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Clinical Trials/NCT00558324
NCT00558324TerminatedNot Applicable

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

Asociación para Evitar la Ceguera en México1 site in 1 country43 target enrollmentStarted: February 1, 2007Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
43
Locations
1
Primary Endpoint
Measured thickness flap using Confocal microscopy study

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

II

Experimental

Corneal flaps were created with mechanical microkeratome K3000 130μm ( BD Ophthalmic Systems, Waltham, Mass) .

Intervention: LASIK (Procedure)

III

Experimental

Corneal flaps were created with microkeratome femtoseconds laser (Intralase Corp, Irvine, Calif.)

Intervention: LASIK (Procedure)

I

Experimental

Corneal flaps were created with mechanical microkeratome (Hansatome 160μm (Chiron Vision Corp, Claremont, Calif)

Intervention: LASIK (Procedure)

Outcomes

Primary Outcomes

Measured thickness flap using Confocal microscopy study

Time Frame: 14 days after LASIK

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Asociación para Evitar la Ceguera en México
Sponsor Class
Other

Study Sites (1)

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