NCT06064916

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

Completed Results posted Last updated 23 May 2025

What this trial tests

trial testing Visual Acuity in Pseudophakia in 20 participants. Completed in 11 December 2024.

Timeline

25 July 2023

Primary endpoint
11 December 2024

11 December 2024

Quick facts

Lead sponsor	Berkeley Eye Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	20
Start date	25 July 2023
Primary completion	11 December 2024
Estimated completion	11 December 2024
Sites	1 location across United States

Drugs / interventions tested

• Visual Acuity
• Defocus Curve
• Intraocular Lens Satisfaction (IOLSAT) Questionnaire
• Quality of Vision After Surgery (QUVID) Questionnaire
• Visual Disturbance Questionnaire
• Topography and Tomography

Conditions studied

• Pseudophakia — all drugs for Pseudophakia →

Sponsor

Berkeley Eye Center — full company profile →

Who can join

40 and older, any sex, with Pseudophakia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Binocular Best Corrected Distance Visual Acuity Primary · 3 weeks post operatively

Binocular Best Corrected Distance Visual Acuity in logMAR

Group	Value	95% CI
Vivity IOL Group	-0.05	± 0.09

Monocular Visual Acuity Secondary · 3 weeks post operatively

Monocular UDVA (uncorrected distance visual acuity), UIVA (uncorrected intermediate visual acuity), UNVA (uncorrected near visual acuity), and CDVA (corrected distance visual acuity)

UDVA

Group	Value	95% CI
Vivity IOL Group	0.06	± 0.11

UIVA

Group	Value	95% CI
Vivity IOL Group	0.18	± 0.12

UNVA

Group	Value	95% CI
Vivity IOL Group	0.31	± 0.19

CDVA

Group	Value	95% CI
Vivity IOL Group	0.00	± 0.08

Binocular Distance, Intermediate, and Near Visual Acuity Secondary · 3 weeks post operatively

Binocular distance (UDVA), intermediate (UIVA, DCIVA), and near visual acuity (UNVA, DCNVA)

UDVA

Group	Value	95% CI
Vivity IOL Group	0.02	± 0.16

UIVA

Group	Value	95% CI
Vivity IOL Group	0.14	± 0.13

DCIVA

Group	Value	95% CI
Vivity IOL Group	0.11	± 0.11

UNVA

Group	Value	95% CI
Vivity IOL Group	0.24	± 0.14

DCNVA

Group	Value	95% CI
Vivity IOL Group	0.25	± 0.15

Quality of Vision After Surgery (QUVID) Questionnaire Secondary · 3 weeks post operatively

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.

Starburst

Group	Value	95% CI
Vivity IOL Group	11

Halos

Group	Value	95% CI
Vivity IOL Group	13

Glare

Group	Value	95% CI
Vivity IOL Group	9

Haze

Group	Value	95% CI
Vivity IOL Group	15

Blurred Vision

Group	Value	95% CI
Vivity IOL Group	15

Double Vision

Group	Value	95% CI
Vivity IOL Group	19

Dark Area

Group	Value	95% CI
Vivity IOL Group	20

Intraocular Lens Satisfaction (IOLSAT) Questionnaire Secondary · 3 weeks post operatively

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.

Group	Value	95% CI
Vivity IOL Group	16

Post-op Refraction Secondary · 3 weeks post operatively

Manifest refraction spherical equivalent (MRSE)

Group	Value	95% CI
Vivity IOL Group	-0.11	± 0.31

Binocular Defocus Curve Secondary · 3 weeks post operatively

Binocular defocus curve (distance corrected)

-3.00 D

Group	Value	95% CI
Vivity IOL Group	0.39	± 0.17

-2.50 D

Group	Value	95% CI
Vivity IOL Group	0.26	± 0.17

-2.00 D

Group	Value	95% CI
Vivity IOL Group	0.17	± 0.13

-1.50 D

Group	Value	95% CI
Vivity IOL Group	0.05	± 0.12

-1.00 D

Group	Value	95% CI
Vivity IOL Group	0.03	± 0.11

-0.50 D

Group	Value	95% CI
Vivity IOL Group	0.00	± 0.11

-0.25 D

Group	Value	95% CI
Vivity IOL Group	-0.05	± 0.09

0.00 D

Group	Value	95% CI
Vivity IOL Group	-0.06	± 0.09

Spectacle Independence (IOLSAT) Secondary · 3 weeks post operatively

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".

Overall

Group	Value	95% CI
Vivity IOL Group	90

Distance

Group	Value	95% CI
Vivity IOL Group	90

Intermediate

Group	Value	95% CI
Vivity IOL Group	75

Near

Group	Value	95% CI
Vivity IOL Group	30

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Satisfaction and Visual Outcomes with a Non-Diffractive EDOF IOL in Post-Myopic LASIK and PRK Patients with High Corneal Spherical Aberration.
   Micheletti JM, Hall B. · · 2026 · PMID 41858986 · DOI 10.2147/opth.s566800