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 range40 Years
SexALL
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)
✓. 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)