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

Tracking Information

First Received Date ^ICMJE

January 8, 2008

Last Updated Date

January 28, 2008

Start Date ^ICMJE

January 2006

Primary Completion Date

January 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00599690 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

There are no secondary outcome measures specified for this study [ Time Frame: There are no secondary outcome measures specified for this study ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

To evaluate the confocal microscopy findings at the corneal epithelium and anterior stroma after epi-LASIK Surgery.

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).

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Screening, Open Label, Uncontrolled, Single Group Assignment

Condition ^ICMJE

Corneal Epithelium

Intervention ^ICMJE

Procedure: Epi-LASK

Study Arms / Comparison Groups

Experimental: 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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2007

Primary Completion Date

January 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Mexico

Administrative Information

NCT ID ^ICMJE

NCT00599690

Responsible Party

Asociación para Evitar la Ceguera en México, Asociación para Evitar la Ceguera en México

Study ID Numbers ^ICMJE

Cornea 3, No

Study Sponsor ^ICMJE

Asociación para Evitar la Ceguera en México

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Ramirez F Manuel, MD

APEC

Information Provided By

Asociación para Evitar la Ceguera en México

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP