Trial Outcomes & Findings for Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens (NCT NCT03949335)

Last Updated: 2021-08-27

Results Overview

mean photopic monocular Distance Corrected Near Visual Acuity results at 40 cm for ZFR00 and control first eyes in the safety population at 6 months

Recruitment status

COMPLETED

Study phase

Target enrollment

272 participants

Primary outcome timeframe

6 months (postoperative)

Results posted on

2021-08-27

Participant Flow

272 subjects were bilaterally implanted with either the study or control lens. 135 subjects were bilaterally implanted with the study lens and 137 subjects were bilaterally implanted with the control lens. All 272 subjects were bilaterally implanted with the same IOL model in both eyes.

Participant milestones

Participant milestones
Measure	ZFR00V Study Lens	ZCB00 Control Lens
Overall Study STARTED	135	137
Overall Study COMPLETED	132	131
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ZFR00V n=135 Participants Study Lens	ZCB00 n=137 Participants Control Lens	Total n=272 Participants Total of all reporting groups
Age, Customized <60	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Age, Customized 60 to 69	50 Participants n=5 Participants	57 Participants n=7 Participants	107 Participants n=5 Participants
Age, Customized 70 to 79	62 Participants n=5 Participants	56 Participants n=7 Participants	118 Participants n=5 Participants
Age, Customized > or = 80	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Female	94 Participants n=5 Participants	90 Participants n=7 Participants	184 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	47 Participants n=7 Participants	88 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	127 Participants n=5 Participants	130 Participants n=7 Participants	257 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian (including Indian)	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Black	15 Participants n=5 Participants	19 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian/Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	114 Participants n=5 Participants	116 Participants n=7 Participants	230 Participants n=5 Participants
Race/Ethnicity, Customized Other Race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months (postoperative)

Population: The safety (SP) population for monocular Distance-Corrected Near Visual Acuity include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)

mean photopic monocular Distance Corrected Near Visual Acuity results at 40 cm for ZFR00 and control first eyes in the safety population at 6 months

Outcome measures

Outcome measures
Measure	ZFR00V n=131 Eyes Study Lens	ZCB00 n=130 Eyes Control Lens
Distance-Corrected Near Visual Acuity (DCNVA) at 40 cm	0.104 LogMAR Standard Deviation 0.138	0.522 LogMAR Standard Deviation 0.193

SECONDARY outcome

Timeframe: 6 months (postoperative)

Population: The safety (SP) population for monocular Distance-Corrected Intermediate Visual Acuity include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)

mean photopic monocular Distance-Corrected Intermediate Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population

Outcome measures

Outcome measures
Measure	ZFR00V n=131 Eyes Study Lens	ZCB00 n=130 Eyes Control Lens
Monocular Distance-Corrected Intermediate Visual Acuity at 66 cm	0.060 LogMAR Standard Deviation 0.115	0.335 LogMAR Standard Deviation 0.155

SECONDARY outcome

Timeframe: 6 months postoperative

mean photopic monocular Distance-Corrected Near Visual Acuity results at 33 cm for ZFR00 and control first eyes in the safety population at 6 months

Outcome measures

Outcome measures
Measure	ZFR00V n=131 Eyes Study Lens	ZCB00 n=130 Eyes Control Lens
Monocular Distance-Corrected Near Visual Acuity at 33 cm	0.154 LogMAR Standard Deviation 0.151	0.608 LogMAR Standard Deviation 0.187

SECONDARY outcome

Timeframe: 6 months postoperative

Population: The safety (SP) population for monocular Best-Corrected Distance Visual Acuity include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)

mean monocular Best-Corrected Distance Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population.

Outcome measures

Outcome measures
Measure	ZFR00V n=131 Eyes Study Lens	ZCB00 n=130 Eyes Control Lens
Monocular Photopic Best-Corrected Distance Visual Acuity	-0.014 LogMAR Standard Deviation 0.087	-0.045 LogMAR Standard Deviation 0.089

SECONDARY outcome

Timeframe: 6 months postoperative

Population: The safety (SP) population for monocular Distance-Corrected Defocus Curve include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)

Mean monocular (first eye) distance-corrected defocus curve for each lens group at 6 months in the safety population

Outcome measures

Outcome measures
Measure	ZFR00V n=131 Eyes Study Lens	ZCB00 n=130 Eyes Control Lens
Monocular Distance-Corrected Defocus Curve	-3.3 diopter Interval -3.6 to -3.0	-0.9 diopter Interval -1.1 to -0.7

SECONDARY outcome

Timeframe: 6 months postoperative

Population: The safety (SP) population for spectacle independence include all subjects implanted bilaterally with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)

Spectacle wear is determined via the PRO questionnaire instrument and defined as wearing glasses or contacts "none of the time" in all 4 conditions (distance vision, intermediate vision, near vision and overall vision) at 6 months postoperative.

