Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C - Full Text View

Purpose

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).

Condition	Intervention	Phase
Refractive Disorders	Drug: Mitomycin C and Photorefractive keratectomy (PRK)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C.

Resource links provided by NLM:

MedlinePlus related topics: Refractive Errors

Drug Information available for: Mitomycin

U.S. FDA Resources

Further study details as provided by Asociación para Evitar la Ceguera en México:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Enrollment:	10
Study Start Date:	January 2007
Study Completion Date:	November 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)	Drug: Mitomycin C and Photorefractive keratectomy (PRK) Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)
Placebo Comparator: 2 Photorefractive keratectomy (PRK)without mitomycin C.	Drug: Mitomycin C and Photorefractive keratectomy (PRK) Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599950

Locations

Mexico
Asociación Para Evitar la Ceguera en Mëxico, Hospital "Luis Sánchez Bulnes".
Mexico city, Distrito Federal, Mexico, 04030

Sponsors and Collaborators

Asociación para Evitar la Ceguera en México

Investigators

Principal Investigator:

Ramirez F Manuel, MD

APEC

More Information

Publications:

Midena E, Gambato C, Miotto S, Cortese M, Salvi R, Ghirlando A. Long-term effects on corneal keratocytes of mitomycin C during photorefractive keratectomy: a randomized contralateral eye confocal microscopy study. J Refract Surg. 2007 Nov;23(9 Suppl):S1011-4.

Ghirlando A, Gambato C, Midena E. LASEK and photorefractive keratectomy for myopia: clinical and confocal microscopy comparison. J Refract Surg. 2007 Sep;23(7):694-702.

Ying L, Xiao Z, Liuxueying Z, Yumei J. Clinical use of in vivo confocal microscopy through focusing in corneal refractive surgery. J Refract Surg. 2006 Nov;22(9 Suppl):S1041-6.

Responsible Party:	Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:	NCT00599950 History of Changes
Other Study ID Numbers:	Cornea 4
Study First Received:	January 8, 2008
Last Updated:	January 23, 2008
Health Authority:	Mexico: Ethics Committee

Keywords provided by Asociación para Evitar la Ceguera en México:

Mitomycin C
Corneal epithelium
Photorefractive keratectomy (PRK)
Confocal microscope

Additional relevant MeSH terms:

Refractive Errors
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents

Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents

ClinicalTrials.gov processed this record on May 21, 2013