Trial Outcomes & Findings for Visual Outcomes of Vivity in Patients With High Axial Length (NCT NCT05210569)

Results Overview

Binocular uncorrected distance visual acuity (logMAR)

Recruitment status

COMPLETED

Target enrollment

20 participants

Primary outcome timeframe

3 months postoperatively

Results posted on

2025-03-11

Participant Flow

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	Bilateral Implantation of the Vivity IOL Vivity intraocular lens (IOL) Vivity: Vivity intraocular lens (IOL)
Overall Study STARTED	20 40
Overall Study COMPLETED	20 40
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Visual Outcomes of Vivity in Patients With High Axial Length

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bilateral Implantation of the Vivity IOL n=40 Eyes Vivity intraocular lens (IOL) Vivity: Vivity intraocular lens (IOL)
Age, Continuous	65.7 years STANDARD_DEVIATION 6.5 • n=20 Participants
Sex: Female, Male Female	8 Participants n=20 Participants
Sex: Female, Male Male	12 Participants n=20 Participants

PRIMARY outcome

Timeframe: 3 months postoperatively

Binocular uncorrected distance visual acuity (logMAR)

Outcome measures

Outcome measures
Measure	Bilateral Implantation of the Vivity IOL n=20 Participants Vivity intraocular lens (IOL) Vivity: Vivity intraocular lens (IOL)
Binocular Uncorrected Distance Visual Acuity (logMAR)	-0.1 logMAR Standard Deviation 0.06

PRIMARY outcome

Timeframe: 3 months postoperatively

Binocular uncorrected intermediate visual acuity (logMAR)

Outcome measures

Outcome measures
Measure	Bilateral Implantation of the Vivity IOL n=20 Participants Vivity intraocular lens (IOL) Vivity: Vivity intraocular lens (IOL)
Binocular Uncorrected Intermediate Visual Acuity (logMAR)	0.01 logMAR Standard Deviation 0.08

PRIMARY outcome

Timeframe: 3 months postoperatively

Binocular uncorrected near visual acuity (logMAR)

Outcome measures

Outcome measures
Measure	Bilateral Implantation of the Vivity IOL n=20 Participants Vivity intraocular lens (IOL) Vivity: Vivity intraocular lens (IOL)
Binocular Uncorrected Near Visual Acuity (logMAR)	0.21 logMAR Standard Deviation 0.11

SECONDARY outcome

Timeframe: 3 months postoperatively

Percentage of eyes with absolute prediction error of 0.5D or less

Outcome measures

Outcome measures
Measure	Bilateral Implantation of the Vivity IOL n=40 Eyes Vivity intraocular lens (IOL) Vivity: Vivity intraocular lens (IOL)
Prediction Error	35 Eyes

SECONDARY outcome

Timeframe: 3 months postoperatively

Binocular corrected distance visual acuity (logMAR)

Outcome measures

Outcome measures
Measure	Bilateral Implantation of the Vivity IOL n=20 Participants Vivity intraocular lens (IOL) Vivity: Vivity intraocular lens (IOL)
Binocular Corrected Distance Visual Acuity (logMAR)	-0.14 logMAR Standard Deviation 0.06

SECONDARY outcome

Timeframe: 3 months postoperatively

Binocular distance corrected intermediate visual acuity (logMAR)

Outcome measures

Outcome measures
Measure	Bilateral Implantation of the Vivity IOL n=20 Participants Vivity intraocular lens (IOL) Vivity: Vivity intraocular lens (IOL)
Binocular Distance Corrected Intermediate Visual Acuity (logMAR)	-0.02 logMAR Standard Deviation 0.06

SECONDARY outcome

Timeframe: 3 months postoperatively

Binocular distance corrected near visual acuity (logMAR)

Outcome measures

Outcome measures
Measure	Bilateral Implantation of the Vivity IOL n=20 Participants Vivity intraocular lens (IOL) Vivity: Vivity intraocular lens (IOL)
Binocular Distance Corrected Near Visual Acuity (logMAR)	0.18 logMAR Standard Deviation 0.1

SECONDARY outcome

Timeframe: 3 months postoperatively

Monocular corrected distance visual acuity (logMAR)

