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OpenTrials
Completed

NCT Number: NCT01675479

Safety and Effectiveness of Wavefront-Guided LASIK Correction of Hyperopic Refractive Errors

Demonstrate that wavefront-guided LASIK using measurements from the iDesign System is safe and effective for the treatment of Hyperopia.

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Key information

Conditions

Hyperopia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maloney Vision Institute, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • At least 18 years of age at the time of pre-operative exam
  • Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
  • 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 hyperopic refractive errors

Device

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

Primary outcomes

  1. Number of Eyes With a Loss of >2 Lines for Best Spectacle Corrected Visual Acuity (BSCVA)

    Time frame: 12 Months

    Hypothesis: <5% of eyes will have a loss of > 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters

Secondary outcomes

  1. Number of Eyes With Uncorrected Visual Acuity (VA) of 20/40 or Better

    Time frame: 12 Months

    Hypothesis: 85% of eyes will have uncorrected visual acuity of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters

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 Hyperopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and Star S4 IR™ Excimer Laser System

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Aug 30, 2012
Registry last updated
Dec 15, 2021

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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