NCT04482439

Evaluation of Vision After Vivity IOL Implantation With a Target of Slight Myopia in the Non-dominant Eye

Completed NA Results posted Last updated 3 March 2022

What this trial tests

NA trial testing Vivity Extended Depth of Focus intraocular lens (IOL) in Cataract in 35 participants. Completed in 10 June 2021.

Timeline

17 July 2020

Primary endpoint
10 June 2021

10 June 2021

Quick facts

Lead sponsor	Newsom Eye & Laser Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	17 July 2020
Primary completion	10 June 2021
Estimated completion	10 June 2021
Sites	1 location across United States

Drugs / interventions tested

• Vivity Extended Depth of Focus intraocular lens (IOL)

Conditions studied

• Cataract — all drugs for Cataract →

Sponsor

Newsom Eye & Laser Center

Who can join

40 and older, any sex, with Cataract. 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 Near Visual Acuity Primary · 3 months postop

binocular distance-corrected near (40 cm) visual acuity at 3 months postoperative.

Group	Value	95% CI
Vivity Monovision Group	0.14	± 0.10

Prediction Accuracy Secondary · 3 months postop

Percentage of eyes with postoperative refractive accuracy within 0.5D of target

Group	Value	95% CI
Vivity Monovision Group	56

Spectacle Independence Secondary · 3 months postop

Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire - "a little of the time" or "none of the time")

Group	Value	95% CI
Vivity Monovision Group	26

Patient Spectacle Independence Secondary · 3 months postop

Patients reporting rarely or never needing glasses overall

Group	Value	95% CI
Vivity Monovision Group	23

Number of Participants Rating Frequency of Visual Disturbances as "Never" or "Rarely" Secondary · 3 months postop

This is the frequency of subjects responding, "Never" or "Rarely" to a question about the frequency of glare, halos and starbursts.

Glare frequency "never" or 'rarely"

Group	Value	95% CI
Vivity Monovision Group	19

Halos frequency "never" or "rarely"

Group	Value	95% CI
Vivity Monovision Group	18

Starbursts frequency "never" or "rarely"

Group	Value	95% CI
Vivity Monovision Group	13

Manifest Refraction Secondary · 3 months postop

Manifest refraction (residual spherical equivalent refraction)

Eyes targeted for plano

Group	Value	95% CI
Vivity Monovision Group	.01	± .31

Eyes targeted for myopia

Group	Value	95% CI
Vivity Monovision Group	-.74	± 0.39

Residual Cylinder Secondary · 3 months

Residual refractive cylinder after surgery

Group	Value	95% CI
Vivity Mini-monovision	0.42	± 0.30

Uncorrected Distance Visual Acuity Secondary · 3 months postop

Bilateral uncorrected distance visual acuity

Group	Value	95% CI
Vivity Monovision Group	0.02	± 0.09

Uncorrected Intermediate Visual Acuity Secondary · 3 months postop

Bilateral uncorrected visual acuity at 66 cm

Group	Value	95% CI
Vivity Monovision Group	0	± .07

Uncorrected Near Visual Acuity Secondary · 3 months postop

Bilateral uncorrected near visual acuity at 40 cm

Group	Value	95% CI
Vivity Monovision Group	0.12	± 0.1

Corrected Distance Visual Acuity Secondary · 3 months postop

Bliateral corrected distance visual acuity

Group	Value	95% CI
Vivity Monovision Group	0.01	± 0.08

Distance Corrected Intermediate Visual Acuity Secondary · 3 months postop

Bliateral distance corrected visual acuity at 66 cm

Group	Value	95% CI
Vivity Monovision Group	0.02	± 0.06

Sponsor's own description

The objective is to assess binocular distance-corrected near (40 cm) visual acuity of patients after uneventful cataract surgery with bilateral implantation of the AcrySof® Vivity Intraocular lens (IOL) when the non-dominant eye is targeted for slight myopia.

Publications & conference data

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

1. Evaluation of Quality of Vision and Visual Outcomes with Bilateral Implantation of a Non-Diffractive Extended Vision Intraocular Lens with a Target of Slight Myopia in the Non-Dominant Eye.
   Newsom TH, Potvin R. · · 2022 · cited 31× · PMID 35115758 · DOI 10.2147/opth.s350850