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OpenTrials
Completed

NCT Number: NCT01663363

Safety and Effectiveness of Wavefront-Guided LASIK Corrections of Myopic Refractive Errors

The purpose of this clinical trial is to demonstrate that wavefront-guided LASIK is safe and effective for the correction of myopic refractive errors.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or greater
  • Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
  • Uncorrected visual acuity (UCVA) of 20/40 or worse
  • Less than 0.75D difference between cycloplegic and manifest refraction sphere.
  • Demonstration of refractive stability
  • Anticipated post-operative stromal bed thickness of at least 250 microns
  • Willing and capable of returning for follow-up examinations for the duration of the study.

Exclusion criteria

  • Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study
  • Concurrent use of topical or systemic medications that may impair healing
  • History of any medical conditions that could affect wound healing
  • History of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality
  • Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s)
  • Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course

Treatment and study plan

LASIK correction of myopic refractive errors

Device

Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System

Primary outcomes

  1. Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)

    Time frame: 6 Months

Secondary outcomes

  1. Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better

    Time frame: 6 Months

Sponsors and collaborators

Lead sponsor

Abbott Medical Optics

Industry

Registry information

Official study title

A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided LASIK Correction of Myopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and Star S4IR™ Excimer Laser

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Aug 13, 2012
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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