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Epi-LASIK : A Confocal Microscopy Analysis of the Corneal Epithelium and Anterior Stroma.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00599690
First Posted: January 24, 2008
Last Update Posted: January 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Asociación para Evitar la Ceguera en México
  Purpose
To evaluate the confocal microscopy findings at the corneal epithelium and anterior stroma after epi-LASIK Surgery.

Condition Intervention
Corneal Epithelium Procedure: Epi-LASK

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Epi-LASIK : A Confocal Microscopy Analysis of the Corneal Epithelium and Anterior Stroma.

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

Primary Outcome Measures:
  • A central scan of the total corneal thickness was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy) [ Time Frame: Before and at 2 weeks and 1 month after surgery ]

Secondary Outcome Measures:
  • There are no secondary outcome measures specified for this study [ Time Frame: There are no secondary outcome measures specified for this study ]

Enrollment: 10
Study Start Date: January 2006
Study Completion Date: September 2007
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Epithelial flaps were created with the Amadeus II, epi-LASIK-LASIK microkeratome (Ziemer ophthalmics systems AG, Switzerland). A Visx star 4 system (Visx, Santa Ana, CA, USA) was used to perform the laser ablation in all eyes
Procedure: Epi-LASK
10 eyes of 10 patients underwent epi-LASK, epithelial flaps were created with the Amadeus II, epi-LASIK-LASIK microkeratome (Ziemer ophthalmics systems AG, Switzerland). A Visx star 4 system (Visx, Santa Ana, CA, USA) was used to perform the laser ablation in all eyes

Detailed Description:
10 eyes of 10 patients underwent epi-LASK, epithelial flaps were created with the Amadeus II, epi-LASIK-LASIK microkeratome (Ziemer ophthalmics systems AG, Switzerland). A Visx star 4 system (Visx, Santa Ana, CA, USA) was used to perform the laser ablation in all eyes. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients asking for epi-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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00599690


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