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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Shahid Beheshti Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT01297803
First received: January 19, 2011
Last updated: February 16, 2011
Last verified: November 2010
  Purpose

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 Intervention Phase
Glaucoma Patients Scheduled for Trabeculectomy
Drug: Mitomycin_c
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Corneal Endothelial Cell Loss Following Trabeculectomy With mitomycin_c Application Before Versus After Sclera Flap Dissection

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

Primary Outcome Measures:
  • corneal endothelial cell density [ Time Frame: six month ] [ Designated as safety issue: No ]
    specular microscopy

  • corneal endothelial cell polymorphism [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    specular microscopy

  • corneal endothelial cell polymegathism [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    specular microscopy


Secondary Outcome Measures:
  • IOP (intra ocular pressure) [ Time Frame: six months ] [ Designated as safety issue: No ]
    applanation tonometry


Study Start Date: November 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01297803

Locations
Iran, Islamic Republic of
Labbafinejad medical center Recruiting
Tehran, Iran, Islamic Republic of
Contact: shahin Yazdani    00982122585952    labbafi@hotmail.com   
Principal Investigator: shahin yazdani         
Sponsors and Collaborators
Shahid Beheshti Medical University
  More Information

No publications provided

Responsible Party: Shahin Yazdani, Ophthalmic Research center
ClinicalTrials.gov Identifier: NCT01297803     History of Changes
Other Study ID Numbers: 8772
Study First Received: January 19, 2011
Last Updated: February 16, 2011
Health Authority: Iran: Ethics commitee

Additional relevant MeSH terms:
Glaucoma
Corneal Endothelial Cell Loss
Ocular Hypertension
Eye Diseases
Corneal Diseases
Postoperative Complications
Pathologic Processes
Mitomycins
Mitomycin
Antimetabolites
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014