Trial Outcomes & Findings for Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Intraocular Lens (IOL) in a Korean Population (NCT NCT03268746)

NCT ID: NCT03268746

Last Updated: 2019-09-25

Results Overview

The defocus curve (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best distance correction across full range varied from +2.0 diopter (D) to -5.0 D in 0.5 D increments. The visual acuity (VA) at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better VA. No formal statistical hypothesis testing was planned.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 52 participants
• Primary outcome timeframe: Month 3 (Day 90-120 post second eye implantation)
• Results posted on: 2019-09-25

Participant Flow

Subjects were recruited from 4 study centers located in Korea.

Of the 52 enrolled, 7 subjects exited as screen failures prior to implantation. This reporting group includes all implanted subjects (45).

Participant milestones

Measure	TFNT00 AcrySof IQ PanOptix Multifocal intraocular lens (IOL) Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted
Overall Study STARTED	45
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	TFNT00 AcrySof IQ PanOptix Multifocal intraocular lens (IOL) Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Intraocular Lens (IOL) in a Korean Population

Baseline characteristics by cohort

Measure	TFNT00 n=45 Participants AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted
Age, Continuous	59.7 years STANDARD_DEVIATION 7.95 • n=113 Participants
Sex: Female, Male Female	34 Participants n=113 Participants
Sex: Female, Male Male	11 Participants n=113 Participants
Race/Ethnicity, Customized Race · Asian	45 Participants n=113 Participants
Race/Ethnicity, Customized Race · Others	0 Participants n=113 Participants
Race/Ethnicity, Customized Ethnicity · Korean	45 Participants n=113 Participants
Race/Ethnicity, Customized Ethnicity · Others	0 Participants n=113 Participants

PRIMARY outcome

Timeframe: Month 3 (Day 90-120 post second eye implantation)

Population: This analysis population included all subjects with successful bilateral IOL implantation (Full Analysis Set). Number analyzed is the number of subjects with data available for analysis at specified defocus.

The defocus curve (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best distance correction across full range varied from +2.0 diopter (D) to -5.0 D in 0.5 D increments. The visual acuity (VA) at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better VA. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	TFNT00 n=44 Participants AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted	TFNT00 Second Eye AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the second eye
Binocular Defocus Curve at Month 3 +2.0 D	0.539 logMAR Standard Deviation 0.1188	—
Binocular Defocus Curve at Month 3 +1.5 D	0.364 logMAR Standard Deviation 0.1241	—
Binocular Defocus Curve at Month 3 +1.0 D	0.213 logMAR Standard Deviation 0.1339	—
Binocular Defocus Curve at Month 3 +0.5 D	0.054 logMAR Standard Deviation 0.0977	—
Binocular Defocus Curve at Month 3 0.0 D	-0.049 logMAR Standard Deviation 0.0697	—
Binocular Defocus Curve at Month 3 -0.5 D	0.030 logMAR Standard Deviation 0.0701	—
Binocular Defocus Curve at Month 3 -1.0 D	0.092 logMAR Standard Deviation 0.0854	—
Binocular Defocus Curve at Month 3 -1.5 D	0.060 logMAR Standard Deviation 0.0917	—
Binocular Defocus Curve at Month 3 -2.0 D	0.027 logMAR Standard Deviation 0.0648	—
Binocular Defocus Curve at Month 3 -2.5 D	0.058 logMAR Standard Deviation 0.0800	—
Binocular Defocus Curve at Month 3 -3.0 D	0.134 logMAR Standard Deviation 0.0850	—
Binocular Defocus Curve at Month 3 -3.5 D	0.238 logMAR Standard Deviation 0.0987	—
Binocular Defocus Curve at Month 3 -4.0 D	0.377 logMAR Standard Deviation 0.1178	—
Binocular Defocus Curve at Month 3 -4.5 D	0.510 logMAR Standard Deviation 0.1367	—
Binocular Defocus Curve at Month 3 -5.0 D	0.604 logMAR Standard Deviation 0.1222	—

SECONDARY outcome

Timeframe: Month 1 (Day 30-60 post second eye implantation)

Population: Full Analysis Set. Number analyzed is the number of subjects with data available for analysis at specified defocus.

