Overview

Johnson & Johnson Surgical Vision, Inc. is holding a study treating refractive errors in eyes with wavefront-guided LASIK monovision treatment, specifically titled iDesign Refractive Studio with STAR S4 IR® Excimer laser System. The surgery will be performed on myopic (nearsighted) subjects with presbyopia (farsightedness). 

Study Information

There is an estimated enrollment of 383 participants. Researchers will investigate how difficult it is for participants to drive using a Patient-Reported Outcomes with LASIK for monovision (PROWL-M) questionnaire. This questionnaire will be given 12 months after surgery. 

Inclusion Criteria

All sexes, ages 40 and older, are allowed to participate. Other inclusion criteria are:

• Signed informed consent and HIPAA authorization.
• The refractive error (i.e. prescription) of both eyes..
• At least one eye must require a myopic (nearsightedness) treatment.
• 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
• 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.
• Contact lens wear is not permitted prior to surgery
• Willing and able to comply with follow-up examinations for the duration of the study.

Exclusion Criteria

• 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: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.
• 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.
• Enrolled in any other clinical study.

Location

Those interested may participate in this study at:

• Maloney Vision Institute in Los Angeles, California, 90024 
• Kraff Eye Institute in Chicago, Illinois, 60602
• Coleman Vision in Albuquerque, New Mexico, 87109
• Loden Vision Centers in Goodlettsville, Tennessee, 37072
• The Eye Center in Fairfax, Virginia, 22031

Feel free to contact Leilei Ji, MD at 408-273-5933 or at LJi4@its.jnj.com with any questions or concerns.

Sponsors/Collaborators

This clinical trial is sponsored by Johnson & Johnson Surgical Vision, Inc. The Study Director is Sanjeev Kasthurirangan, Ph.D.