Outcome measures

Outcome measures
Measure	ZFR00V n=131 Participants Study Lens	ZCB00 n=131 Participants Control Lens
Spectacle Wear None of the time	115 Participants	4 Participants
Spectacle Wear A little/Some/Most/All of the time	16 Participants	127 Participants
Spectacle Wear Not reported	0 Participants	0 Participants

Adverse Events

ZFR00V First Eye

Serious events: 6 serious events

Other events: 10 other events

Deaths: 0 deaths

ZCB00 First Eye

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

ZFR00V Second Eye

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

ZCB00 Second Eye

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ZFR00V First Eye n=135 participants at risk Study Lens	ZCB00 First Eye n=137 participants at risk Control Lens	ZFR00V Second Eye n=135 participants at risk Study Lens	ZCB00 Second Eye n=137 participants at risk Control Lens
Eye disorders Cystoid Macular Edema	0.74% 1/135 • Number of events 1 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.73% 1/137 • Number of events 1 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.74% 1/135 • Number of events 1 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/137 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.
Product Issues Undesirable Optical Phenomena	0.74% 1/135 • Number of events 1 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/137 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/135 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/137 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.
Eye disorders Retinal Detachment/tear	0.00% 0/135 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/137 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/135 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.73% 1/137 • Number of events 1 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.
Eye disorders Macular Hole	0.00% 0/135 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/137 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.74% 1/135 • Number of events 1 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/137 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.
Eye disorders Herpes Simplex Virus Keratitis	0.00% 0/135 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/137 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/135 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.73% 1/137 • Number of events 1 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.
Product Issues Toxic Anterior Segment Syndrome	0.00% 0/135 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/137 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.74% 1/135 • Number of events 1 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/137 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.
Eye disorders Corneal Ulcers	0.00% 0/135 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/137 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/135 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.73% 1/137 • Number of events 1 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.
Product Issues Hypopyon	0.00% 0/135 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/137 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.74% 1/135 • Number of events 1 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/137 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.
Surgical and medical procedures Retained lens material resulting in secondary surgical intervention	0.00% 0/135 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/137 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.74% 1/135 • Number of events 1 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/137 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.
General disorders Hospitalization	0.74% 1/135 • Number of events 1 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/137 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.74% 1/135 • Number of events 1 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/137 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.
Musculoskeletal and connective tissue disorders Fractured right fibula and dislocated ankle requiring surgery	0.74% 1/135 • Number of events 1 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/137 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.74% 1/135 • Number of events 1 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/137 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.
Cardiac disorders Hospitalization	0.00% 0/135 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.73% 1/137 • Number of events 1 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/135 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.73% 1/137 • Number of events 1 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.
General disorders Abdominal Hernia requiring surgical repair	0.74% 1/135 • Number of events 1 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/137 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.74% 1/135 • Number of events 1 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/137 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.
Infections and infestations Hospitalization	0.74% 1/135 • Number of events 1 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/137 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.74% 1/135 • Number of events 1 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/137 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.

Other adverse events

Other adverse events
Measure	ZFR00V First Eye n=135 participants at risk Study Lens	ZCB00 First Eye n=137 participants at risk Control Lens	ZFR00V Second Eye n=135 participants at risk Study Lens	ZCB00 Second Eye n=137 participants at risk Control Lens
Product Issues Undesirable Optical Phenomena	7.4% 10/135 • Number of events 10 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/137 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/135 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.	0.00% 0/137 • 6 months Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.

Additional Information

Eugenia Thomas, OD

Johnson & Johnson Surgical Vision

Phone: +1 657 2903260

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor must review results communication prior to public release and can embargo communications regarding trial results at anytime.
Publication restrictions are in place

Restriction type: OTHER