Performance and Acceptability of iDesign

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01220466
Recruitment Status : Completed
First Posted : October 14, 2010
Results First Posted : May 20, 2013
Last Update Posted : May 20, 2013
Information provided by (Responsible Party):
Abbott Medical Optics

Brief Summary:
The results of this trial will demonstrate that the iDesign System performs as intended and is acceptable in a clinical setting.

Condition or disease Intervention/treatment Phase
Refractive Error Device: STAR S4IR LASIK with iDesign Aberrometer Not Applicable

Detailed Description:
LASIK treatment across the range of myopia with or without astigmatism, hyperopia with or without astigmatism, and mixed astigmatism.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study to Evaluate the Performance and Acceptability of the iDesign Advanced WaveScan Study(tm) System
Study Start Date : October 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Refractive Error Device: STAR S4IR LASIK with iDesign Aberrometer
CustomVue LASIK targeted for emmetropia
Other Name: CustomVue

Primary Outcome Measures :
  1. Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better. [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Percentage of Eyes With Manifest Refraction Spherical Equivalent Within 1.0 D [ Time Frame: 6 months ]
  2. Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) [ Time Frame: 6 Months ]
  3. Percentage of Eyes With Best Spectacle Corrected Visual Acuity (BSCVA) Worse Than 20/40 [ Time Frame: 6 Months ]
  4. Percentage of Eyes With Induced Manifest Refractive Astigmatism Greater Than 2.00 D of Absolute Cylinder as Compared to the Preoperative Refraction [ Time Frame: 6 Months ]
    Induced Manifest Refractive Astigmatism is an increase of astigmatism (cylinder) postoperatively that could be caused by the refractive treatment. An increase of greater than 2.0 D is considered a safety endpoint per ANSI Z80.11-2007.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female, of any race, and at least 18 years old at the time the consent form is signed.
  • The refractive error, based on manifest refraction (adjusted for optical infinity), must be MRSE up to -15.00 D with manifest cylinder between 0.00 and -6.00 D; MRSE up to +9.00 D with cylinder between 0.00 and +6.00 D; or manifest cylinder (from 1.00 to 6.00 D) greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
  • BSCVA of 20/20 or better.
  • UCVA:

    • Myopes must be 20/40 or worse.
    • Subjects with Hyperopia or mixed astigmatism, treatment may be based on difficulty maintaining UCVA of 20/40 evidenced by spectacle/contact lens dependence for distance, as documented by the investigator.
  • Wavefront diameter ≥ 4.0 mm.
  • Sufficient agreement between manifest refraction (adjusted for optical infinity) and iDesign System refraction (sphere, cylinder, and axis) to allow treatment selection and generation of an ablation profile as determined by the investigational iDesign System software.
  • Manifest refraction sphere within ± 0.75 D of cycloplegic refraction sphere.
  • Anticipated post-operative stromal bed thickness of at least 250 microns, based on pre-operative central corneal pachymetry minus the maximum treatment depth to be ablated (as calculated by the iDesign System) and the intended flap thickness.
  • Anticipated post-operative keratometry value (based on pre-operative iDesign System refraction and keratometry) that is appropriate.
  • A stable refractive error (based on a previous exam, medical records, or prescription) as compared to the unadjusted pre-operative manifest refraction.
  • Subjects who currently wear contact lenses must demonstrate refractive stability in the operative eye. Rigid or toric lenses must be removed for at least 2 weeks and SCL for at least 3 days prior to the first refraction used to establish stability. A second refraction with a change of no more than ± 0.50 D MRSE at least 7 days after baseline.
  • 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, as determined by verbal inquiry, or another condition associated with the fluctuation of hormones that could lead to refractive changes.
  • Subjects with an ametropic or amblyopic fellow eye not meeting all inclusion criteria that does not fall within the indications for treatment using the VISX® STAR S4 IR™ Excimer Laser.
  • Concurrent use of systemic (including inhaled) medications that may impair healing, including but not limited to: steroids, antimetabolites, isotretinoin (Accutane™) within 6 months of treatment, and amiodarone hydrochloride (Cordarone™) within 12 months of treatment.
  • Acute or chronic disease, illness, or treatment that would increase the operative risk (e.g., immuno-compromised, autoimmune disease, connective tissue disease, clinically significant atopic disease, diabetes, etc.).
  • Subjects with a cardiac pacemaker, implanted defibrillator, implanted neurostimulator, or any active electrical implants.
  • Ocular condition (other than high myopia) that may predispose the subject to future complications, such as history or evidence of active or inactive corneal disease
  • Previous intraocular or corneal surgery that might confound the outcome of the study or increase risk to the subject.
  • Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
  • Concurrent participation in any other clinical study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01220466

Canada, British Columbia
Clearly LASIK
Victoria, British Columbia, Canada, V8X 1X2
Canada, Manitoba
Image Plus Laser Eye Center
Winnipeg, Manitoba, Canada, R3C 3J5
Canada, Ontario
University of Ottawa Eye Institute, The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Yonge-Eglington Laser
Toronto, Ontario, Canada, M4P 2E5
Sponsors and Collaborators
Abbott Medical Optics
Study Director: Nicholas Tarantino, OD Abbott Medical Optics

Responsible Party: Abbott Medical Optics Identifier: NCT01220466     History of Changes
Other Study ID Numbers: STAR-108-IDSN
First Posted: October 14, 2010    Key Record Dates
Results First Posted: May 20, 2013
Last Update Posted: May 20, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases