A Prospective Study to Evaluate the Feasibility of a New Treatment Algorithm to Increase Depth of Focus After Wavefront-guided LASIK Correction of Myopic Refractive Errors With the iDesign System and Star S4 IR™ Excimer Laser System

Abbott Medical Optics0 sites42 target enrollmentJuly 13, 2016

ConditionsPresbyopia Myopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Presbyopia
Sponsor: Abbott Medical Optics
Enrollment: 42
Primary Endpoint: Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

A prospective study to evaluate the feasibility of a new treatment algorithm to increase depth of focus after wavefront-guided LASIK correction of myopic refractive errors with the iDesign Advanced Wavescan Studio™ System and Star S4 IR™ Excimer Laser System. The purpose of this study is to determine whether wavefront-guided LASIK correction of myopic refractive errors with CustomVue combined with iDesign 1.3-PRESBY (presbyT-LASIK) treatments mitigate the effects of presbyopia by increasing the depth of focus compared to iDesign CustomVue treatments.

Registry

clinicaltrials.gov

Start Date

July 13, 2016

End Date

November 9, 2017

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Medical Optics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All criteria apply to each eye
•Signed informed consent and Personal Health Information Protection Act authorization.
•At least 45 years of age at enrollment (date informed consent signed).
•The refractive error, based on the iDesign displayed refraction selected for treatment ("4.0 Rx calc" at 12.5 mm), must be myopia with or without astigmatism with sphere up to -6.00 D, and cylinder between 0.00 D and -5.00 D with a maximum spherical equivalent (SE) of -8.00 D.
•Require an add power of +1.00 D or more during near testing at 40 cm.
•Anticipated stromal bed thickness of at least 250 microns based on preoperative central corneal pachymetry minus the maximum ablation depth (as calculated by the iDesign system) plus the intended flap thickness.
•Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better.
•Uncorrected Visual Acuity (UCVA) of 20/40 or worse.
•Less than or equal to 0.75 D difference between cycloplegic and manifest refraction sphere.
•A stable refractive error (based on a previous exam, medical records, lensometry, or prescription at least 12 months prior to the preoperative manifest refraction), as defined by a change of ≤1.00 D in MRSE.

Exclusion Criteria

•Women who are pregnant, breast-feeding, intend to become pregnant, or are not using an adequate method of birth control \[examples are any form of barrier contraception (such as condom or diaphragm with contraceptive cream/jelly), birth control pills, hormonal implant, IUD, abstinence or surgical sterilization (tubal ligation, hysterectomy or vasectomy)\]. Note: Women who were pregnant or nursing may not be enrolled until 6 months after either delivery or have stopped nursing and there is documented refractive stability.
•Concurrent use of systemic (including inhaled) medications that may impair healing, including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6 months of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months of treatment.
•NOTE: The use of inhaled or systemic corticosteroids, whether chronic or acute, is deemed to adversely affect healing and subjects using such medications are specifically excluded from eligibility.
•History of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
•NOTE: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity, or control, will specifically exclude subjects from eligibility.
•Subjects with a cardiac pacemaker, implanted defibrillator or other implanted electronic device.
•History of prior intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including, but not limited to, symptomatic blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization \> 1 mm from limbus), retinal detachment/repair, clinically significant lens opacity, clinical evidence of trauma, corneal opacity within the central 9 mm and visible on topography, at risk for developing strabismus, or with evidence of glaucoma or propensity for narrow angle glaucoma.
•NOTE: Subjects with open angle glaucoma, regardless of medication regimen or control, or an IOP greater than 21 mmHg at screening, are specifically excluded from eligibility.
•Evidence of keratoconus, corneal dystrophy or irregularity, or abnormal topography.
•Known sensitivity or inappropriate responsiveness to any of the medications used in the postoperative course.

Outcomes

Primary Outcomes

Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm

Time Frame: 6 months

Mean distance corrected intermediate visual acuity (DCIVA) for presbyT-LASIK treatments (test) was compared to iDesign CustomVue treatments (control).