Trial Outcomes & Findings for Evaluation of Clareon Vivity/Vivity Toric (NCT NCT05852470)

Last Updated: 2024-11-05

Results Overview

Visual acuity (VA) was assessed with best refractive correction in place under photopic (well-lit) conditions at a distance of 4 meters (m) using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together. This is a co-primary endpoint.

Recruitment status

COMPLETED

Study phase

Target enrollment

155 participants

Primary outcome timeframe

Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)

Results posted on

2024-11-05

Participant Flow

Participants were enrolled at 7 investigative sites located in the United States.

Of the 155 enrolled, 5 participants were exited as screen failures. This reporting group includes all eligible subjects (150).

Participant milestones

Participant milestones
Measure	Clareon Vivity/Vivity Toric Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation	Clareon Monofocal/Clareon Toric Previous implantation in both eyes with Clareon Monofocal/Clareon Toric IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation
Overall Study STARTED	73	77
Overall Study Full Analysis Set	73	76
Overall Study COMPLETED	73	76
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Clareon Vivity/Vivity Toric Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation	Clareon Monofocal/Clareon Toric Previous implantation in both eyes with Clareon Monofocal/Clareon Toric IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Evaluation of Clareon Vivity/Vivity Toric

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clareon Vivity/Vivity Toric n=73 Participants Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation	Clareon Monofocal/Clareon Toric n=76 Participants Previous implantation in both eyes with Clareon Monofocal/Clareon Toric IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation	Total n=149 Participants Total of all reporting groups
Age, Continuous	68.4 years STANDARD_DEVIATION 8.92 • n=5 Participants	71.5 years STANDARD_DEVIATION 6.97 • n=7 Participants	70.0 years STANDARD_DEVIATION 8.10 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	46 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	30 Participants n=7 Participants	61 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	73 Participants n=5 Participants	75 Participants n=7 Participants	148 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	68 Participants n=5 Participants	63 Participants n=7 Participants	131 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	73 participants n=5 Participants	76 participants n=7 Participants	149 participants n=5 Participants

PRIMARY outcome

Timeframe: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)

Population: FAS. Note: One subject in the Clareon Monofocal/Clareon Toric arm discontinued after Visit 0; thus, the data from this subject at this visit is not included.

Outcome measures

Outcome measures
Measure	Clareon Vivity/Vivity Toric n=73 Participants Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation	Clareon Monofocal/Clareon Toric n=75 Participants Previous implantation in both eyes with Clareon Monofocal/Clareon Toric IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation
Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant	-0.028 logMAR Standard Deviation 0.1165	-0.062 logMAR Standard Deviation 0.0847

PRIMARY outcome

Timeframe: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)

Population: FAS. Note: One subject in the Clareon Monofocal/Clareon Toric arm discontinued after Visit 0; thus, the data from this subject at this visit is not included.

Visual acuity (VA) was assessed with distance correction in place (plus or minus power) under photopic (well-lit) conditions at a distance of 66 centimeters (cm) from the spectacle plane using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together. This is a co-primary endpoint.

Outcome measures

Outcome measures
Measure	Clareon Vivity/Vivity Toric n=73 Participants Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation	Clareon Monofocal/Clareon Toric n=75 Participants Previous implantation in both eyes with Clareon Monofocal/Clareon Toric IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation
Mean Binocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant	0.035 logMAR Standard Deviation 0.0788	0.126 logMAR Standard Deviation 0.1033

SECONDARY outcome

Timeframe: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)

Population: FAS. Note: One subject in the Clareon Monofocal/Clareon Toric arm discontinued after Visit 0; thus, the data from this subject at this visit is not included.

Visual acuity (VA) was assessed with distance correction in place (plus or minus power) under photopic (well-lit) conditions at a distance of 40 centimeters (cm) from the spectacle plane using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together.

Outcome measures

Outcome measures
Measure	Clareon Vivity/Vivity Toric n=73 Participants Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation	Clareon Monofocal/Clareon Toric n=75 Participants Previous implantation in both eyes with Clareon Monofocal/Clareon Toric IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation
Mean Binocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant	0.205 logMAR Standard Deviation 0.1008	0.334 logMAR Standard Deviation 0.1410

SECONDARY outcome

Timeframe: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)

Population: FAS with requisite data at visit. Note: One subject in the Clareon Monofocal/Clareon Toric arm discontinued after Visit 0; thus, the data from this subject at this visit is not included.

The IOLSAT is a patient-reported outcomes questionnaire. Subjects were asked, "Overall, in the past 7 days, how often did you need to wear eyeglasses to see?" The percentage was calculated as (# of subjects responding "Never") divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100. A higher percentage is a better outcome.