Trial Outcomes & Findings for Evaluation of Vision After Vivity IOL Implantation With a Target of Slight Myopia in the Non-dominant Eye (NCT NCT04482439)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

3 months postop

Results posted on

2022-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	Vivity Monovision Group Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Overall Study STARTED	35
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Vivity Monovision Group Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Overall Study Lost to Follow-up	1
Overall Study Unrelated illness	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vivity Monovision Group n=33 Participants Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Age, Continuous	70 years STANDARD_DEVIATION 5.5 • n=33 Participants
Sex: Female, Male Female	21 Participants n=33 Participants
Sex: Female, Male Male	12 Participants n=33 Participants
Region of Enrollment United States	33 participants n=33 Participants

PRIMARY outcome

Timeframe: 3 months postop

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

Outcome measures

Outcome measures
Measure	Vivity Monovision Group n=33 Participants Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Binocular Near Visual Acuity	0.14 logMAR Standard Deviation 0.10

SECONDARY outcome

Timeframe: 3 months postop

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

Outcome measures

Outcome measures
Measure	Vivity Monovision Group n=66 Eyes Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Prediction Accuracy	56 Eyes

SECONDARY outcome

Timeframe: 3 months postop

Population: All subjects who completed 3M PRSIQ questionnaire successfully

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")

Outcome measures

Outcome measures
Measure	Vivity Monovision Group n=32 Participants Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Spectacle Independence	26 Participants

SECONDARY outcome

Timeframe: 3 months postop

Patients reporting rarely or never needing glasses overall

Outcome measures

Outcome measures
Measure	Vivity Monovision Group n=33 Participants Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Patient Spectacle Independence	23 Participants

SECONDARY outcome

Timeframe: 3 months postop

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

Outcome measures

Outcome measures
Measure	Vivity Monovision Group n=33 Participants Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Number of Participants Rating Frequency of Visual Disturbances as "Never" or "Rarely" Glare frequency "never" or 'rarely"	19 Participants
Number of Participants Rating Frequency of Visual Disturbances as "Never" or "Rarely" Halos frequency "never" or "rarely"	18 Participants
Number of Participants Rating Frequency of Visual Disturbances as "Never" or "Rarely" Starbursts frequency "never" or "rarely"	13 Participants

SECONDARY outcome

Timeframe: 3 months postop

Population: Each subject had 1 eye targeted for plano, and one eye targeted for myopia. So, each row includes 33 eyes of 33 subjects.

Manifest refraction (residual spherical equivalent refraction)

Outcome measures

Outcome measures
Measure	Vivity Monovision Group n=66 Eyes Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Manifest Refraction Eyes targeted for plano	.01 diopters Standard Deviation .31
Manifest Refraction Eyes targeted for myopia	-.74 diopters Standard Deviation 0.39

SECONDARY outcome

Timeframe: 3 months

Residual refractive cylinder after surgery

Outcome measures

Outcome measures
Measure	Vivity Monovision Group n=66 Eyes Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Residual Cylinder	0.42 diopters Standard Deviation 0.30

SECONDARY outcome

Timeframe: 3 months postop

Bilateral uncorrected distance visual acuity

Outcome measures

Outcome measures
Measure	Vivity Monovision Group n=33 Participants Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Uncorrected Distance Visual Acuity	0.02 logMAR Standard Deviation 0.09

SECONDARY outcome

Timeframe: 3 months postop

Bilateral uncorrected visual acuity at 66 cm

Outcome measures

Outcome measures
Measure	Vivity Monovision Group n=33 Participants Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Uncorrected Intermediate Visual Acuity	0 logMAR Standard Deviation .07

SECONDARY outcome

Timeframe: 3 months postop

Bilateral uncorrected near visual acuity at 40 cm

Outcome measures

Outcome measures
Measure	Vivity Monovision Group n=33 Participants Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Uncorrected Near Visual Acuity	0.12 logMAR Standard Deviation 0.1

SECONDARY outcome

Timeframe: 3 months postop

Bliateral corrected distance visual acuity

Outcome measures

Outcome measures
Measure	Vivity Monovision Group n=33 Participants Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Corrected Distance Visual Acuity	0.01 logMAR Standard Deviation 0.08

SECONDARY outcome

Timeframe: 3 months postop

Bliateral distance corrected visual acuity at 66 cm

Outcome measures

Outcome measures
Measure	Vivity Monovision Group n=33 Participants Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Distance Corrected Intermediate Visual Acuity	0.02 logMAR Standard Deviation 0.06

Adverse Events

Vivity Monovision Group

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

T. Hunter Newsom, MD

Newsom Eye and Laser Center

Phone: 813-908-2020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place