Trial Outcomes & Findings for Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens, Model DEN00V (NCT NCT05574959)

Last Updated: 2026-08-11

Results Overview

Monocular photopic distance-corrected intermediate visual acuity (DCIVA) in logMAR at 66 cm for first eyes. Note that a lower logMAR value denotes better visual acuity. The difference in mean visual acuity is calculated as control group minus test group. This analysis was prespecified for the first operative eye.

Recruitment status

TERMINATED

Study phase

Target enrollment

243 participants

Primary outcome timeframe

6 Months

Results posted on

2026-08-11

Participant Flow

Prospective, multicenter, bilateral, interventional, controlled, masked, randomized, clinical investigation of the DEN00V IOL (EDF; test) and the ZCB00/DCB00 IOL (monofocal; control). Enrollment targeted up to 250 participants at up to 10 sites to achieve \~200 bilaterally implanted participants (100 per group) evaluable at 6 months.

Out of 243 enrolled participants a total of 202 participants were randomized in this study.

Participant milestones

Participant milestones
Measure	Investigational Lens Device Investigational IOL Model DEN00V	Control Lens Device Control IOL Model ZCB00/DCB00
Overall Study STARTED	100	102
Overall Study ITT Population	100	102
Overall Study Safety Population	99	99
Overall Study COMPLETED	97	99
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Investigational Lens Device Investigational IOL Model DEN00V	Control Lens Device Control IOL Model ZCB00/DCB00
Overall Study Withdrawal by Subject	3	3

Baseline Characteristics

Baseline measurements are based on the ITT population.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 6 Months

Population: Intent To Treat Population

Outcome measures

Outcome measures
Measure	Investigational Lens Device n=100 Eyes Investigational IOL Model DEN00V	Control Lens Device n=102 Eyes Control IOL Model ZCB00/DCB00
Monocular DCIVA at 66cm for First Eyes	0.169 logMAR Standard Error 0.010	0.313 logMAR Standard Error 0.018

PRIMARY outcome

Timeframe: 6 Months

Population: Intent To Treat Population

Monocular photopic best-corrected distance visual acuity (BCDVA) in logMAR at 4 meters for the first eyes. Note that a lower logMAR value denotes better visual acuity. The difference in mean visual acuity is calculated as control group minus test group. This analysis was prespecified for the first operative eye.

Outcome measures

Outcome measures
Measure	Investigational Lens Device n=100 Eyes Investigational IOL Model DEN00V	Control Lens Device n=102 Eyes Control IOL Model ZCB00/DCB00
Monocular BCDVA at 4 Meters for First Eyes	-0.017 logMAR Standard Error 0.009	-0.048 logMAR Standard Error 0.010

PRIMARY outcome

Timeframe: 6 Months

Population: Intent To Treat Population

Monocular depth of defocus where visual acuity is 0.20 logMAR or better (measured only negative direction from zero diopter) for first eyes. The data values reported represent the diopter of defocus at which the mean visual acuity for all participants crosses the 0.20 logMAR threshold. Therefore, the values reported are represented as a single value for each arm. This analysis was prespecified for the first operative eye.

Outcome measures

Outcome measures
Measure	Investigational Lens Device n=100 Eyes Investigational IOL Model DEN00V	Control Lens Device n=102 Eyes Control IOL Model ZCB00/DCB00
Monocular Depth of Focus for First Eyes	-1.328 Diopter	-1.007 Diopter

Adverse Events

Investigational Lens Device

Serious events: 9 serious events

Other events: 0 other events

Deaths: 1 deaths

Control Lens Device

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Investigational Lens Device n=99 participants at risk Investigational IOL Model DEN00V	Control Lens Device n=99 participants at risk Control IOL Model ZCB00/DCB00
Eye disorders Increased IOP	1.0% 1/99 • 6 Months Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. Safety analysis set included all participants for whom a study IOL touched the eye.	2.0% 2/99 • 6 Months Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. Safety analysis set included all participants for whom a study IOL touched the eye.
Cardiac disorders Cardiac Arrest	1.0% 1/99 • 6 Months Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. Safety analysis set included all participants for whom a study IOL touched the eye.	0.00% 0/99 • 6 Months Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. Safety analysis set included all participants for whom a study IOL touched the eye.
Reproductive system and breast disorders Hysterectomy	1.0% 1/99 • 6 Months Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. Safety analysis set included all participants for whom a study IOL touched the eye.	1.0% 1/99 • 6 Months Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. Safety analysis set included all participants for whom a study IOL touched the eye.
Eye disorders Lens Exchange	3.0% 3/99 • 6 Months Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. Safety analysis set included all participants for whom a study IOL touched the eye.	0.00% 0/99 • 6 Months Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. Safety analysis set included all participants for whom a study IOL touched the eye.
Eye disorders Retained lens material	1.0% 1/99 • 6 Months Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. Safety analysis set included all participants for whom a study IOL touched the eye.	0.00% 0/99 • 6 Months Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. Safety analysis set included all participants for whom a study IOL touched the eye.
Eye disorders Clinically significant cystoid macular edema	2.0% 2/99 • 6 Months Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. Safety analysis set included all participants for whom a study IOL touched the eye.	3.0% 3/99 • 6 Months Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. Safety analysis set included all participants for whom a study IOL touched the eye.
Eye disorders Rebound Iritis	0.00% 0/99 • 6 Months Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. Safety analysis set included all participants for whom a study IOL touched the eye.	1.0% 1/99 • 6 Months Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. Safety analysis set included all participants for whom a study IOL touched the eye.

Other adverse events

Adverse event data not reported

Additional Information

Xu Cheng

Johnson & Johnson Surgical Vision

Phone: 1904 4431245

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publication restrictions are in place

Restriction type: OTHER

Measure	Investigational Lens Device n=100 Participants Investigational IOL Model DEN00V	Control Lens Device n=102 Participants Control IOL Model ZCB00/DCB00	Total n=202 Participants Total of all reporting groups
Age, Customized <60 years old	12 Participants n=54 Participants • Baseline measurements are based on the ITT population.	3 Participants n=54 Participants • Baseline measurements are based on the ITT population.	15 Participants n=27 Participants • Baseline measurements are based on the ITT population.
Age, Customized 60-69 years old	35 Participants n=54 Participants • Baseline measurements are based on the ITT population.	43 Participants n=54 Participants • Baseline measurements are based on the ITT population.	78 Participants n=27 Participants • Baseline measurements are based on the ITT population.
Age, Customized 70-79 years old	48 Participants n=54 Participants • Baseline measurements are based on the ITT population.	47 Participants n=54 Participants • Baseline measurements are based on the ITT population.	95 Participants n=27 Participants • Baseline measurements are based on the ITT population.
Age, Customized >=80 years old	5 Participants n=54 Participants • Baseline measurements are based on the ITT population.	9 Participants n=54 Participants • Baseline measurements are based on the ITT population.	14 Participants n=27 Participants • Baseline measurements are based on the ITT population.
Sex: Female, Male Sex · Female	65 Participants n=54 Participants • Baseline measurements are based on the ITT population.	62 Participants n=54 Participants • Baseline measurements are based on the ITT population.	127 Participants n=27 Participants • Baseline measurements are based on the ITT population.
Sex: Female, Male Sex · Male	35 Participants n=54 Participants • Baseline measurements are based on the ITT population.	40 Participants n=54 Participants • Baseline measurements are based on the ITT population.	75 Participants n=27 Participants • Baseline measurements are based on the ITT population.
Ethnicity (NIH/OMB) Ethnicity · Hispanic or Latino	14 Participants n=54 Participants • Baseline measurements are based on the ITT population.	12 Participants n=54 Participants • Baseline measurements are based on the ITT population.	26 Participants n=27 Participants • Baseline measurements are based on the ITT population.
Ethnicity (NIH/OMB) Ethnicity · Not Hispanic or Latino	86 Participants n=54 Participants • Baseline measurements are based on the ITT population.	90 Participants n=54 Participants • Baseline measurements are based on the ITT population.	176 Participants n=27 Participants • Baseline measurements are based on the ITT population.
Ethnicity (NIH/OMB) Ethnicity · Unknown or Not Reported	0 Participants n=54 Participants • Baseline measurements are based on the ITT population.	0 Participants n=54 Participants • Baseline measurements are based on the ITT population.	0 Participants n=27 Participants • Baseline measurements are based on the ITT population.
Race (NIH/OMB) Race · American Indian or Alaska Native	0 Participants n=54 Participants • Baseline measurements are based on the ITT population.	0 Participants n=54 Participants • Baseline measurements are based on the ITT population.	0 Participants n=27 Participants • Baseline measurements are based on the ITT population.
Race (NIH/OMB) Race · Asian	7 Participants n=54 Participants • Baseline measurements are based on the ITT population.	10 Participants n=54 Participants • Baseline measurements are based on the ITT population.	17 Participants n=27 Participants • Baseline measurements are based on the ITT population.
Race (NIH/OMB) Race · Native Hawaiian or Other Pacific Islander	0 Participants n=54 Participants • Baseline measurements are based on the ITT population.	0 Participants n=54 Participants • Baseline measurements are based on the ITT population.	0 Participants n=27 Participants • Baseline measurements are based on the ITT population.
Race (NIH/OMB) Race · Black or African American	6 Participants n=54 Participants • Baseline measurements are based on the ITT population.	11 Participants n=54 Participants • Baseline measurements are based on the ITT population.	17 Participants n=27 Participants • Baseline measurements are based on the ITT population.
Race (NIH/OMB) Race · White	87 Participants n=54 Participants • Baseline measurements are based on the ITT population.	80 Participants n=54 Participants • Baseline measurements are based on the ITT population.	167 Participants n=27 Participants • Baseline measurements are based on the ITT population.
Race (NIH/OMB) Race · More than one race	0 Participants n=54 Participants • Baseline measurements are based on the ITT population.	1 Participants n=54 Participants • Baseline measurements are based on the ITT population.	1 Participants n=27 Participants • Baseline measurements are based on the ITT population.
Race (NIH/OMB) Race · Unknown or Not Reported	0 Participants n=54 Participants • Baseline measurements are based on the ITT population.	0 Participants n=54 Participants • Baseline measurements are based on the ITT population.	0 Participants n=27 Participants • Baseline measurements are based on the ITT population.