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

This study has been completed.
Sponsor:
Collaborator:
Universidad Nacional Autonoma de Mexico
Information provided by:
Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT00558324
First received: November 7, 2007
Last updated: November 12, 2007
Last verified: November 2007
  Purpose

Determine the flap thickness created by femtosecond laser or a mechanical microkeratome using in vivo confocal microscopy and compare measured versus intended flap thickness.


Condition Intervention
Refractive Errors
Procedure: LASIK

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Corneal Flap Thickness Planed vs Measured After LASIK by Using Tree Different Systems Cut

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Measured thickness flap using Confocal microscopy study [ Time Frame: 14 days after LASIK ]

Enrollment: 43
Study Start Date: February 2007
Study Completion Date: October 2007
Arms Assigned Interventions
Experimental: I
Corneal flaps were created with mechanical microkeratome (Hansatome 160μm (Chiron Vision Corp, Claremont, Calif)
Procedure: LASIK
Mechanical microkeratome Hansatome 160 microns
Experimental: II
Corneal flaps were created with mechanical microkeratome K3000 130μm ( BD Ophthalmic Systems, Waltham, Mass) .
Procedure: LASIK
Mechanical microkeratome K 3000 130 microns
Experimental: III
Corneal flaps were created with microkeratome femtoseconds laser (Intralase Corp, Irvine, Calif.)
Procedure: LASIK
Femtoseconds laser 100 microns

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00558324

Locations
Mexico
Asociación Para Evitar la Ceguera en Mëxico, Hospital "Luis Sánchez Bulnes".
México city, Distrito Federal, Mexico, 04030
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
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
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00558324     History of Changes
Other Study ID Numbers: Cornea 1
Study First Received: November 7, 2007
Last Updated: November 12, 2007
Health Authority: Mexico: Ethics Committee

Keywords provided by Asociación para Evitar la Ceguera en México:
LASIK
Confocal microscopy
Flap

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 15, 2014