Bleb Function and Morphology With Intratendon Injection of MMC Compared With Standard Method

Glaucoma Clinical Trial

— conj mmc  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02385370
• Other study ID #: 92181
• Status: Recruiting
• Phase: Phase 3
• First received: March 4, 2015
• Last updated: March 10, 2015
• Start date: December 2014

Study information

• Verified date: December 2014
• Source: hahid Beheshti University of Medical Sciences
• Contact: mohammad pakravan
• Phone: 009822591616
• Email: labbafi[@]hotmail.com
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Advanced uncontrolled glaucoma patients.

Exclusion Criteria:

• History of any kind of intraocular surgery.

• Monocular patients.

• Unwillingness to participate in the study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP (intraocular pressure)	Goldmann applanation tonometry	until 6 months	Yes
Secondary	Bleb morphology	scoring the bleb morphologic features according to Indian Grading System	until 6 months	Yes