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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00558324

Enrollment

Registered

2007-11-14

Start date

2007-02-28

Completion date

2007-10-31

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

Refractive Errors

Keywords

LASIK, Confocal microscopy, Flap

Brief summary

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

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).

Interventions

PROCEDURELASIK

Mechanical microkeratome Hansatome 160 microns

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Measured thickness flap using Confocal microscopy study	14 days after LASIK

Countries

Mexico

Outcome results

None listed

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