Comparison of Two Method Antimetabolites Application on Corneal Function in Trabeculectomy Surgery

NCT ID: NCT01297803

Last Updated: 2011-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-12-31

Brief Summary

Application of antimetabolite agents such as mitomycin_c has improved trabeculectomy results and better control of intraocular pressure complications such as corneal endothelial cell loss. However, Mitomycin_c can be applied remain a concern before or after sclera flap dissection. Mitomycin_c application after sclera flap dissection probably increases corneal endothelial cell loss. This study compares Mitomycin_c application two methods: before and after sclera flap dissection with regard to success rate and complication. patients on base of Mitomycin_c application time (1-2-3) minutes will be match randomise in to two groups( before and after sclera flap dissection) corneal. Endothelial cell density, polymorphism, polymegathism and intraocular pressure before and one month, three months, six months after surgery will measured.

Conditions

Glaucoma Patients Scheduled for Trabeculectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Mitomycin_c application before sclera flap dissection

Group Type: ACTIVE_COMPARATOR

Mitomycin_c

Intervention Type: DRUG

0.02%.1,2,3,minutes match randomized in to two groups(before \&after scleral flap dissection

Mitomycin_c application after sclera flapdissection

Group Type: ACTIVE_COMPARATOR

Mitomycin_c

Intervention Type: DRUG

0.02%.1,2,3,minutes match randomized in to two groups(before \&after scleral flap dissection

Interventions

Mitomycin_c

0.02%.1,2,3,minutes match randomized in to two groups(before \&after scleral flap dissection

Intervention Type: DRUG

Mitomycin_c

0.02%.1,2,3,minutes match randomized in to two groups(before \&after scleral flap dissection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age Range between 18 to 80 years old
• Trabeculectomy to JOAC, POAG, CACG, PXF, pigment dispersion syndrome.

Exclusion Criteria

• Secondary glaucoma (active uveitis, NVG, specific syndromes such as axenfeld rieger, Iridocorneal Endothelial syndrome, aniridia, peters, etc).

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Ophthalmic Research center

Locations

Labbafinejad medical center

Tehran, , Iran

Site Status: RECRUITING

Countries

Iran

Facility Contacts

shahin Yazdani

Role: primary

labbafi@hotmail.com

00982122585952

Other Identifiers

8772

Identifier Type: -

Identifier Source: org_study_id