Wavefront-guided LASIK for Monovision Treatment of Myopic Subjects With Presbyopia (NCT04075591) | Clinical Trial Compass
CompletedNot Applicable
Wavefront-guided LASIK for Monovision Treatment of Myopic Subjects With Presbyopia
United States219 participantsStarted 2019-09-24
Plain-language 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed informed consent and HIPAA authorization.
. At least 40 years of age at enrollment (date informed consent signed).
. 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.
. At least one eye must require a myopic treatment.
. 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).
. Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Driving Scale Score From Preoperative to Postoperative as Measured by Driving Scale Within Patient-Reported Outcomes With LASIK for Monovision (PROWL-M)
Timeframe: From preoperative (within 120 to 14 days prior to surgery on Day 0) to 12 month postoperative (operated on Day 0)
2
Percentage of Participants Who Required Secondary Surgery to Reverse Monovision
Timeframe: At 12 month postoperative (operated on Day 0)
. Require an add power of +1.25 D or more but not greater than +2.00 D at 40 cm.
. Less than or equal to ±0.50 D difference between cycloplegic and manifest refraction sphere.
Exclusion criteria
. Women who 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. 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.
. 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 (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.
. 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 (refer to section Study Procedures, Contact Lens Trial below).