Bleb Function and Morphology With Intratendon Injection of MMC Compared With Standard Method (conj mmc)
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|ClinicalTrials.gov Identifier: NCT02385370|
Recruitment Status : Unknown
Verified December 2014 by Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences.
Recruitment status was: Recruiting
First Posted : March 11, 2015
Last Update Posted : March 11, 2015
Patients with advanced glaucoma that are candidates for trabeculectomy will be included.
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.
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Drug: MMC||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bleb Function and Morphology With Intratendon Injection of 0.1 mg MMC in Comparison With Conventional Subtenon Application of 0.02% MMC Soaked Sponges in Trabeculectomy|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||December 2015|
Active Comparator: using standard method of applying MMC
applying MMC 0.02 % soaked sponges under conjunctival space for 1 to 3 minutes
using 0.02 MMC soaked sponged under the conjunctiva for 1 to 3 minutes
Active Comparator: intratendon injection of MMC
intratendon injection of 0.1 cc MMC 0.01% at the beginning of the procedure
0.1 cc of 0.01% MMC is injected into the tenon.
- IOP (intraocular pressure) [ Time Frame: until 6 months ]Goldmann applanation tonometry
- Bleb morphology [ Time Frame: until 6 months ]scoring the bleb morphologic features according to Indian Grading System
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385370
|Contact: mohammad email@example.com|
|Iran, Islamic Republic of|
|Tahran, Iran, Islamic Republic of|
|Contact: mohammad pakravan 009822591616 firstname.lastname@example.org|