Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a non-interventional, prospective, single center, bilateral, observational study of the outcomes for 40 post myopic refractive surgery patients following successful, uncomplicated cataract surgery with bilateral implantation of the Vivity IOL (DAT***/CCWET*) performed by 4 surgeons using similar surgical techniques. 40 subjects will be enrolled. Patients will be assessed for monocular and binocular distance, intermediate, and near vision. The hypothesis is that post-refractive patients that have high spherical aberration (SAs) will have excellent outcomes and satisfaction with a Vivity IOL

Official Title
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Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients

Conditions
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Pseudophakia

Intervention / Treatment
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* Diagnostic Test: Visual Acuity
* Diagnostic Test: Defocus Curve
* Other: Intraocular Lens Satisfaction (IOLSAT) Questionnaire
* Other: Quality of Vision After Surgery (QUVID) Questionnaire
* Other: Visual Disturbance Questionnaire
* Diagnostic Test: Topography and Tomography


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vivity IOL Group<br>Patients with bilateral implantation of Vivity IOLs. | Diagnostic Test: Visual Acuity<br>* Monocular and binocular measurement of distance, intermediate, and near visual acuity<br>Diagnostic Test: Defocus Curve<br>* Measurement of a defocus curve<br>Other: Intraocular Lens Satisfaction (IOLSAT) Questionnaire<br>* Self-reported post-operative patient satisfaction with vision after surgery<br>Other: Quality of Vision After Surgery (QUVID) Questionnaire<br>* Self-reported post-operative patient vision quality after surgery<br>Other: Visual Disturbance Questionnaire<br>* Questionnaire of self-reported visual disturbances of patients<br>Diagnostic Test: Topography and Tomography<br>* Topography and tomography measurements with Atlas, iTrace, and/or Pentacam<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular Best Corrected Distance Visual Acuity | Binocular Best Corrected Distance Visual Acuity | 3 weeks post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular vision | Monocular UCDVA (uncorrected distance visual acuity), UCIVA (uncorrected intermediate visual acuity), UCNVA (uncorrected near visual acuity), and BCDVA (best corrected distance visual acuity) | 3 weeks post operatively | 
| Binocular distance, intermediate, and near visual acuity | Binocular distance, intermediate, and near visual acuity | 3 weeks post operatively | 
| Self-reported visual disturbances | Self-reported visual disturbances | 3 weeks post operatively | 
| Quality of Vision After Surgery (QUVID) questionnaire | Patient self-reported satisfaction and quality of vision | 3 weeks post operatively | 
| Intraocular Lens Satisfaction (IOLSAT) questionnaire | Patient self-reported satisfaction and quality of vision | 3 weeks post operatively | 
| Post-op refraction | Post-op refraction | 3 weeks post operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vivity, Pseudophakia