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Wavefront-guided LASIK for Monovision Treatment of Myopic Subjects With Presbyopia | Clinical Trials | Clareo Health

COMPLETEDNA

Wavefront-guided LASIK for Monovision Treatment of Myopic Subjects With Presbyopia

Post-approval Study of Wavefront-guided LASIK for Monovision Treatment of Myopic Subjects With Presbyopia

NCT04075591•AMO Development, LLC

Summary

This study will be a 12-month, prospective, multicenter, open-label, non-comparative, non-randomized clinical investigation conducted at 8 to 14 sites. A total of 383 subjects will be enrolled to achieve approximately 268 treated subjects, resulting in at least 241 evaluable subjects at the point of refractive stability. After signing the informed consent, subjects meeting all inclusion and exclusion criteria in both eyes may be scheduled for surgery. The follow-up visit schedule will be the same for each operative eye.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed informed consent and HIPAA authorization.
•2. At least 40 years of age at enrollment (date informed consent signed).
•3. The refractive error of both subject's eyes, based on the iDesign refraction selected for treatment ("4.0 mm Rx calc" at 12.5 mm), must be myopic with or without astigmatism up to -6.00 D spherical equivalent (SE), with cylinder up to -3.00 D and minimum pre-operative myopia in their non-dominant eye at least as great as their targeted myopic retention.
•4. At least one eye must require a myopic treatment.
•5. Anticipated stromal bed thickness of at least 250 microns based on preoperative central corneal pachymetry minus the maximum treatment depth to be ablated (as calculated by the iDesign plus the intended flap thickness).
•6. Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better.
•7. Require an add power of +1.25 D or more but not greater than +2.00 D at 40 cm.
•8. Less than or equal to ±0.50 D difference between cycloplegic and manifest refraction sphere.
•9. A stable refractive error (based on a previous exam, medical records, lensometry, or prescription that is at least 12 months prior to the preoperative manifest refraction), as defined by a change of less than or equal to
•* 0.50 D in MRSE (sphere and cylinder).
+9 more criteria

Exclusion Criteria

•1. Women who are pregnant, breast-feeding, or intend to become pregnant during the study.
•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.
•2. 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, within the past 6 months is deemed to adversely affect healing and subjects using such medications are specifically excluded from eligibility.
•3. 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.
•4. Subjects with a cardiac pacemaker, implanted defibrillator or other implanted electronic device.
•5. 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, prior strabismus surgery, strabismus, or at risk for developing strabismus, or with evidence of glaucoma or propensity for narrow angle glaucoma or suspected glaucoma.
•NOTE: Subjects with glaucoma, regardless of medication regimen or control, or an IOP greater than 21 mmHg at screening, are specifically excluded from eligibility.
•6. Evidence of keratoconus, corneal dystrophy or irregularity, or abnormal topography.
•7. Known sensitivity or inappropriate responsiveness to any of the medications used in the postoperative course.
+2 more criteria

Locations (10)

Maloney Vision Institute

Los Angeles, California, United States

Kraff Eye Institute

Chicago, Illinois, United States

Center for Sight

Las Vegas, Nevada, United States

Coleman Vision

Albuquerque, New Mexico, United States

Vance Thompson Vision

Sioux Falls, South Dakota, United States

Loden Vision Centers

Goodlettsville, Tennessee, United States

Berkeley Eye Institute, P.A.

Houston, Texas, United States

Texas Eye & Laser Center

Hurst, Texas, United States

Utah Eye Center

Ogden, Utah, United States

The Eye Center

Fairfax, Virginia, United States

Key Dates

Start Date

September 24, 2019

Primary Completion Date

June 25, 2025

Completion Date

June 25, 2025

Last Updated

July 23, 2025

Enrollment

219

ACTUAL participants

Conditions

Refractive Error

Interventions

iDesign Refractive Studio with STAR S4 IR® Excimer laser System

DEVICE

Cognitive Level Enhancement Through Vision Exams and Refraction

NCT05458323

Refractive Errors

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RECRUITING

Clinical Data Collection of Myopic Patients After PTK-PRK With CZM MEL 90 Excimer Laser

NCT06996353

Refractive Errors

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RECRUITINGNA

Optimizing Light Exposure for Myopia Prevention and Control (LightSPAN)

NCT06631339

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Wavefront-guided LASIK for Monovision Treatment of Myopic Subjects With Presbyopia

Inclusion Criteria

Exclusion Criteria

Cognitive Level Enhancement Through Vision Exams and Refraction

Clinical Data Collection of Myopic Patients After PTK-PRK With CZM MEL 90 Excimer Laser

Optimizing Light Exposure for Myopia Prevention and Control (LightSPAN)

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