IntraLase vs Hansatome Flaps in LASIK

Comparison of the IntraLaser Femtosecond Laser and Hansatome Mechanical Keratome for Laser In Situ Keratomileusis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00691431

Enrollment

Registered

2008-06-05

Start date

2004-05-31

Completion date

2005-11-30

Last updated

2011-06-02

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

Conditions

Myopia

Brief summary

This study compared the clinical outcomes between fellow eyes randomized to either IntraLase femtosecond laser-created flaps or Hansatome mechanical keratome-created flaps during wavefront-guided laser in situ keratomileusis.

Interventions

DEVICELASIK

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Inclusion criteria were T 6.00 D of spherical myopia, T 3.00 D of refractive astigmatism, stable refraction (less than 0.50D per year of sphere or cylinder), corneal diameter less than 11.0 mm to allow for suction fixation ring, soft contact wearer with discontinuation of wear at least 7 days prior to preoperative evaluation, visual acuity correctable to at least 20/20 in both eyes, more than 21 years of age, ability to participate in follow-up examinations for 12 months after LASIK surgery. In order to fairly compare the visual outcomes of the two keratomes, patients were required to have closely matched eyes, in terms of refractive error.

Design outcomes

Primary

Measure	Time frame
Visual acuity	—

Secondary

Measure	Time frame
Contrast sensitivity	—

Countries

United States

Outcome results

None listed

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