Trial Outcomes & Findings for Clinical Investigation of the Next-Generation Intraocular Lens (NCT NCT03111550)

NCT ID: NCT03111550

Last Updated: 2025-06-24

Results Overview

The primary effectiveness endpoint is mean (LogMAR), photopic, monocular, first-eye, distance corrected near visual acuity (40 cm) at 1 month postoperative

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 242 participants
• Primary outcome timeframe: 1 month postoperative
• Results posted on: 2025-06-24

Participant Flow

A total of 242 subjects were enrolled in this study, and 229 subjects were implanted with study IOL in first eye.

Participant milestones

Measure	Tecnis ZHR00 Investigational Lens Device	Tecnis ZQR00 Investigational Lens Device	Tecnis ZXR00 Control Lens Device
Overall Study STARTED	77	73	79
Overall Study COMPLETED	73	71	76
Overall Study NOT COMPLETED	4	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Investigation of the Next-Generation Intraocular Lens

Baseline characteristics by cohort

Measure	Tecnis ZHR00 n=77 Participants Investigational Lens Device	Tecnis ZQR00 n=73 Participants Investigational Lens Device	Tecnis ZXR00 n=79 Participants Control Lens Device	Total n=229 Participants Total of all reporting groups
Age, Customized Les than < 60 years	10 Participants n=5 Participants	11 Participants n=7 Participants	7 Participants n=5 Participants	28 Participants n=4 Participants
Age, Customized 60-69 years	37 Participants n=5 Participants	34 Participants n=7 Participants	44 Participants n=5 Participants	115 Participants n=4 Participants
Age, Customized 70-79 years	29 Participants n=5 Participants	24 Participants n=7 Participants	27 Participants n=5 Participants	80 Participants n=4 Participants
Age, Customized Greater than or equal to >= 80 years	1 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Age, Customized Not reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	47 Participants n=7 Participants	46 Participants n=5 Participants	141 Participants n=4 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	26 Participants n=7 Participants	33 Participants n=5 Participants	88 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	76 Participants n=5 Participants	71 Participants n=7 Participants	77 Participants n=5 Participants	224 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Asian (including Indian)	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian/Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	71 Participants n=5 Participants	69 Participants n=7 Participants	73 Participants n=5 Participants	213 Participants n=4 Participants
Race/Ethnicity, Customized Other race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 1 month postoperative

Population: The safety population (SP) of all subjects implanted who have available data will be used for all analysis. For the monocular endpoints, the safety population will consist of first eyes implanted with a study IOL.

The primary effectiveness endpoint is mean (LogMAR), photopic, monocular, first-eye, distance corrected near visual acuity (40 cm) at 1 month postoperative

Outcome measures

Measure	Tecnis ZHR00 n=76 Participants Investigational Lens Device	Tecnis ZQR00 n=72 Participants Investigational Lens Device	Tecnis ZXR00 n=78 Eyes Control Lens Device
Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm	0.136 LogMAR Standard Deviation 0.120	0.141 LogMAR Standard Deviation 0.149	0.276 LogMAR Standard Deviation 0.116

PRIMARY outcome

Timeframe: 6 months postoperative

Population: Statistical comparisons to ISO SPE rates are based on first-eye data

Adverse Event rates for the Models ZHR00 and ZQR00 investigational lens first eyes are compared to the ISO (International Organization for Standardization) SPE (Safety and performance Endpoint) rates using a one-sided, exact test based on the binomial distribution.

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies).

ISO 11979-7 is a document that specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.

SPE rate: safety and performance endpoint (rate derived from analysis of the data from clinical investigations of IOLs approved in the US).

Only AE rates that are higher than ISO SPE rate value are required to do statistical comparison. Any AE rate that is below ISO SPE value, statistical testing is not necessary to see if the rate is significantly higher than ISO.

Outcome measures

Measure	Tecnis ZHR00 n=73 Participants Investigational Lens Device	Tecnis ZQR00 n=71 Participants Investigational Lens Device	Tecnis ZXR00 n=76 Participants Control Lens Device
Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) Corneal edema	0.0 Percent	0.0 Percent	1.3 Percent
Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) Cystoid macular edema	0.0 Percent	0.0 Percent	0.0 Percent
Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) Iritis	0.0 Percent	0.0 Percent	0.0 Percent
Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) Raised IOP requiring treatment	0.0 Percent	0.0 Percent	0.0 Percent

PRIMARY outcome

Timeframe: 6 months postoperative

Population: Statistical comparisons to ISO SPE rates are based on first-eye data

Adverse Event rates for the Models ZHR00 and ZQR00 investigational lens first eyes are compared to the ISO SPE rates using a one-sided, exact test based on the binomial distribution.

Only AE rates that are higher than ISO SPE rate value are required to do statistical comparison. Any AE rate that is below ISO SPE value, statistical testing is not necessary to see if the rate is significantly higher than ISO.

Outcome measures

Measure	Tecnis ZHR00 n=77 Participants Investigational Lens Device	Tecnis ZQR00 n=73 Participants Investigational Lens Device	Tecnis ZXR00 n=79 Participants Control Lens Device
Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) Lens dislocated from posterior chamber	0.0 Percent	0.0 Percent	0.0 Percent
Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) Pupillary block	0.0 Percent	0.0 Percent	0.0 Percent
Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) Cystoid Macular Edema	0.0 Percent	0.0 Percent	1.3 Percent
Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) Hypopyon	0.0 Percent	0.0 Percent	0.0 Percent
Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) Endolphthalmitis	0.0 Percent	0.0 Percent	0.0 Percent
Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) Retinal detachment	0.0 Percent	1.4 Percent	0.0 Percent
Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) Eyes with secondary surgical intervention	1.3 Percent	4.1 Percent	1.3 Percent

Adverse Events

Tecnis ZHR00

Serious events: 8 serious events

Other events: 4 other events

Deaths: 2 deaths

ZQR00

Serious events: 7 serious events

Other events: 3 other events

Deaths: 0 deaths

ZXR00

Serious events: 5 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Measure	Tecnis ZHR00 n=78 participants at risk Investigational Lens Device	ZQR00 n=73 participants at risk Investigational Lens Device	ZXR00 n=79 participants at risk Control Lens Device
Eye disorders Retinal tear and repair	0.00% 0/78 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	1.4% 1/73 • Number of events 1 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	0.00% 0/79 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.
Vascular disorders Blood Clot in leg requiring emergency angioplasty	0.00% 0/78 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	0.00% 0/73 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	1.3% 1/79 • Number of events 1 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.
Product Issues Secondary Surgical Intervention: IOL removal	1.3% 1/78 • Number of events 1 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	1.4% 1/73 • Number of events 2 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	1.3% 1/79 • Number of events 2 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.
Eye disorders Cystoid Macular Edema	0.00% 0/78 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	0.00% 0/73 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	1.3% 1/79 • Number of events 2 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer	0.00% 0/78 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	1.4% 1/73 • Number of events 1 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	0.00% 0/79 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/78 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	1.4% 1/73 • Number of events 1 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	0.00% 0/79 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.
Surgical and medical procedures Hernia Surgical repair	1.3% 1/78 • Number of events 1 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	0.00% 0/73 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	0.00% 0/79 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.
Eye disorders Retinal Detachment	0.00% 0/78 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	1.4% 1/73 • Number of events 1 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	0.00% 0/79 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.
Gastrointestinal disorders Diverticulitis of Large intestine with perforation resulting in hospitalization	1.3% 1/78 • Number of events 1 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	0.00% 0/73 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	0.00% 0/79 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.
Eye disorders Lens removal due to undesired optical phenomena due to fixed pupil	0.00% 0/78 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	1.4% 1/73 • Number of events 1 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	0.00% 0/79 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.
Cardiac disorders Heart Attack	1.3% 1/78 • Number of events 1 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	0.00% 0/73 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	0.00% 0/79 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.
General disorders Death during sleep	1.3% 1/78 • Number of events 1 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	0.00% 0/73 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	0.00% 0/79 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hospitalization due to surgical removal of tumors	1.3% 1/78 • Number of events 1 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	0.00% 0/73 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	0.00% 0/79 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death secondary to cancer	1.3% 1/78 • Number of events 1 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	0.00% 0/73 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	1.3% 1/79 • Number of events 1 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hospitalization due to weakness secondary to cancer	0.00% 0/78 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	0.00% 0/73 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	1.3% 1/79 • Number of events 1 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.
Injury, poisoning and procedural complications Hospitalization due to hip fracture secondary to fall	1.3% 1/78 • Number of events 1 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	0.00% 0/73 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	0.00% 0/79 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.
Surgical and medical procedures Hospitalization due to cholecystectomy	0.00% 0/78 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	1.4% 1/73 • Number of events 1 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	0.00% 0/79 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.

Other adverse events

Measure	Tecnis ZHR00 n=78 participants at risk Investigational Lens Device	ZQR00 n=73 participants at risk Investigational Lens Device	ZXR00 n=79 participants at risk Control Lens Device
Product Issues ADE, Bothersome visual symptoms causing significant impairment lasting more than 3 mos postop	5.1% 4/78 • Number of events 4 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	4.1% 3/73 • Number of events 3 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.	3.8% 3/79 • Number of events 3 • 6 months The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.

Additional Information

Devi Priya Janakiraman,OD, FAAO

Johnson & Johnson Surgical Vision

Phone: +1 714-247-8628

Email: djanaki1@its.jnj.com

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