Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C

Asociación para Evitar la Ceguera en México

Status and phase: Terminated; Phase 4

Conditions: Refractive Disorders

Treatments: Drug: Mitomycin C and Photorefractive keratectomy (PRK)

Study type: Interventional

Funder types: Other

Identifiers

NCT00599950

Cornea 4

Details and patient eligibility

About

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).

Full 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).

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)

Treatment:

Drug: Mitomycin C and Photorefractive keratectomy (PRK)

2

Placebo Comparator group

Description:

Photorefractive keratectomy (PRK)without mitomycin C.

Treatment:

Drug: Mitomycin C and Photorefractive keratectomy (PRK)