N/A
N=20
Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients
Pseudophakia
Bottom Line
View on ClinicalTrials.gov: NCT06064916 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Binocular Best Corrected Distance Visual Acuity — -0.05 logMAR
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Visual Acuity (Diagnostic_test); Defocus Curve (Diagnostic_test); Intraocular Lens Satisfaction (IOLSAT) Questionnaire (Other); Quality of Vision After Surgery (QUVID) Questionnaire (Other); Visual Disturbance Questionnaire (Other); Topography and Tomography (Diagnostic_test)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Berkeley Eye Center
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Binocular Best Corrected Distance Visual Acuity |
-0.05 | — |
| SECONDARY Monocular Visual Acuity |
0.06; 0.18; 0.31; 0.00 | — |
| SECONDARY Binocular Distance, Intermediate, and Near Visual Acuity |
0.02; 0.14; 0.11; 0.24; 0.25 | — |
| SECONDARY Quality of Vision After Surgery (QUVID) Questionnaire |
11; 13; 9; 15; 15; 19 | — |
| SECONDARY Intraocular Lens Satisfaction (IOLSAT) Questionnaire |
16 | — |
| SECONDARY Post-op Refraction |
-0.11 | — |
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.
Eligibility Criteria
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)
- Residual refractive astigmatism ≤0.50 diopters
- 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)
- Optic nerve atrophy
- Subjects with diagnosed degenerative eye disorders
- Postoperative CDVA worse than 0.10 logMAR in either eye.
- Subjects who have an acute or chronic disease or illness that would confound the results of this investigation in the opinion of the principal investigator (e.g. immunocompromised, connective tissue disease, clinically significant atopic disease, etc)
Data sourced from ClinicalTrials.gov (NCT06064916). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.