Bleb Function and Morphology With Intratendon Injection of MMC Compared With Standard Method
NCT ID: NCT02385370
Last Updated: 2015-03-11
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
PHASE3
126 participants
INTERVENTIONAL
2014-12-31
Brief Summary
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Thorough ophthalmic examination including best corrected visual acuity, slit lamp examination, intraocular pressure (IOP) measurement, gonioscopy, funduscopy and specularly microscopy will be performed for all participants. Patients will be assigned randomly to 2 groups. In one group they will undergo fornix based trabeculectomy with conventional MMC 0.02% soaked sponges application. In the other group 0.1 cc of 0.01 MMC will be injected into the tenon at the beginning of the surgery. The rest of the operation is the same for both groups as standard trabeculectomy. Ophthalmic examination including IOP measurement will be performed at one, 3 and 6th month post surgery. Specular microscopy will be requested at final follow up visit. Bleb morphology will be scored according to Indian grading system at 3rd and 6th months post surgery.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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using standard method of applying MMC
applying MMC 0.02 % soaked sponges under conjunctival space for 1 to 3 minutes
MMC
using 0.02 MMC soaked sponged under the conjunctiva for 1 to 3 minutes
intratendon injection of MMC
intratendon injection of 0.1 cc MMC 0.01% at the beginning of the procedure
MMC
0.1 cc of 0.01% MMC is injected into the tenon.
Interventions
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MMC
using 0.02 MMC soaked sponged under the conjunctiva for 1 to 3 minutes
MMC
0.1 cc of 0.01% MMC is injected into the tenon.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Monocular patients.
* Unwillingness to participate in the study
20 Years
ALL
No
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Responsible Party
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Zahra Rabbani Khah
Shahid Beheshti Medical University
Locations
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Tehran, , Iran
Countries
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Central Contacts
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Facility Contacts
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References
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Pakravan M, Esfandiari H, Yazdani S, Douzandeh A, Amouhashemi N, Yaseri M, Pakravan P. Mitomycin C-augmented trabeculectomy: subtenon injection versus soaked sponges: a randomised clinical trial. Br J Ophthalmol. 2017 Sep;101(9):1275-1280. doi: 10.1136/bjophthalmol-2016-309671. Epub 2017 Jan 18.
Other Identifiers
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92181
Identifier Type: -
Identifier Source: org_study_id
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