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

NCT02675751 | Completed Results FDA Device

• 1 other identifier: STAR-115-MIPS
• Study Type: interventional
• Target: 167
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Stable Myopic Refractive Error, With or Without Astigmatism

Keywords

myopia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

wavefront-guided PRK with iDesign

EXPERIMENTAL

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

Interventions

STAR S4 IR laser with iDesign DEVICE

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.

wavefront-guided PRK with iDesign

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Desire to have monovision.
• Participation in any other clinical study, with the exception of the fellow eye in this study.

Sponsors & Collaborators

• Abbott Medical Optics: lead

Related Publications (1)

• Hofmeister EM, Cason JB, Murdoch DM, Yau IW, Wang Y, Parizadeh DD, Janakiraman DP, Kasthurirangan S. Wavefront-guided PRK treatment of myopia using a refractive aberrometer. J Cataract Refract Surg. 2023 Mar 1;49(3):292-298. doi: 10.1097/j.jcrs.0000000000001083.

  PMID: 36730946 DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Sanjeev Kasthurirangan Ph.D.
• Organization: Johnson & Johnson Surgical Vision

skasthur@its.jnj.com

+1 408-273-4081

Study Officials

• Johnson & Johnson Surgical Vision Clinical Trials

  Johnson & Johnson Surgical Vision, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: February 5, 2016
• Study Start: February 3, 2016
• Primary Completion: July 27, 2018
• Study Completion: July 27, 2018
• Last Updated: February 4, 2025
• Results First Posted: September 24, 2019

Record last verified: 2025-01