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

• Sponsor: Shahid Beheshti University of Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01297803
• Collaborator: (none)
• Location: 1
• Arms: 2
• Duration (Months): 13

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Patients Scheduled for Trabeculectomy	Drug: Mitomycin_c; Drug: Mitomycin_c	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Corneal Endothelial Cell Loss Following Trabeculectomy With mitomycin_c Application Before Versus After Sclera Flap Dissection
• Study Start Date: Nov 1, 2010
• Anticipated Primary Completion Date: Jun 1, 2011
• Anticipated Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mitomycin_c application before sclera flap dissection	Drug: Mitomycin_c; 0.02%.1,2,3,minutes match randomized in to two groups(before &after scleral flap dissection
Active Comparator: Mitomycin_c application after sclera flapdissection	Drug: Mitomycin_c; 0.02%.1,2,3,minutes match randomized in to two groups(before &after scleral flap dissection

Outcome Measures

Primary Outcome Measures

1. corneal endothelial cell density [six month]

   specular microscopy

2. corneal endothelial cell polymorphism [6 months]

   specular microscopy

3. corneal endothelial cell polymegathism [6 months]

   specular microscopy

Secondary Outcome Measures

1. IOP (intra ocular pressure) [six months]

   applanation tonometry

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Labbafinejad medical center	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

• Shahid Beheshti University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01297803
• Other Study ID Numbers: 8772
• First Posted: Feb 17, 2011
• Last Update Posted: Feb 17, 2011
• Last Verified: Nov 1, 2010

• Additional relevant MeSH terms: Glaucoma; Mitomycins; Mitomycin

Study Results

No Results Posted as of Feb 17, 2011