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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

January 8, 2008
January 23, 2008
January 2007
January 2007   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00599950 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C
Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C.

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).

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).

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Refractive Disorders
Drug: Mitomycin C and Photorefractive keratectomy (PRK)
Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)
  • Experimental: 1
    Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)
    Intervention: Drug: Mitomycin C and Photorefractive keratectomy (PRK)
  • Placebo Comparator: 2
    Photorefractive keratectomy (PRK)without mitomycin C.
    Intervention: Drug: Mitomycin C and Photorefractive keratectomy (PRK)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
November 2007
January 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT00599950
Cornea 4
Yes
Asociación para Evitar la Ceguera en México
Asociación para Evitar la Ceguera en México
Not Provided
Principal Investigator: Ramirez F Manuel, MD APEC
Asociación para Evitar la Ceguera en México
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP