Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C

This study has been completed.
Sponsor:
Information provided by:
Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT00599950
First received: January 8, 2008
Last updated: January 23, 2008
Last verified: November 2007
  Purpose

To evaluate the confocal microscopy changes in keratocyte density at the anterior stromal after Photorefractive keratectomy (PRK) surgery, using intraoperative mitomycin C(Mitolem, LEMERY, S.A. de C.V. Mexico D.F. Reg. 136M92 SSA).


Condition Intervention Phase
Refractive Disorders
Drug: Mitomycin C and Photorefractive keratectomy (PRK)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C.

Resource links provided by NLM:


Further study details as provided by Asociación para Evitar la Ceguera en México:

Primary Outcome Measures:
  • A central scan of the anterior stroma was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy) [ Time Frame: Before surgery and 1 week, 1 month, 3 months, 6 months after surgery ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: January 2007
Study Completion Date: November 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)
Drug: Mitomycin C and Photorefractive keratectomy (PRK)
Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)
Placebo Comparator: 2
Photorefractive keratectomy (PRK)without mitomycin C.
Drug: Mitomycin C and Photorefractive keratectomy (PRK)
Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)

Detailed Description:

10 eyes of 10 patients underwent PRK,using intraoperative mitomycin C (Mitolem, LEMERY, S.A. de C.V. Mexico D.F. Reg. 136M92 SSA), and 10 eyes for the same patients underwent PRK without intraoperative mitomycin C. A central scan of the total corneal thickness was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy) after surgery, and 1 week, 1 month, 3 months, and 6 months after surgery. Corneal epithelial thickness and the Anterior stroma morphology were analyzed by using the NAVIS software V. 3.5.0 (NIDEK, Multi-Instrument Diagnostic System, Japan).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients ask for PRK surgery
  • Patients with stable refraction in the last year
  • Patients without systemic and ocular disease
  • Patients with 500 microns in pachymetry normal topography

Exclusion Criteria:

  • Patients cannot attend their appointments
  • Residual, recurrent or active ocular disease
  • Previous ocular surgery except PRK
  • Autoimmune or connective tissue disease
  • Pregnancy
  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: NCT00599950

Locations
Mexico
Asociación Para Evitar la Ceguera en Mëxico, Hospital "Luis Sánchez Bulnes".
Mexico city, Distrito Federal, Mexico, 04030
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
Principal Investigator: Ramirez F Manuel, MD APEC
  More Information

Publications:
Responsible Party: Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier: NCT00599950     History of Changes
Other Study ID Numbers: Cornea 4
Study First Received: January 8, 2008
Last Updated: January 23, 2008
Health Authority: Mexico: Ethics Committee

Keywords provided by Asociación para Evitar la Ceguera en México:
Mitomycin C
Corneal epithelium
Photorefractive keratectomy (PRK)
Confocal microscope

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases
Mitomycin
Mitomycins
Alkylating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014