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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00599690

Enrollment

Registered

2008-01-24

Start date

2006-01-31

Completion date

2007-09-30

Last updated

2024-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Epithelium

Keywords

Epi-LASIK-LASIK microkeratome, Corneal thickness, Confocal microscope

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).

Interventions

PROCEDUREEpi-LASK

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
There are no secondary outcome measures specified for this study	There are no secondary outcome measures specified for this study

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026