Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients (NCT06064916) | Clinical Trial Compass
CompletedNot Applicable
Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients
United States20 participantsStarted 2023-07-25
Plain-language summary
This is a non-interventional, prospective, observational study of the outcomes for post myopic refractive surgery patients following successful, uncomplicated cataract surgery with bilateral implantation of the Vivity IOL (DAT\*\*\*/CCWET\*).
Patients will be assessed for monocular and binocular distance, intermediate, and near vision.
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
. Adults, 40 years of age having already undergone cataract removal by phacoemulsification with a clear corneal incision in both eyes with implantation of the Vivity IOL (DAT\*\*\*/CCWET\*)
. Prior uncomplicated, distance-targeted, bilateral myopic LASIK or PRK (photorefractive keratectomy) surgery and corneal spherical aberration greater than ≥0.30 μ and ≤ 1.20 μ in at least one eye (6.00 mm) as measured at their cataract pre-op visit
. Able to comprehend and willing to sign informed consent and complete all required testing procedures
. Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.10 logMAR (Minimum Angle of Resolution) or better
. Clear intraocular media
. Minimum of two weeks post YAG (yttrium aluminum garnet) capsulotomy to treat PCO (posterior capsular opacification)
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.
. Post-operative refractive spherical equivalent from +0.50 to -0.50 spherical equivalent
Exclusion criteria
. Any corneal abnormality, other than regular corneal astigmatism or myopic LASIK/PRK surgery, (as determined by pre-operative testing) that in the opinion of the investigator would confound the outcome(s) of the study
. Any complication during cataract surgery (capsular tear, vitrectomy, etc)
. History of or current retinal conditions or predisposition to retinal conditions or predisposition to retinal conditions
. Amblyopia or strabismus in either eye
. History of or current anterior or posterior segment inflammation of any etiology
. Any form of neovascularization on or within the eye
. Glaucoma (uncontrolled or controlled with medication)