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

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.

Study Overview

• Status: Completed
• Conditions: Pseudophakia
• Intervention / Treatment: Diagnostic test: Defocus Curve; Diagnostic test: Visual Acuity; Other: Intraocular Lens Satisfaction (IOLSAT) Questionnaire; Other: Quality of Vision After Surgery (QUVID) Questionnaire; Other: Visual Disturbance Questionnaire; Diagnostic test: Topography and Tomography

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77027
      • Berkeley Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with healthy eyes, prior myopic LASIK or PRK with SA greater than 0.3, and uncomplicated bilateral implantation of the Vivity IOL (DAT***/CCWET*).

Description

Inclusion Criteria:

1. 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*)
2. 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
3. Able to comprehend and willing to sign informed consent and complete all required testing procedures
4. Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.10 logMAR (Minimum Angle of Resolution) or better
5. Clear intraocular media
6. Minimum of two weeks post YAG (yttrium aluminum garnet) capsulotomy to treat PCO (posterior capsular opacification)
7. Residual refractive astigmatism ≤0.50 diopters
8. Post-operative refractive spherical equivalent from +0.50 to -0.50 spherical equivalent

Exclusion Criteria:

1. 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
2. Any complication during cataract surgery (capsular tear, vitrectomy, etc)
3. History of or current retinal conditions or predisposition to retinal conditions or predisposition to retinal conditions
4. Amblyopia or strabismus in either eye
5. History of or current anterior or posterior segment inflammation of any etiology
6. Any form of neovascularization on or within the eye
7. Glaucoma (uncontrolled or controlled with medication)
8. Optic nerve atrophy
9. Subjects with diagnosed degenerative eye disorders
10. Postoperative CDVA worse than 0.10 logMAR in either eye.
11. 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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Vivity IOL Group; Patients with bilateral implantation of Vivity IOLs.

Diagnostic test: Defocus Curve; Measurement of a defocus curve; Diagnostic test: Visual Acuity; Monocular and binocular measurement of distance, intermediate, and near visual acuity; Other: Intraocular Lens Satisfaction (IOLSAT) Questionnaire; Self-reported post-operative patient satisfaction with vision after surgery; Other: Quality of Vision After Surgery (QUVID) Questionnaire; Self-reported post-operative patient vision quality after surgery; Other: Visual Disturbance Questionnaire; Questionnaire of self-reported visual disturbances of patients; Diagnostic test: Topography and Tomography; Topography and tomography measurements with Atlas, iTrace, and/or Pentacam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular Best Corrected Distance Visual Acuity	Binocular Best Corrected Distance Visual Acuity in logMAR	3 weeks post operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular Visual Acuity	Monocular UDVA (uncorrected distance visual acuity), UIVA (uncorrected intermediate visual acuity), UNVA (uncorrected near visual acuity), and CDVA (corrected distance visual acuity)	3 weeks post operatively
Binocular Distance, Intermediate, and Near Visual Acuity	Binocular distance (UDVA), intermediate (UIVA, DCIVA), and near visual acuity (UNVA, DCNVA)	3 weeks post operatively
Quality of Vision After Surgery (QUVID) Questionnaire	Patient reported disphotopsias by QUVID questionnaire will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. The percentage of subjects that answered "Never" or "Rarely" for frequency are provided.	3 weeks post operatively
Intraocular Lens Satisfaction (IOLSAT) Questionnaire	Patient reported satisfaction by IOLSAT questionnaire will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. The percentage of patients "Satisfied" or "Very Satisfied" will be added for a total satisfaction percentage.	3 weeks post operatively
Post-op Refraction	Manifest refraction spherical equivalent (MRSE)	3 weeks post operatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular Defocus Curve	Binocular defocus curve (distance corrected)	3 weeks post operatively
Spectacle Independence (IOLSAT)	Spectacle independence utilizing the IOLSAT will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. Spectacle independence was defined as answering "Never" or "Rarely" on the IOLSAT, the data presented is the percentage of subjects answering "Never" or "Rarely".	3 weeks post operatively

Collaborators and Investigators

• Sponsor: Berkeley Eye Center
• Investigators: Principal Investigator: Morgan Micheletti, MD, Berkeley Eye Center

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2023
• Primary Completion (Actual): December 11, 2024
• Study Completion (Actual): December 11, 2024

Study Registration Dates

• First Submitted: September 12, 2023
• First Submitted That Met QC Criteria: September 26, 2023
• First Posted (Actual): October 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Vivity; Pseudophakia
• Additional Relevant MeSH Terms: Pseudophakia
• Other Study ID Numbers: 69865263

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes