Bleb Function and Morphology With Intratendon Injection of MMC Compared With Standard Method
conj mmc
1 other identifier
interventional
126
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 4, 2015
CompletedFirst Posted
Study publicly available on registry
March 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedMarch 11, 2015
December 1, 2014
1 year
March 4, 2015
March 10, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
IOP (intraocular pressure)
Goldmann applanation tonometry
until 6 months
Secondary Outcomes (1)
Bleb morphology
until 6 months
Study Arms (2)
using standard method of applying MMC
ACTIVE COMPARATORapplying MMC 0.02 % soaked sponges under conjunctival space for 1 to 3 minutes
intratendon injection of MMC
ACTIVE COMPARATORintratendon injection of 0.1 cc MMC 0.01% at the beginning of the procedure
Interventions
using 0.02 MMC soaked sponged under the conjunctiva for 1 to 3 minutes
Eligibility Criteria
You may qualify if:
- Advanced uncontrolled glaucoma patients.
You may not qualify if:
- History of any kind of intraocular surgery.
- Monocular patients.
- Unwillingness to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Tehran, Iran
Related Publications (1)
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.
PMID: 28100482DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Shahid Beheshti Medical University
Study Record Dates
First Submitted
March 4, 2015
First Posted
March 11, 2015
Study Start
December 1, 2014
Primary Completion
December 1, 2015
Last Updated
March 11, 2015
Record last verified: 2014-12