Corneal Flap Thickness Planed vs Measured After LASIK by Using Tree Different Systems Cut

November 12, 2007 updated by: Asociación para Evitar la Ceguera en México
Determine the flap thickness created by femtosecond laser or a mechanical microkeratome using in vivo confocal microscopy and compare measured versus intended flap thickness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Eighty-six eyes had undergone LASIK were examined, al within 2 weeks to 1 month after surgery. Study involved 3 treatment groups: One with 30 eyes of 15 patients, corneal flaps were created with the microkeratome femtosecond laser 15 KHz 100μm (Intralase Corp, Irvine, Calif.), one with 30 eyes of 15 patients, corneal flaps were created with mechanical microkeratome (Hansatome 160μm (Chiron Vision Corp, Claremont, Calif) and one with 26 eyes of 13 patients, corneal flaps were created with mechanical microkeratome K3000 130μm ( BD Ophthalmic Systems, Waltham, Mass) . A central scan of the total corneal thickness was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy) before and at 2 weeks and 1 month 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)

43

Phase

  • Not Applicable

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
      • México 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients ask for LASIK 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 LASIK
  • 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: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: I
Corneal flaps were created with mechanical microkeratome (Hansatome 160μm (Chiron Vision Corp, Claremont, Calif)
Procedure: LASIK
Mechanical microkeratome Hansatome 160 microns
Procedure: LASIK
Mechanical microkeratome K 3000 130 microns
Procedure: LASIK
Femtoseconds laser 100 microns
Experimental: II
Corneal flaps were created with mechanical microkeratome K3000 130μm ( BD Ophthalmic Systems, Waltham, Mass) .
Procedure: LASIK
Mechanical microkeratome Hansatome 160 microns
Procedure: LASIK
Mechanical microkeratome K 3000 130 microns
Procedure: LASIK
Femtoseconds laser 100 microns
Experimental: III
Corneal flaps were created with microkeratome femtoseconds laser (Intralase Corp, Irvine, Calif.)
Procedure: LASIK
Mechanical microkeratome Hansatome 160 microns
Procedure: LASIK
Mechanical microkeratome K 3000 130 microns
Procedure: LASIK
Femtoseconds laser 100 microns

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measured thickness flap using Confocal microscopy study
Time Frame: 14 days after LASIK
14 days after LASIK

Collaborators and Investigators

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

Sponsor

Asociación para Evitar la Ceguera en México

Collaborators

Universidad Nacional Autonoma de Mexico

Investigators

  • Principal Investigator: Ramírez F. Manuel, MD, Asociación para Evitar la Ceguera
  • Study Chair: Ramírez G. Laura, MD, Asociación para Evitar la Ceguera

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

February 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

November 7, 2007

First Submitted That Met QC Criteria

November 12, 2007

First Posted (Estimate)

November 14, 2007

Study Record Updates

Last Update Posted (Estimate)

November 14, 2007

Last Update Submitted That Met QC Criteria

November 12, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cornea 1

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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