Back to results

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

Primary Purpose

Glaucoma Patients Scheduled for Trabeculectomy

Status

Unknown status

Phase

Phase 2

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Mitomycin_c

About this trial

This is an interventional treatment trial for Glaucoma Patients Scheduled for Trabeculectomy

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Labbafinejad medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Mitomycin_c application before sclera flap dissection

Mitomycin_c application after sclera flapdissection

Arm Description

Outcomes

Primary Outcome Measures

corneal endothelial cell density

specular microscopy

corneal endothelial cell polymorphism

specular microscopy

corneal endothelial cell polymegathism

specular microscopy

Secondary Outcome Measures

IOP (intra ocular pressure)

applanation tonometry

Full Information

NCT ID

NCT01297803

First Posted

January 19, 2011

Last Updated

February 16, 2011

Sponsor

Shahid Beheshti University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01297803

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Unknown status

Study Start Date

November 2010 (undefined)

Primary Completion Date

June 2011 (Anticipated)

Study Completion Date

December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma Patients Scheduled for Trabeculectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

8. Arms, Groups, and Interventions

Arm Title

Mitomycin_c application before sclera flap dissection

Arm Type

Active Comparator

Arm Title

Mitomycin_c application after sclera flapdissection

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Mitomycin_c

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Mitomycin_c

Intervention Description

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

Primary Outcome Measure Information:

Title

corneal endothelial cell density

Description

specular microscopy

Time Frame

six month

Title

corneal endothelial cell polymorphism

Description

specular microscopy

Time Frame

6 months

Title

corneal endothelial cell polymegathism

Description

specular microscopy

Time Frame

6 months

Secondary Outcome Measure Information:

Title

IOP (intra ocular pressure)

Description

applanation tonometry

Time Frame

six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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).

Facility Information:

Facility Name

Labbafinejad medical center

City

Tehran

Country

Iran, Islamic Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

shahin Yazdani

Phone

00982122585952

labbafi@hotmail.com

First Name & Middle Initial & Last Name & Degree

shahin yazdani

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs