Trial Outcomes & Findings for Clinical Investigation of the Next-Generation Intraocular Lenses (NCT NCT03372434)

Last Updated: 2025-06-24

Results Overview

Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified for the first operative eye only.

Recruitment status

COMPLETED

Study phase

Target enrollment

225 participants

Primary outcome timeframe

1 month

Results posted on

2025-06-24

Participant Flow

225 subjects were implanted with a study lens in at least one eye. Two hundred and twenty five (225) subjects had a study IOL in the first eye.

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	Model ZFR00 Investigational IOL implanted in the first eye	Model ZLB00 Control IOL implanted in the first eye	Model ZYR00 Investigational IOL implanted in the first eye
Overall Study STARTED	78 78	73 73	74 74
Overall Study 1 Month Follow-up	76 76	72 72	73 73
Overall Study COMPLETED	76 76	70 70	72 72
Overall Study NOT COMPLETED	2 2	3 3	2 2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Investigation of the Next-Generation Intraocular Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Model ZFR00 n=78 Participants Investigational IOL implanted in the first eye	Model ZLB00 n=73 Participants Control IOL implanted in the first eye	Model ZYR00 n=74 Participants Investigational IOL implanted in the first eye	Total n=225 Participants Total of all reporting groups
Age, Customized Less than <60 years	10 Participants n=5 Participants	13 Participants n=7 Participants	17 Participants n=5 Participants	40 Participants n=4 Participants
Age, Customized 60-69 years	38 Participants n=5 Participants	35 Participants n=7 Participants	34 Participants n=5 Participants	107 Participants n=4 Participants
Age, Customized 70-79 years	27 Participants n=5 Participants	23 Participants n=7 Participants	21 Participants n=5 Participants	71 Participants n=4 Participants
Age, Customized Greater than or equal to >/80 years	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	7 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	54 Participants n=5 Participants	48 Participants n=7 Participants	49 Participants n=5 Participants	151 Participants n=4 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	25 Participants n=7 Participants	25 Participants n=5 Participants	74 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	74 Participants n=5 Participants	67 Participants n=7 Participants	71 Participants n=5 Participants	212 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)	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Black	3 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	17 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	75 Participants n=5 Participants	62 Participants n=7 Participants	66 Participants n=5 Participants	203 Participants n=4 Participants
Race/Ethnicity, Customized Another Race	0 Participants n=5 Participants	1 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	1 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: 1 month

Population: Safety population

Outcome measures

Outcome measures
Measure	Model ZFR00 n=76 Eyes Investigational IOL implanted in the first eye	Model ZLB00 n=72 Eyes Control IOL implanted in the first eye	Model ZYR00 n=73 Eyes Investigational IOL implanted in the first eye
Distance Corrected Intermediate Visual Acuity	0.098 LogMAR Standard Deviation 0.115	0.219 LogMAR Standard Deviation 0.146	0.147 LogMAR Standard Deviation 0.149

Adverse Events

Model ZFR00

Serious events: 5 serious events

Other events: 6 other events

Deaths: 0 deaths

Model ZLB00

Serious events: 13 serious events

Other events: 1 other events

Deaths: 0 deaths

Model ZYR00

Serious events: 4 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Model ZFR00 n=78 participants at risk Investigational IOL device	Model ZLB00 n=73 participants at risk Control IOL Device	Model ZYR00 n=74 participants at risk Investigational IOL Device
Product Issues Bothersome visual symptom	7.7% 6/78 • Number of events 6 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	1.4% 1/73 • Number of events 1 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	4.1% 3/74 • Number of events 3 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.

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

Measure	Model ZFR00 n=78 participants at risk Investigational IOL device	Model ZLB00 n=73 participants at risk Control IOL Device	Model ZYR00 n=74 participants at risk Investigational IOL Device
Eye disorders Cystoid Macular Edema	0.00% 0/78 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	0.00% 0/73 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	2.7% 2/74 • Number of events 2 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.
Eye disorders Macular Hole	0.00% 0/78 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	1.4% 1/73 • Number of events 1 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	0.00% 0/74 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.
Product Issues Bothersome Visual Symptom	1.3% 1/78 • Number of events 1 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	1.4% 1/73 • Number of events 1 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	1.4% 1/74 • Number of events 1 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.
Eye disorders Herpes Zoster Keratitis	0.00% 0/78 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	1.4% 1/73 • Number of events 1 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	0.00% 0/74 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.
Eye disorders Retinal Detachment	1.3% 1/78 • Number of events 1 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	0.00% 0/73 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	0.00% 0/74 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.
Product Issues Visual symptoms requiring secondary surgical intervention	1.3% 1/78 • Number of events 1 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	0.00% 0/73 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	1.4% 1/74 • Number of events 1 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.
Eye disorders Haptic anterior to capsule bag	0.00% 0/78 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	1.4% 1/73 • Number of events 1 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	0.00% 0/74 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.
Eye disorders Increase in cells likely due to non-compliance with ocular medication regimen	1.3% 1/78 • Number of events 1 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	0.00% 0/73 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	0.00% 0/74 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.
Eye disorders Retinal Hole	0.00% 0/78 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	1.4% 1/73 • Number of events 1 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	0.00% 0/74 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	1.3% 1/78 • Number of events 1 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	1.4% 1/73 • Number of events 1 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	0.00% 0/74 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.
General disorders Hospitalization	0.00% 0/78 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	4.1% 3/73 • Number of events 3 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	1.4% 1/74 • Number of events 1 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.
Cardiac disorders Patent Foramen Ovale	0.00% 0/78 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	1.4% 1/73 • Number of events 1 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	0.00% 0/74 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.
Cardiac disorders Angioplasty	0.00% 0/78 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	1.4% 1/73 • Number of events 1 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	0.00% 0/74 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.
Blood and lymphatic system disorders B-cell Lymphoma	0.00% 0/78 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	1.4% 1/73 • Number of events 1 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	0.00% 0/74 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.
Infections and infestations Shingles	0.00% 0/78 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	1.4% 1/73 • Number of events 1 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	0.00% 0/74 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.
General disorders Undisclosed illness requiring Hospice care	0.00% 0/78 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	1.4% 1/73 • Number of events 1 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.	0.00% 0/74 • 6 months All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.