Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C.

Conditions
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Refractive Disorders

Intervention / Treatment
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* Drug: Mitomycin C and Photorefractive keratectomy (PRK)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK) | Drug: Mitomycin C and Photorefractive keratectomy (PRK)<br>* Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)<br>|
| Placebo Comparator: 2<br>Photorefractive keratectomy (PRK)without mitomycin C. | Drug: Mitomycin C and Photorefractive keratectomy (PRK)<br>* Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A central scan of the anterior stroma was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy) |  | Before surgery and 1 week, 1 month, 3 months, 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mitomycin C, Corneal epithelium, Photorefractive keratectomy (PRK), Confocal microscope