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Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C

A

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

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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