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Clinical Trials/NCT01298089
NCT01298089CompletedNot Applicable

LASIK Flap Thickness Predictability With the Carriazo Pendular Microkeratome

Democritus University of Thrace1 site in 1 country131 target enrollmentStarted: February 2006Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
131
Locations
1
Primary Endpoint
Corneal flap thickness (micrometers)

Study Overview

Brief Summary

A study of flap thickness predictability in patients submitted to Laser in Situ Keratomileusis (LASIK) with the Carriazo-Pendular microkeratome (130 micrometers head size).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • LASIK candidates treated with the Carriazo-Pendular microkeratome - 130 micron head

Exclusion Criteria

  • corneal irregularities > 3D
  • Thin corneal CCT < 460μm
  • Active anterior segment disease
  • Previous intraocular or corneal surgery
  • History of herpetic eye disease
  • Corneal scarring
  • Severe dry eye
  • Topographic evidence of keratoconus

Outcomes

Primary Outcomes

Corneal flap thickness (micrometers)

Time Frame: 6 months postoperatively

Flap thickness was calculated by subtracting the preoperative central corneal thickness minus the intraoperative residual stromal thickness. All measurements were made using ultrasound pachymetry (non-interventional technique).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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