Completed

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

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What is being tested

LASIK correction of myopic refractive errors

Device
Who is being recruted

Eye Diseases

+ Refractive Errors

+ Myopia

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorAbbott Medical Optics
Last updated: February 4, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

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

NCT01663363
Principal SponsorAbbott Medical Optics
Last updated: February 4, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

170 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesRefractive ErrorsMyopia

Criteria

7 inclusion criteria required to participate
18 years of age or greater
Anticipated post-operative stromal bed thickness of at least 250 microns
Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
Demonstration of refractive stability
Show More Criteria
6 exclusion criteria prevent from participating
Concurrent use of topical or systemic medications that may impair healing
Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s)
History of any medical conditions that could affect wound healing
History of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
LASIK correction of myopic refractive errors. Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers