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

Phase 2

• Conditions: Glaucoma Patients Scheduled for Trabeculectomy
• Interventions: Drug: Mitomycin_c

• Registration Number: NCT01297803
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-11
• Study Start: 2010-11
• Study First Submitted: 2011-01-19
• Study First Submitted QC: 2011-02-16
• Last Update Submitted: 2011-02-16
• Study First Posted: 2011-02-17
• Last Update Posted: 2011-02-17
• Primary Completion: 2011-06
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mitomycin_c application before sclera flap dissection	Mitomycin_c	-
Mitomycin_c application after sclera flapdissection	Mitomycin_c	-

Primary Outcome Measures

Name	Time	Method
corneal endothelial cell density	six month	specular microscopy
corneal endothelial cell polymorphism	6 months	specular microscopy
corneal endothelial cell polymegathism	6 months	specular microscopy

Secondary Outcome Measures

Name	Time	Method
IOP (intra ocular pressure)	six months	applanation tonometry

Trial Locations

Locations (1)

Labbafinejad medical center; 🇮🇷 Tehran, Iran, Islamic Republic of