Prospective S&E Study of Wavefront-guided PRK for Myopia With iDesign Advanced Wavescan Studio™ System and Star S4 IR™

A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-guided PRK Correction of Myopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and the Star S4 IR™ Excimer Laser System

Prospective, multicenter, bilaterally-treated, open-label, non-randomized clinical trial.

Study Overview

• Status: Completed
• Conditions: Stable Myopic Refractive Error, With or Without Astigmatism
• Intervention / Treatment: Device: STAR S4 IR laser with iDesign

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Camp Pendleton, California, United States, 92055
      • Naval Hospital Camp Pendleton
    • San Diego, California, United States, 92106
      • Naval Medical Center
  • Maryland
    • Andrews Air Force Base, Maryland, United States, 20762
      • Warfighter Eye Center Malcolm Grow Medical Clinics and Surgery Center
  • North Carolina
    • Camp Lejeune, North Carolina, United States, 28547
      • Naval Hospital Camp Lejeune
  • Texas
    • El Paso, Texas, United States, 79920
      • William Beaumont Army Medical Center
    • Lackland Air Force Base, Texas, United States, 78236
      • Joint Warfighter Refractive Surgery Center Wilford Hall Medical Center
  • Virginia
    • Portsmouth, Virginia, United States, 23708
      • Naval Medical Center Portsmouth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

NOTE: Enrollment open only to military personnel

Inclusion Criteria:

• Signed informed consent and HIPAA authorization.
• Refractive error, based on the iDesign displayed refraction must be myopia with or without astigmatism with sphere up to -8.00 D, and cylinder between 0.00 D and -4.00 D with maximum SE of -10.00 D.
• Anticipated residual stromal bed thickness of at least 250 microns as calculated by the iDesign system.
• Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
• BSCVA ≥2 lines (≥10 letters) better than distance Uncorrected Visual Acuity (UCVA).
• Less than or equal to 0.75 D difference between cycloplegic and manifest refraction sphere.
• Stable refractive error as defined by a change of ≤1.00 D in MRSE over at least a 12 month time period.
• Any subject eye with a history of contact lens wear within the last 4 weeks must demonstrate refractive stability
• Agreement between manifest refraction (adjusted for optical infinity) and iDesign System refraction chosen for treatment.
• Willing and capable of complying with follow-up examinations for the duration of the study.

Exclusion Criteria:

• Women who are pregnant, breast-feeding, or intend to become pregnant, or not using an adequate method of birth control.
• Concurrent use of systemic (including inhaled) medications that may impair healing.
• 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.
• Subjects with a cardiac pacemaker, implanted defibrillator or other implanted electronic device.
• History of prior intraocular or corneal surgery, active ophthalmic disease or abnormality, 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.
• Evidence of keratoconus, corneal dystrophy or irregularity, or abnormal topography
• Known sensitivity or inappropriate responsiveness to any of the medications used in this study.
• If either eye does not meet all inclusion criteria
• Desire to have monovision.
• Participation in any other clinical study, with the exception of the fellow eye in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: wavefront-guided PRK with iDesign; wavefront-guided PRK for treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser	Device: STAR S4 IR laser with iDesign; Surgeons will perform wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Percentage of Eyes Achieving the Target of Monocular Uncorrected Visual Acuity of 20/40 or Better	At 6 months, UCVA of 20/40 was achieved in 100% (324/324) of eyes monocularly.	6 months

Collaborators and Investigators

• Sponsor: Abbott Medical Optics
• Investigators: Study Director: Johnson & Johnson Surgical Vision Clinical Trials, Johnson & Johnson Surgical Vision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2016
• Primary Completion (Actual): July 27, 2018
• Study Completion (Actual): July 27, 2018

Study Registration Dates

• First Submitted: February 3, 2016
• First Submitted That Met QC Criteria: February 3, 2016
• First Posted (Estimated): February 5, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: myopia
• Additional Relevant MeSH Terms: Eye Diseases; Astigmatism; Refractive Errors
• Other Study ID Numbers: STAR-115-MIPS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes