Trial Outcomes & Findings for Vivity IOL: Emmetropia Compared to Monovision. (NCT NCT05464732)
NCT ID: NCT05464732
Last Updated: 2025-03-24
Results Overview
The logMAR binocular uncorrected visual acuity at 40 cm will be measured.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
3 months
Results posted on
2025-03-24
Participant Flow
A total of 33 subjects were enrolled in the study. One was lost to follow up and one experienced a progression of their macular degeneration, leaving 31 subjects for analysis.
Participant milestones
| Measure |
Monovision Then Emmetropia
All study participants received the Vivity IOL in both eyes.
1. Target refraction plano (emmetropia): the target was (0.00 D) for both the dominant and the non-dominant eye. Corrected vision will involve correcting both eyes for plano.
2. Target refraction monovision where the target was (0.00 D) for the dominant eye and between -0.50 D and -0.75 D for the non-dominant eye. Corrected vision will involve correcting the dominant eye for emmetropia and the non-dominant eye for -0.50 D.
|
Emmetropia Then Monovision
All study participants received the Vivity IOL in both eyes.
1. Target refraction plano (emmetropia): the target was (0.00 D) for both the dominant and the non-dominant eye. Corrected vision will involve correcting both eyes for plano.
2. Target refraction monovision where the target was (0.00 D) for the dominant eye and between -0.50 D and -0.75 D for the non-dominant eye. Corrected vision will involve correcting the dominant eye for emmetropia and the non-dominant eye for -0.50 D.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
|
Overall Study
COMPLETED
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Monovision Then Emmetropia
All study participants received the Vivity IOL in both eyes.
1. Target refraction plano (emmetropia): the target was (0.00 D) for both the dominant and the non-dominant eye. Corrected vision will involve correcting both eyes for plano.
2. Target refraction monovision where the target was (0.00 D) for the dominant eye and between -0.50 D and -0.75 D for the non-dominant eye. Corrected vision will involve correcting the dominant eye for emmetropia and the non-dominant eye for -0.50 D.
|
Emmetropia Then Monovision
All study participants received the Vivity IOL in both eyes.
1. Target refraction plano (emmetropia): the target was (0.00 D) for both the dominant and the non-dominant eye. Corrected vision will involve correcting both eyes for plano.
2. Target refraction monovision where the target was (0.00 D) for the dominant eye and between -0.50 D and -0.75 D for the non-dominant eye. Corrected vision will involve correcting the dominant eye for emmetropia and the non-dominant eye for -0.50 D.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Vivity IOL: Emmetropia Compared to Monovision.
Baseline characteristics by cohort
| Measure |
Overall
n=31 Participants
All study participants received the Vivity IOL in both eyes.
The same group of participants were evaluated twice using two different target refractions:
1. Target refraction plano: the target was (0.00 D) for both the dominant and the non-dominant eye. Corrected vision will involve correcting both eyes for plano.
2. Target refraction monovision where the target was (0.00 D) for the dominant eye and between -0.50 D and -0.75 D for the non-dominant eye. Corrected vision will involve correcting the dominant eye for emmetropia and the non-dominant eye for -0.50 D.
Participants were randomized to which target was evaluated first and there was a 10 minutes break between the 2 evaluations.
|
|---|---|
|
Age, Continuous
|
69.5 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsThe logMAR binocular uncorrected visual acuity at 40 cm will be measured.
Outcome measures
| Measure |
Monovision
n=31 Participants
The target refraction is plano (0.00 D) for the dominant eye and between -0.50 D and -0.75 D for the non-dominant eye. The Vivity IOL will be implanted bilaterally.
Corrected vision will involve correcting the dominant eye for emmetropia and the non-dominant eye for -0.50 D.
Vivity IOL: The Vivity IOL will be implanted bilaterally in all subjects.
|
Emmetropia
n=31 Participants
Subject's vision will be tested with both eyes corrected for emmetropia.
Vivity IOL: The Vivity IOL will be implanted bilaterally in all subjects.
|
|---|---|---|
|
Binocular Uncorrected Near (40 cm) Visual Acuity
|
0.21 logMAR
Standard Deviation 0.11
|
0.39 logMAR
Standard Deviation 0.16
|
Adverse Events
Monovision
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Emmetropia
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
Director of Clinical Trials
Carolina Eyecare Physicians, LLC
Phone: 8438813937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place