Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C

Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C.

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00599950

Enrollment

Registered

2008-01-24

Start date

2007-01-31

Completion date

2007-11-30

Last updated

2024-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractive Disorders

Keywords

Mitomycin C, Corneal epithelium, Photorefractive keratectomy (PRK), Confocal microscope

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).

Interventions

DRUGMitomycin C and Photorefractive keratectomy (PRK)

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	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

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026