Outcome measures

Outcome measures
Measure	Bilateral Implantation of the Vivity IOL n=40 Eyes Vivity intraocular lens (IOL) Vivity: Vivity intraocular lens (IOL)
Monocular Corrected Distance Visual Acuity (logMAR)	-0.09 logMAR Standard Deviation 0.05

SECONDARY outcome

Timeframe: 3 months postoperatively

Monocular distance corrected intermediate visual acuity (logMAR)

Outcome measures

Outcome measures
Measure	Bilateral Implantation of the Vivity IOL n=40 Eyes Vivity intraocular lens (IOL) Vivity: Vivity intraocular lens (IOL)
Monocular Distance Corrected Intermediate Visual Acuity (logMAR)	0.05 logMAR Standard Deviation 0.09

SECONDARY outcome

Timeframe: 3 months postoperatively

Monocular distance corrected near visual acuity (logMAR)

Outcome measures

Outcome measures
Measure	Bilateral Implantation of the Vivity IOL n=40 Eyes Vivity intraocular lens (IOL) Vivity: Vivity intraocular lens (IOL)
Monocular Distance Corrected Near Visual Acuity (logMAR)	0.32 logMAR Standard Deviation 0.15

SECONDARY outcome

Timeframe: 3 months postoperatively

Manifest refraction spherical equivalent

Outcome measures

Outcome measures
Measure	Bilateral Implantation of the Vivity IOL n=40 Eyes Vivity intraocular lens (IOL) Vivity: Vivity intraocular lens (IOL)
Manifest Refraction Spherical Equivalent	0.25 diopter (D) Standard Deviation 0.37

SECONDARY outcome

Timeframe: 3 months postoperatively

Questionnaire for visual disturbance scores (QUVID)

Outcome measures

Outcome measures
Measure	Bilateral Implantation of the Vivity IOL n=20 Participants Vivity intraocular lens (IOL) Vivity: Vivity intraocular lens (IOL)
Questionnaire "Bothered quite a bit" or "Bothered very much" by halos	0 Participants
Questionnaire "Bothered quite a bit" or "Bothered very much" by starbursts	2 Participants
Questionnaire "Bothered quite a bit" or "Bothered very much" by glare	2 Participants
Questionnaire "Bothered quite a bit" or "Bothered very much" by haze	1 Participants
Questionnaire "Bothered quite a bit" or "Bothered very much" by blurred vision	0 Participants
Questionnaire "Bothered quite a bit" or "Bothered very much" by double vision	0 Participants
Questionnaire "Bothered quite a bit" or "Bothered very much" by dark area	0 Participants

SECONDARY outcome

Timeframe: 3 months

The Intraocular Lens Satisfaction questionnaire (IOLSAT). Subjects were asked how often they needed to wear eyeglasses to see at distance, intermediate, and near. The percentage was calculated as (# of subjects responding "Never" or "Rarely") divided by (# of subjects) times 100. A higher percentage is a better outcome.

Outcome measures

Outcome measures
Measure	Bilateral Implantation of the Vivity IOL n=20 Participants Vivity intraocular lens (IOL) Vivity: Vivity intraocular lens (IOL)
Percentage of Participants With Spectacle Independence Spectacle independence distance (overall)	19 Participants
Percentage of Participants With Spectacle Independence Spectcle independence intermediate (overall)	18 Participants
Percentage of Participants With Spectacle Independence Spectacle independence near (overall)	8 Participants

SECONDARY outcome

Timeframe: 3 months postoperatively

Binocular distance-corrected low contrast distance visual acuity (logMAR)

Outcome measures

Outcome measures
Measure	Bilateral Implantation of the Vivity IOL n=20 Participants Vivity intraocular lens (IOL) Vivity: Vivity intraocular lens (IOL)
Binocular Distance-corrected Low Contrast Distance Visual Acuity (logMAR)	0.05 logMAR Standard Deviation 0.08

Adverse Events

Bilateral Implantation of the Vivity IOL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr James Wiens

Image Plus Laser Eye Centre

Phone: 1-204-943-6287

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place