Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00599950
• Date of registration: 08/01/2008
• Prospective Registration: No
• Primary sponsor: Asociación para Evitar la Ceguera en México
• Public title: Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C
• Scientific title: Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C.
• Date of first enrolment: January 2007
• Target sample size: 10
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00599950
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Mexico

Contacts

• Name: Ramirez F Manuel, MD
• Affiliation: APEC

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Refractive Disorders

Intervention(s)

Drug: Mitomycin C and Photorefractive keratectomy (PRK)

Primary Outcome(s)

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]

Secondary ID(s)

Cornea 4

Source(s) of Monetary Support

Please refer to primary and secondary sponsors