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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075591
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Surgical Vision, Inc.

Brief Summary:
This study will be a 12-month, prospective, multicenter, open-label, non-comparative, non-randomized clinical investigation conducted at 10 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 : May 31, 2022
Estimated Study Completion Date : May 31, 2022

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Signed informed consent and HIPAA authorization.
  • At least 40 years of age at enrollment (date informed consent signed).
  • The refractive error (i.e. prescription) of both eyes, based on the iDesign system must be myopic with astigmatism up to -6.00 D spherical equivalent (SE), with astigmatism up to -3.00 D and minimum pre-operative myopia in their non-dominant eye at least as great as their targeted myopic retention.
  • At least one eye must require a myopic (nearsightedness) treatment.
  • Your distance vision must be 20/20 or better
  • Require an add power of +1.25 D or more but not greater than +2.00 D at 40 cm.
  • You have a history of contact lens wear within the last 4 weeks must demonstrate stable corrected vision
  • Rigid contact lenses must be removed for at least 4 weeks and soft contact lenses for at least 2 weeks prior to the first refraction used to establish stability.
  • If you meet the refractive stability criteria, contact lens wear is not permitted prior to surgery except as required to test monovision acceptance as described below in the Study Procedures, Contact Lens Trial section
  • Willing and capable of complying with follow-up examinations for the duration of the study.

Exclusion Criteria:

  • You are pregnant, breast-feeding, or intend to become pregnant during the study.
  • 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.
  • 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.
  • You have a cardiac pacemaker, implanted defibrillator or other implanted electronic device.
  • History of prior intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality.
  • Evidence of keratoconus, corneal dystrophy or irregularity, or abnormal topography.
  • Known sensitivity or inappropriate responsiveness to any of the medications used in the postoperative course.
  • Intolerance to monovision correction based on questionnaire responses to contact lens trial.
  • Participation in any other clinical study.

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: Cheryl Mckinnon +1 408 2734014 CMcKinno@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 Not yet 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
Johnson & Johnson Surgical Vision, Inc.
Investigators
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Study Director: Sanjeev Kasthurirangan, Ph.D. Johnson & Johnson Surgical Vision, Inc.
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Responsible Party: Johnson & Johnson Surgical Vision, Inc.
ClinicalTrials.gov Identifier: NCT04075591    
Other Study ID Numbers: STAR-122-MVPM
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
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