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

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ClinicalTrials.gov Identifier: NCT04075591
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : May 13, 2021
Sponsor:
Information provided by (Responsible Party):
AMO Development, LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Refractive Error Device: iDesign Refractive Studio with STAR S4 IR® Excimer laser System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 383 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: wavefront-guided LASIK monovision treatment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Post-approval Study of Wavefront-guided LASIK for Monovision Treatment of Myopic Subjects With Presbyopia
Actual Study Start Date : September 24, 2019
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Wavefront-guided Lasik Monovision Treatment
Wavefront-guided LASIK monovision treatment of myopic subjects with presbyopia using the STAR S4 IR® Excimer laser System with the iDesign Refractive Studio.
Device: iDesign Refractive Studio with STAR S4 IR® Excimer laser System
Surgeons will perform wavefront-guided monovision LASIK for the treatment of myopic subjects with presbyopia based upon measurements obtained with an iDesign Refractive Studio.




Primary Outcome Measures :
  1. The change in driving scale score from preoperative to postoperative as measured by the driving scale within the PROWL-M (Patient-Reported Outcomes with LASIK for monovision) questionnaire [ Time Frame: 12 months ]
    To assess the effect of monovision LASIK treatment on difficulty with driving as measured by the driving scale within the PROWL-M (Patient-Reported Outcomes with LASIK for monovision) questionnaire

  2. The proportion of subjects who required secondary surgery to reverse monovision [ Time Frame: 12 months ]
    The proportion of subjects who required secondary surgery to reverse monovision will be reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  10. Subjects with a history of contact lens wear within the last 4 weeks must discontinue lens wear in order to demonstrate refractive stability according to the following (refractive stability is defined as a change of not more than 0.50 D in manifest refraction sphere and cylinder as well as mean keratometry between measurements): After the Informed Consent process has been completed and subjects are enrolled in the study:

    • Rigid or extended wear contact lenses (toric or spherical) must be removed for at least 3 weeks and soft contact lenses (toric or spherical) for at least 2 weeks prior to the first refraction used to establish stability.
    • After abstaining from contact lens wear for designated time, two consecutive manifest refractions and keratometric readings must be conducted at least 7 days apart
    • I If the subject/eye meets the refractive stability criteria, contact lens wear is not permitted for 2 weeks prior to surgery except as required to test monovision acceptance as described below in the Study Procedures, Contact Lens Trial section NOTE: Refractive stability needs to be confirmed only once during preoperative assessment
  11. Agreement between manifest refraction (adjusted for optical infinity) and iDesign System refraction chosen for treatment, as follows:

    • Spherical Equivalent: magnitude of the difference is less than 0.625 D.
    • Cylinder: magnitude of the difference is less than or equal to 0.5 D.
    • Cylinder Axis Tolerance: If either the manifest cylinder entered into the iDesign System or the iDesign cylinder selected for treatment is less than 0.5 D, there is no requirement for axis agreement. When both cylinders have a magnitude of at least 0.5 D, the axis tolerance as determined by the iDesign system is linearly reduced from 15 degrees (0.5 D) to 7.5 degrees (7.0 D) based on the average magnitude of both cylinders. Note: If the axis tolerance is not in the calculated range, the iDesign system will produce a warning and this exam may not be used for treatment planning.
  12. Willing and capable of complying with follow-up examinations for the duration of the study.

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.
  8. Intolerance to monovision correction based on questionnaire responses to contact lens trial (refer to section Study Procedures, Contact Lens Trial below).
  9. Concurrent participation in any other clinical trial, or participation in any other clinical trial within the last 14 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075591


Contacts
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Contact: Audrey Jonas +1 408 2734073 ajonas4@ITS.JNJ.com

Locations
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United States, Arizona
Schwartz Laser Eye Center Not yet recruiting
Scottsdale, Arizona, United States, 85260
United States, California
Maloney Vision Institute Not yet recruiting
Los Angeles, California, United States, 90024
United States, Illinois
Kraff Eye Institute Recruiting
Chicago, Illinois, United States, 60602
United States, New Mexico
Coleman Vision Active, not recruiting
Albuquerque, New Mexico, United States, 87109
United States, South Dakota
Vance Thompson Vision Recruiting
Sioux Falls, South Dakota, United States, 57108
United States, Tennessee
Loden Vision Centers Recruiting
Goodlettsville, Tennessee, United States, 37072
United States, Texas
Berkeley Eye Institute, P.A. Recruiting
Houston, Texas, United States, 77027
Texas Eye & Laser Center Recruiting
Hurst, Texas, United States, 76054
United States, Utah
Utah Eye Center Recruiting
Ogden, Utah, United States, 84403
United States, Virginia
The Eye Center Recruiting
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
AMO Development, LLC
Investigators
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Study Director: Johnson & Johnson Surgical Vision Inc. Clinical Trial Johnson & Johnson Surgical Vision, Inc.
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Responsible Party: AMO Development, LLC
ClinicalTrials.gov Identifier: NCT04075591    
Other Study ID Numbers: STAR-122-MVPM
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
URL: http://yoda.yale.edu/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases