Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C

January 23, 2008 updated by: Asociación para Evitar la Ceguera en México

Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Before surgery and 1 week, 1 month, 3 months, 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asociación para Evitar la Ceguera en México

Investigators

  • Principal Investigator: Ramirez F Manuel, MD, Asociación Para Evitar la Ceguera en México

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

January 8, 2008

First Submitted That Met QC Criteria

January 23, 2008

First Posted (Estimate)

January 24, 2008

Study Record Updates

Last Update Posted (Estimate)

January 24, 2008

Last Update Submitted That Met QC Criteria

January 23, 2008

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cornea 4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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