The defocus curve (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best distance correction across full range varied from +2.0 diopter (D) to -5.0 D in 0.5 D increments. VA at each spherical power was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better VA. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	TFNT00 n=44 Participants AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted	TFNT00 Second Eye AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the second eye
Binocular Defocus Curve at Month 1 +2.0 D	0.581 logMAR Standard Deviation 0.1689	—
Binocular Defocus Curve at Month 1 +1.5 D	0.427 logMAR Standard Deviation 0.1568	—
Binocular Defocus Curve at Month 1 +1.0 D	0.275 logMAR Standard Deviation 0.1325	—
Binocular Defocus Curve at Month 1 +0.5 D	0.111 logMAR Standard Deviation 0.1420	—
Binocular Defocus Curve at Month 1 0.0 D	-0.015 logMAR Standard Deviation 0.0815	—
Binocular Defocus Curve at Month 1 -0.5 D	0.049 logMAR Standard Deviation 0.0785	—
Binocular Defocus Curve at Month 1 -1.0 D	0.086 logMAR Standard Deviation 0.0678	—
Binocular Defocus Curve at Month 1 -1.5 D	0.093 logMAR Standard Deviation 0.0800	—
Binocular Defocus Curve at Month 1 -2.0 D	0.080 logMAR Standard Deviation 0.1046	—
Binocular Defocus Curve at Month 1 -2.5 D	0.090 logMAR Standard Deviation 0.1229	—
Binocular Defocus Curve at Month 1 -3.0 D	0.167 logMAR Standard Deviation 0.1253	—
Binocular Defocus Curve at Month 1 -3.5 D	0.264 logMAR Standard Deviation 0.1455	—
Binocular Defocus Curve at Month 1 -4.0 D	0.360 logMAR Standard Deviation 0.1385	—
Binocular Defocus Curve at Month 1 -4.5 D	0.505 logMAR Standard Deviation 0.1585	—
Binocular Defocus Curve at Month 1 -5.0 D	0.640 logMAR Standard Deviation 0.1358	—

SECONDARY outcome

Timeframe: Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)

Population: Full Analysis Set. Number analyzed is the number of subjects with data available for analysis at specified time point.

VA was tested binocularly under photopic conditions using the correction obtained from the manual manifest refraction and 100% contrast, ETDRS charts at a distance of 4 meters from the spectacle plane. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	TFNT00 n=44 Participants AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted	TFNT00 Second Eye AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the second eye
Binocular Best Corrected Distance Visual Acuity (BCDVA) [4 Meters (m)] Month 1	-0.015 logMAR Standard Deviation 0.0815	—
Binocular Best Corrected Distance Visual Acuity (BCDVA) [4 Meters (m)] Month 3	-0.049 logMAR Standard Deviation 0.0697	—

SECONDARY outcome

Timeframe: Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)

Population: This analysis population included all subjects with successful implantation of the test product in at least one eye (All-implanted Analysis Set). Number analyzed is the number of subjects/eyes with data available for analysis at specified time point.

VA was tested monocularly (each eye separately) under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 4 m from the eye, corresponding to a far distance for visual tasks. UCDVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. Both eyes contributed to the analysis. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	TFNT00 n=45 Participants AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted	TFNT00 Second Eye n=44 Eyes AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the second eye
Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 m) Month 1	0.089 logMAR Standard Deviation 0.1203	0.097 logMAR Standard Deviation 0.1078
Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 m) Month 3	0.073 logMAR Standard Deviation 0.1002	0.081 logMAR Standard Deviation 0.1328

SECONDARY outcome

Timeframe: Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)

Population: All-implanted Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at specified time point.

VA was tested monocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 60 cm from the eye, representative of intermediate distances for visual tasks. UCIVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. Both eyes contributed to the analysis. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	TFNT00 n=45 Eyes AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted	TFNT00 Second Eye n=44 Eyes AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the second eye
Monocular Uncorrected Intermediate Visual Acuity (UCIVA) [60 Centimeters (cm)] Month 1	0.080 logMAR Standard Deviation 0.1493	0.080 logMAR Standard Deviation 0.1407
Monocular Uncorrected Intermediate Visual Acuity (UCIVA) [60 Centimeters (cm)] Month 3	0.054 logMAR Standard Deviation 0.1217	0.035 logMAR Standard Deviation 0.1295

SECONDARY outcome

Timeframe: Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)

Population: All-implanted Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at specified time point.

VA was tested monocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 40 cm from the eye, representative of near distances for visual tasks. UCNVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. Both eyes contributed to the analysis. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	TFNT00 n=45 Eyes AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted	TFNT00 Second Eye n=44 Eyes AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the second eye
Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) Month 1	0.116 logMAR Standard Deviation 0.1284	0.104 logMAR Standard Deviation 0.1219
Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) Month 3	0.089 logMAR Standard Deviation 0.1334	0.091 logMAR Standard Deviation 0.1226

SECONDARY outcome

Timeframe: Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)

Population: Full Analysis Set. Number analyzed is the number of subjects with data available for analysis at specified time point.

VA was tested binocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 4 m from the eye, corresponding to a far distance for visual tasks. UCDVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	TFNT00 n=44 Participants AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted	TFNT00 Second Eye AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the second eye
Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 m) Month 1	0.049 logMAR Standard Deviation 0.1071	—
Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 m) Month 3	0.026 logMAR Standard Deviation 0.0987	—

SECONDARY outcome

Timeframe: Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)

Population: Full Analysis Set

VA was tested binocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 60 cm from the eye, representative of intermediate distances for visual tasks. UCIVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	TFNT00 n=44 Participants AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted	TFNT00 Second Eye AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the second eye
Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) Month 1	0.015 logMAR Standard Deviation 0.1242	—
Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) Month 3	-0.025 logMAR Standard Deviation 0.1113	—

SECONDARY outcome

Timeframe: Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)

Population: Full Analysis Set

VA was tested binocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 40 cm from the eye, representative of near distances for visual tasks. UCNVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	TFNT00 n=44 Participants AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted	TFNT00 Second Eye AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the second eye
Binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) Month 1	0.047 logMAR Standard Deviation 0.1221	—
Binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) Month 3	0.029 logMAR Standard Deviation 0.1222	—

SECONDARY outcome

Timeframe: Month 3 (Day 90-120 post second eye implantation)

Population: Full Analysis Set

Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed binocularly under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT with a glare source. A higher numeric value will represent better contrast sensitivity. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	TFNT00 n=44 Participants AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted	TFNT00 Second Eye AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the second eye
Binocular Photopic Best Corrected Contrast Sensitivity With Glare 12 cpd	1.539 log unit Standard Deviation 0.2113	—
Binocular Photopic Best Corrected Contrast Sensitivity With Glare 3 cpd	1.673 log unit Standard Deviation 0.1316	—
Binocular Photopic Best Corrected Contrast Sensitivity With Glare 6 cpd	1.907 log unit Standard Deviation 0.1691	—
Binocular Photopic Best Corrected Contrast Sensitivity With Glare 18 cpd	1.139 log unit Standard Deviation 0.2038	—

SECONDARY outcome

Timeframe: Month 3 (Day 90-120 post second eye implantation)

