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

Glaucoma Patients Scheduled for Trabeculectomy Clinical Trial

Official title:

Corneal Endothelial Cell Loss Following Trabeculectomy With mitomycin_c Application Before Versus After Sclera Flap Dissection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01297803
• Other study ID #: 8772
• Status: Recruiting
• Phase: Phase 2
• First received: January 19, 2011
• Last updated: February 16, 2011
• Start date: November 2010
• Est. completion date: December 2011

Study information

• Verified date: November 2010
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics commitee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Corneal Endothelial Cell Loss
• Glaucoma Patients Scheduled for Trabeculectomy

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Labbafinejad medical center	Tehran

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	corneal endothelial cell density	specular microscopy	six month	No
Primary	corneal endothelial cell polymorphism	specular microscopy	6 months	No
Primary	corneal endothelial cell polymegathism	specular microscopy	6 months	No
Secondary	IOP (intra ocular pressure)	applanation tonometry	six months	No