Status:

COMPLETED

Comparison of Intralase and Visumax Femtosecond Laser for Laser In Situ Keratomileusis

Lead Sponsor:

Singapore Eye Research Institute

Conditions:

Myopia

Eligibility:

All Genders

21-60 years

Brief Summary

Emtosecond lasers are used in cutting the flap in LASIK procedures (laser corrective surgery for refractive error). Their use has decreased the incidence of serious complications when compared to the ...

Eligibility Criteria

Inclusion

  • 21 years of age or older.
  • Cycloplegic spherical equivalent of \>-1.00D
  • Refractive cylinder -4.00 D or less.
  • Best spectacle corrected visual acuity (BSCVA) of 6/12 or better in BOTH eyes.
  • Spherical or cylindrical error has progressed at -0.50D or less per year from date of baseline measurement.
  • Contact lens wearers must have removed contact lenses at least two (2) weeks before the baseline measurement.
  • No evidence of irregular astigmatism on corneal topography.
  • Available to attend post-operative examinations for a 3 month period.

Exclusion

  • Progressive or unstable myopia and/or astigmatism.
  • Clinical or corneal topographic evidence of keratoconus.
  • Residual, recurrent or active ocular disease such as uveitis, severe dry eyes, severe allergic eye disease, glaucoma, visually significant cataract and retinal disease.
  • Previous corneal surgery or trauma within the corneal flap zone.
  • Patent corneal vascularization within 1mm of the corneal flap zone.
  • Taking systemic medications likely to affect wound healing, such as corticosteroids and antimetabolites.
  • Systemically immunocompromised.
  • Systemic disease likely to affect wound healing, such as diabetes, connective tissue disease and severe atopy.
  • Pregnant or nursing.

Key Trial Info

Start Date :

January 1 2010

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 1 2013

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT01252654

Start Date

January 1 2010

End Date

August 1 2013

Last Update

July 20 2016

Active Locations (1)

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Singapore National Eye Centre

Singapore, Singapore, 168751