Trial Outcomes & Findings for Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00 (NCT NCT02529488)

NCT ID: NCT02529488

Last Updated: 2018-07-02

Results Overview

Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best spectacle correction at a distance of 4 meters. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The 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 visual acuity. The defocus VA summaries are based on the number of subjects evaluable for Best-Case Analysis Set and have data available at the corresponding visit. No formal statistical hypothesis testing was planned.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 167 participants
• Primary outcome timeframe: Day 20-40 and Day 120-180 from second eye implantation
• Results posted on: 2018-07-02

Participant Flow

Subjects were recruited from 17 study centers located in Australia (4), Chile (3), Germany (2), Italy (2), Spain (2), Belgium (1), Great Britain (1), France (1), and Netherlands (1).

Of the 167 enrolled, 16 subjects were exited as screen failures prior to being implanted. An additional 2 subjects satisfied the eligibility criteria for the study, but were also discontinued prior to being implanted. This reporting group includes all implanted subjects (149).

Participant milestones

Measure	TFNT00 AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
Overall Study STARTED	149
Overall Study COMPLETED	145
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	TFNT00 AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
Overall Study Adverse Event	1
Overall Study Death	3

Baseline Characteristics

Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00

Baseline characteristics by cohort

Measure	TFNT00 n=149 Participants AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
Age, Continuous	68.9 years STANDARD_DEVIATION 9.28 • n=5 Participants
Sex: Female, Male Female	92 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	100 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 20-40 and Day 120-180 from second eye implantation

Population: This analysis population includes all eyes successfully implanted with the test article that had at least 1 postoperative visit, no previous surgery for correction of refractive errors, no preoperative ocular pathology or macular degeneration at any time, no pregnancy during the study, and no major protocol deviations (Best-Case Analysis Set).

Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best spectacle correction at a distance of 4 meters. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The 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 visual acuity. The defocus VA summaries are based on the number of subjects evaluable for Best-Case Analysis Set and have data available at the corresponding visit. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	TFNT00 Visit 3A n=137 Participants AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation at Day 20-40 post second eye implantation	TFNT00 Visit 4A n=134 Participants AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation at Day 120-180 post second eye implantation
Mean Binocular Defocus Visual Acuity (VA) +2.00 Diopter (D)	0.570 logMAR Standard Deviation 0.1893	0.569 logMAR Standard Deviation 0.1844
Mean Binocular Defocus Visual Acuity (VA) +1.50D	0.404 logMAR Standard Deviation 0.1610	0.388 logMAR Standard Deviation 0.1679
Mean Binocular Defocus Visual Acuity (VA) +1.00D	0.209 logMAR Standard Deviation 0.1386	0.214 logMAR Standard Deviation 0.1413
Mean Binocular Defocus Visual Acuity (VA) +0.50D	0.069 logMAR Standard Deviation 0.1438	0.058 logMAR Standard Deviation 0.1205
Mean Binocular Defocus Visual Acuity (VA) 0.00D	-0.030 logMAR Standard Deviation 0.1155	-0.037 logMAR Standard Deviation 0.1069
Mean Binocular Defocus Visual Acuity (VA) -0.50D	0.037 logMAR Standard Deviation 0.1099	0.043 logMAR Standard Deviation 0.1180
Mean Binocular Defocus Visual Acuity (VA) -1.00D	0.101 logMAR Standard Deviation 0.1141	0.100 logMAR Standard Deviation 0.1099
Mean Binocular Defocus Visual Acuity (VA) -1.50D	0.072 logMAR Standard Deviation 0.1175	0.065 logMAR Standard Deviation 0.1302
Mean Binocular Defocus Visual Acuity (VA) -2.00D	0.052 logMAR Standard Deviation 0.1270	0.044 logMAR Standard Deviation 0.1316
Mean Binocular Defocus Visual Acuity (VA) -2.50D	0.077 logMAR Standard Deviation 0.1396	0.066 logMAR Standard Deviation 0.1338
Mean Binocular Defocus Visual Acuity (VA) -3.00D	0.148 logMAR Standard Deviation 0.1417	0.130 logMAR Standard Deviation 0.1377
Mean Binocular Defocus Visual Acuity (VA) -3.50D	0.257 logMAR Standard Deviation 0.1532	0.256 logMAR Standard Deviation 0.1551
Mean Binocular Defocus Visual Acuity (VA) -4.00D	0.387 logMAR Standard Deviation 0.1624	0.384 logMAR Standard Deviation 0.1530
Mean Binocular Defocus Visual Acuity (VA) -4.50D	0.495 logMAR Standard Deviation 0.1674	0.491 logMAR Standard Deviation 0.1583
Mean Binocular Defocus Visual Acuity (VA) -5.00D	0.621 logMAR Standard Deviation 0.1597	0.617 logMAR Standard Deviation 0.1548

Adverse Events

TFNT00 - 1st Eye

Serious events: 3 serious events

Other events: 21 other events

Deaths: 0 deaths

TFNT00 - 2nd Eye

Serious events: 4 serious events

Other events: 21 other events

Deaths: 0 deaths

TFNT00 - Non-Study Eye

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TFNT00 - Systemic

Serious events: 11 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Measure	TFNT00 - 1st Eye n=149 participants at risk All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the 1st implanted eye	TFNT00 - 2nd Eye n=148 participants at risk All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the 2nd implanted eye	TFNT00 - Non-Study Eye n=1 participants at risk All eyes not implanted with a study lens	TFNT00 - Systemic n=149 participants at risk All subjects with attempted test article implantation (successful or aborted after contact with the eye).
Cardiac disorders Acute myocardial infarction	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.67% 1/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Cardiac disorders Atrial fibrillation	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.67% 1/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Cardiac disorders Myocardial infarction	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.67% 1/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Eye disorders Retinal detachment	1.3% 2/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	1.4% 2/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Eye disorders Vision blurred	0.67% 1/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.67% 1/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
General disorders Device dislocation	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.68% 1/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
General disorders Multi-organ failure	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.67% 1/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Infections and infestations Cellulitis	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.67% 1/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Infections and infestations Urinary tract infection	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.67% 1/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.67% 1/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.67% 1/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Investigations Intraocular pressure increased	0.67% 1/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Investigations Optic nerve cup/disc ratio increased	0.67% 1/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.68% 1/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.67% 1/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.67% 1/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Nervous system disorders Cerebrovascular accident	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.67% 1/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Nervous system disorders Visual field defect	0.67% 1/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.68% 1/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Surgical and medical procedures Eye operation	0.67% 1/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Surgical and medical procedures Intraocular lens extraction	0.67% 1/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Surgical and medical procedures Intraocular lens repositioning	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.68% 1/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Surgical and medical procedures Joint arthroplasty	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.67% 1/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Surgical and medical procedures Retinopexy	1.3% 2/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.68% 1/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Surgical and medical procedures Vitrectomy	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.68% 1/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.

Other adverse events

Measure	TFNT00 - 1st Eye n=149 participants at risk All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the 1st implanted eye	TFNT00 - 2nd Eye n=148 participants at risk All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the 2nd implanted eye	TFNT00 - Non-Study Eye n=1 participants at risk All eyes not implanted with a study lens	TFNT00 - Systemic n=149 participants at risk All subjects with attempted test article implantation (successful or aborted after contact with the eye).
Eye disorders Dry eye	10.1% 15/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	8.8% 13/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Eye disorders Posterior capsule opacification	4.0% 6/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	5.4% 8/148 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/1 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/149 • Test article implantation through study completion, an average of 1 year. Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.

Additional Information

Sr. Global Brand Medical Affairs Lead, CDMA Surgical

Alcon, A Novartis Division

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