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

Not Applicable

Terminated

• Conditions: Corneal Epithelium
• Interventions: Procedure: Epi-LASK

• Registration Number: NCT00599690
• Lead Sponsor: Asociación para Evitar la Ceguera en México

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 Timeline

• Study Start: 2006-01
• Primary Completion: 2006-01
• Study Completion: 2007-09
• Study First Submitted: 2008-01-08
• Study First Submitted QC: 2008-01-23
• Study First Posted: 2008-01-24
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	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

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcome measures specified for this study	There are no secondary outcome measures specified for this study

Trial Locations

Locations (1)

Asociación Para Evitar la Ceguera en Mëxico, Hospital "Luis Sánchez Bulnes".; 🇲🇽 Mexico city, Distrito Federal, Mexico