Population: Full Analysis Set

Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed binocularly under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, 12, and 18 cpd using the Vector Vision CSV 1000-HGT without a glare source. A higher numeric value will represent better contrast sensitivity. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	TFNT00 n=44 Participants AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted	TFNT00 Second Eye AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the second eye
Binocular Photopic Best Corrected Contrast Sensitivity Without Glare 3 cpd	1.676 log unit Standard Deviation 0.1647	—
Binocular Photopic Best Corrected Contrast Sensitivity Without Glare 6 cpd	1.878 log unit Standard Deviation 0.1747	—
Binocular Photopic Best Corrected Contrast Sensitivity Without Glare 12 cpd	1.588 log unit Standard Deviation 0.2317	—
Binocular Photopic Best Corrected Contrast Sensitivity Without Glare 18 cpd	1.133 log unit Standard Deviation 0.2268	—

SECONDARY outcome

Timeframe: Preoperative and Month 3 (Day 90-120 post second eye implantation)

Population: Full Analysis Set (FAS)

Subjects responded to 12 SSQs based on their experience during past 7 days for quality of vision and any change since cataract surgery as follows; Q1:How satisfied are you with your vision for seeing objects at near distance(ND)? Q2:How often do you wear eyeglasses or contact lenses for seeing objects at ND? Q3:How satisfied are you with your vision for seeing objects at intermediate distance(ID)? Q4:How often do you wear eyeglasses or contact lens for seeing objects at ID? Q5:How satisfied are you with your vision for seeing objects at distance(D)? Q6:How often do you wear eyeglasses or contact lens for seeing objects at D? Q7:How often do you experience halos? Q8:How severe were these halos? Q9:If you CURRENTLY DRIVE: how much difficulty do you have driving at night? Q10:If you DO NOT DRIVE at night, what is the reason? Q11:How satisfied are you with your cataract surgery result? Q12:Would you recommend cataract surgery and new lenses that were put into your eyes to other people?

Outcome measures

Measure	TFNT00 n=44 Participants AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted	TFNT00 Second Eye n=44 Participants AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the second eye
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q8: Severe	15.9 percentage of subjects	31.8 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q9: No difficulty at all	11.4 percentage of subjects	9.1 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q9: A little difficulty	11.4 percentage of subjects	11.4 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q9: Moderate difficulty	29.5 percentage of subjects	25.0 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q9: Extreme difficulty	25.0 percentage of subjects	22.7 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q9: NA : I do not drive at night	22.7 percentage of subjects	31.8 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q10: Because of your current eyesight	27.3 percentage of subjects	25.0 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q10: Because you are not interested in driving	11.4 percentage of subjects	11.4 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q10: Because you have other reasons	22.7 percentage of subjects	27.3 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q10: NA: I drive at night	38.6 percentage of subjects	36.4 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q11: Very dissatisfied	NA percentage of subjects Q11 was not applicable for subjects in Preoperative arm.	4.5 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q11: Dissatisfied	NA percentage of subjects Q11 was not applicable for subjects in Preoperative arm.	2.3 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q11: Neither satisfied nor dissatisfied	NA percentage of subjects Q11 was not applicable for subjects in Preoperative arm.	18.2 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q11: Satisfied	NA percentage of subjects Q11 was not applicable for subjects in Preoperative arm.	54.5 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q11: Very satisfied	NA percentage of subjects Q11 was not applicable for subjects in Preoperative arm.	20.5 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q12: No	NA percentage of subjects Q12 was not applicable for subjects in Preoperative arm.	36.4 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q12: Yes	NA percentage of subjects Q12 was not applicable for subjects in Preoperative arm.	63.6 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q1: Very dissatisfied	47.7 percentage of subjects	2.3 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q1: Dissatisfied	40.9 percentage of subjects	4.5 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q1: Neither satisfied nor dissatisfied	6.8 percentage of subjects	9.1 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q1: Satisfied	4.5 percentage of subjects	63.6 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q1: Very satisfied	0.0 percentage of subjects	20.5 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q2: None of the time	15.9 percentage of subjects	84.1 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q2: Some of the time	15.9 percentage of subjects	13.6 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q2: Most of the time	25.0 percentage of subjects	0.0 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q2: All of the time	43.2 percentage of subjects	2.3 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q3: Very dissatisfied	25.0 percentage of subjects	2.3 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q3: Dissatisfied	61.4 percentage of subjects	9.1 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q3: Neither satisfied nor dissatisfied	6.8 percentage of subjects	11.4 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q3: Satisfied	6.8 percentage of subjects	56.8 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q3: Very satisfied	0.0 percentage of subjects	20.5 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q4: None of the time	20.5 percentage of subjects	90.9 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q4: Some of the time	27.3 percentage of subjects	6.8 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q4: Most of the time	25.0 percentage of subjects	0.0 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q4: All of the time	27.3 percentage of subjects	2.3 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q5: Very dissatisfied	20.5 percentage of subjects	2.3 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q5: Dissatisfied	43.2 percentage of subjects	6.8 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q5: Neither satisfied nor dissatisfied	25.0 percentage of subjects	20.5 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q5: Satisfied	11.4 percentage of subjects	59.1 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q5: Very satisfied	0.0 percentage of subjects	11.4 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q6: None of the time	31.8 percentage of subjects	95.5 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q6: Some of the time	20.5 percentage of subjects	2.3 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q6: Most of the time	11.4 percentage of subjects	0.0 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q6: All of the time	36.4 percentage of subjects	2.3 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q7: None of the time	22.7 percentage of subjects	6.8 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q7: Some of the time	45.5 percentage of subjects	25.0 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q7: Most of the time	22.7 percentage of subjects	34.1 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q7: All of the time	9.1 percentage of subjects	34.1 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q8: None	20.5 percentage of subjects	6.8 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q8: Mild	29.5 percentage of subjects	11.4 percentage of subjects
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) Q8: Moderate	34.1 percentage of subjects	50.0 percentage of subjects

