Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C

Phase 4

Terminated

• Conditions: Refractive Disorders
• Interventions: Drug: Mitomycin C and Photorefractive keratectomy (PRK)

• Registration Number: NCT00599950
• Lead Sponsor: Asociación para Evitar la Ceguera en México

Brief Summary

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

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).

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2007-01
• Study Completion: 2007-11
• Study First Submitted: 2008-01-08
• Study First Submitted QC: 2008-01-23
• Study First Posted: 2008-01-24
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Mitomycin C and Photorefractive keratectomy (PRK)	Photorefractive keratectomy (PRK)without mitomycin C.
1	Mitomycin C and Photorefractive keratectomy (PRK)	Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Asociación Para Evitar la Ceguera en Mëxico, Hospital "Luis Sánchez Bulnes".; 🇲🇽 Mexico city, Distrito Federal, Mexico