Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C

NCT ID: NCT00599950

Last Updated: 2024-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-11-30

Brief Summary

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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

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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).

Conditions

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Refractive Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

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

Group Type EXPERIMENTAL

Mitomycin C and Photorefractive keratectomy (PRK)

Intervention Type DRUG

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

2

Photorefractive keratectomy (PRK)without mitomycin C.

Group Type PLACEBO_COMPARATOR

Mitomycin C and Photorefractive keratectomy (PRK)

Intervention Type DRUG

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

Interventions

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Mitomycin C and Photorefractive keratectomy (PRK)

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asociación para Evitar la Ceguera en México

OTHER

Sponsor Role lead

Responsible Party

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Asociación para Evitar la Ceguera en México

Principal Investigators

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Ramirez F Manuel, MD

Role: PRINCIPAL_INVESTIGATOR

Asociación para Evitar la Ceguera en México

Locations

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Asociación Para Evitar la Ceguera en Mëxico, Hospital "Luis Sánchez Bulnes".

Mexico City, Mexico City, Mexico

Site Status

Countries

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Mexico

References

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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. doi: 10.3928/1081-597X-20071102-06.

Reference Type BACKGROUND
PMID: 18046999 (View on PubMed)

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. doi: 10.3928/1081-597X-20070901-08.

Reference Type BACKGROUND
PMID: 17912939 (View on PubMed)

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. doi: 10.3928/1081-597X-20061102-07.

Reference Type BACKGROUND
PMID: 17444091 (View on PubMed)

Other Identifiers

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Cornea 4

Identifier Type: -

Identifier Source: org_study_id

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