Adverse Events

Preoperative

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

TFNT00 First Eye

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

TFNT00 Second Eye

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

TFNT00 Systemic

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Preoperative n=45 participants at risk All subjects in the safety analysis set prior to initiation of treatment	TFNT00 First Eye n=45 participants at risk AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the first eye	TFNT00 Second Eye n=44 participants at risk AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the second eye	TFNT00 Systemic n=45 participants at risk All subjects with attempted test article implantation (successful or aborted after contact with the eye)
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.00% 0/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/44 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	2.2% 1/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Product Issues Device dislocation	0.00% 0/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	2.3% 1/44 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/44 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	2.2% 1/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Surgical and medical procedures Surgery	0.00% 0/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	2.3% 1/44 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.

Other adverse events

Measure	Preoperative n=45 participants at risk All subjects in the safety analysis set prior to initiation of treatment	TFNT00 First Eye n=45 participants at risk AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the first eye	TFNT00 Second Eye n=44 participants at risk AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the second eye	TFNT00 Systemic n=45 participants at risk All subjects with attempted test article implantation (successful or aborted after contact with the eye)
Eye disorders Dry eye	0.00% 0/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	24.4% 11/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	22.7% 10/44 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Eye disorders Glare	0.00% 0/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	22.2% 10/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	20.5% 9/44 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Eye disorders Visual impairment	2.2% 1/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	6.7% 3/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	6.8% 3/44 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Eye disorders Halo vision	0.00% 0/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	6.7% 3/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	6.8% 3/44 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Eye disorders Foreign body sensation in eyes	0.00% 0/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	6.7% 3/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	4.5% 2/44 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Eye disorders Vitreous floaters	0.00% 0/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	4.4% 2/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	6.8% 3/44 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/44 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	6.7% 3/45 • Pre-operation through study completion, an average of 7 months Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.

Additional Information

Clinical/Brand Lead

Alcon Research

Phone: 1-888-451-3937

Email: alcon.medinfo@alcon.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
• Publication restrictions are in place

Restriction type: OTHER