Performance and Acceptability of iDesign

Refractive Error Clinical Trial

Official title:

A Prospective Study to Evaluate the Performance and Acceptability of the iDesign Advanced WaveScan Study(tm) System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220466
• Other study ID #: STAR-108-IDSN
• Status: Completed
• Phase: N/A
• First received: September 24, 2010
• Last updated: May 16, 2013
• Start date: October 2010
• Est. completion date: December 2011

Study information

• Verified date: May 2013
• Source: Abbott Medical Optics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• STAR S4IR LASIK with iDesign Aberrometer
CustomVue LASIK targeted for emmetropia

Locations

Country	Name	City	State
Canada	University of Ottawa Eye Institute, The Ottawa Hospital	Ottawa	Ontario
Canada	Yonge-Eglington Laser	Toronto	Ontario
Canada	Clearly LASIK	Victoria	British Columbia
Canada	Image Plus Laser Eye Center	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Optics

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Eyes With Manifest Refraction Spherical Equivalent Within 1.0 D		6 months	No
Other	Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)		6 Months	Yes
Other	Percentage of Eyes With Best Spectacle Corrected Visual Acuity (BSCVA) Worse Than 20/40		6 Months	Yes
Other	Percentage of Eyes With Induced Manifest Refractive Astigmatism Greater Than 2.00 D of Absolute Cylinder as Compared to the Preoperative Refraction	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.	6 Months	Yes
Primary	Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better.		6 months	No