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

NCT ID: NCT02675751

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-03
• Study Completion Date: 2018-07-27

Brief Summary

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

Conditions

Stable Myopic Refractive Error, With or Without Astigmatism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

STAR S4 IR laser with iDesign

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Optics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Surgical Vision Clinical Trials

Role: STUDY_DIRECTOR

Johnson & Johnson Surgical Vision, Inc.

References

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.

Reference Type: DERIVED

PMID: 36730946 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

STAR-115-MIPS

Identifier Type: -

Identifier Source: org_study_id