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Performance and Acceptability of iDesign

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01220466
First received: September 24, 2010
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention
Refractive Error
Device: STAR S4IR LASIK with iDesign Aberrometer

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Study to Evaluate the Performance and Acceptability of the iDesign Advanced WaveScan Study(tm) System

Resource links provided by NLM:


Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Percentage of Eyes With Manifest Refraction Spherical Equivalent Within 1.0 D [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • Percentage of Eyes With Best Spectacle Corrected Visual Acuity (BSCVA) Worse Than 20/40 [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 77
Study Start Date: October 2010
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Refractive Error Device: STAR S4IR LASIK with iDesign Aberrometer
CustomVue LASIK targeted for emmetropia
Other Name: CustomVue

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01220466

Locations
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
Investigators
Study Director: Nicholas Tarantino, OD Abbott Medical Optics
  More Information

No publications provided

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT01220466     History of Changes
Other Study ID Numbers: STAR-108-IDSN
Study First Received: September 24, 2010
Results First Received: February 15, 2013
Last Updated: May 16, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on November 25, 2014