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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01297803
First Posted: February 17, 2011
Last Update Posted: February 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shahid Beheshti University of Medical Sciences
  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 (Participant, 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 University of Medical Sciences:

Primary Outcome Measures:
  • corneal endothelial cell density [ Time Frame: six month ]
    specular microscopy

  • corneal endothelial cell polymorphism [ Time Frame: 6 months ]
    specular microscopy

  • corneal endothelial cell polymegathism [ Time Frame: 6 months ]
    specular microscopy


Secondary Outcome Measures:
  • IOP (intra ocular pressure) [ Time Frame: six months ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 University of Medical Sciences
  More Information

Responsible Party: Shahin Yazdani, Ophthalmic Research center
ClinicalTrials.gov Identifier: NCT01297803     History of Changes
Other Study ID Numbers: 8772
First Submitted: January 19, 2011
First Posted: February 17, 2011
Last Update Posted: February 17, 2011
Last Verified: November 2010

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