Hospital, Sector 32, Chandigarh
Name: Parul Ichhpujani   
Address:  Deptt. of Ophthalmology, Govt. Medical College and Hospital, Sector 32, Sector 32 160030 Chandigarh, CHANDIGARH India
Telephone: 09501071591
Email: parul77@rediffmail.com
Affiliation:  Govt. Medical College and Hospital, Sector 32, Chandigarh
Key inclusion & exclusion criteria
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:
Health Condition(s) or Problem(s) studied
Medically uncontrolled glaucoma
Intervention(s)
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
Primary Outcome(s)
Intraocular pressure and bleb morphologic featuresTimepoint: Postoperative day 1, week 1, month 1 and month 3
Secondary Outcome(s)
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
Secondary ID(s)
NIL
Source(s) of Monetary Support
None
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 25/04/2011
Contact:
Institute Ethics Committee
Results
Results available:
Date Posted:
Date Completed:
URL:
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