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Trial record 1 of 1 for:    NCT02385370
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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
Sponsor:
Information provided by (Responsible Party):
Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences

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.


Condition or disease Intervention/treatment Phase
Glaucoma Drug: MMC Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Active Comparator: using standard method of applying MMC
applying MMC 0.02 % soaked sponges under conjunctival space for 1 to 3 minutes
Drug: MMC
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
Drug: MMC
0.1 cc of 0.01% MMC is injected into the tenon.




Primary Outcome Measures :
  1. IOP (intraocular pressure) [ Time Frame: until 6 months ]
    Goldmann applanation tonometry


Secondary Outcome Measures :
  1. Bleb morphology [ Time Frame: until 6 months ]
    scoring the bleb morphologic features according to Indian Grading System



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced uncontrolled glaucoma patients.

Exclusion Criteria:

  • History of any kind of intraocular surgery.
  • Monocular patients.
  • Unwillingness to participate in the study

Information from the National Library of Medicine

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


Contacts
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Contact: mohammad pakravan 009822591616 labbafi@hotmail.com

Locations
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Iran, Islamic Republic of
Recruiting
Tahran, Iran, Islamic Republic of
Contact: mohammad pakravan    009822591616    labbafi@hotmail.com   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zahra Rabbani Khah, Shahid Beheshti Medical University, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02385370    
Other Study ID Numbers: 92181
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: December 2014
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases