Trial Outcomes & Findings for Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens (NCT NCT06377514)
NCT ID: NCT06377514
Last Updated: 2026-07-17
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
COMPLETED
Study phase
NA
Target enrollment
245 participants
Primary outcome timeframe
6 months
Results posted on
2026-07-17
Participant Flow
Prospective, multicenter, bilateral, interventional, controlled, masked, randomized, clinical investigation of the DEN00V IOL (EDF; test) and the DCB00 IOL (monofocal; control). Enrollment targeted up to 250 subjects at up to 10 sites to achieve \~200 bilaterally implanted subjects (100 per group) evaluable at 6 months.
Out of 245 enrolled participants a total of 228 participants were randomized in this study.
Participant milestones
| Measure |
Test IOL
Investigational IOL Model DEN00V
|
Control IOL
Control Monofocal IOL Model DCB00
|
|---|---|---|
|
Overall Study
STARTED
|
116
|
112
|
|
Overall Study
Intent to Treat Population
|
116
|
112
|
|
Overall Study
Safety Population
|
115
|
113
|
|
Overall Study
COMPLETED
|
114
|
109
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Test IOL
Investigational IOL Model DEN00V
|
Control IOL
Control Monofocal IOL Model DCB00
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
Baseline Characteristics
Baseline measurements are based on the ITT population.
Baseline characteristics by cohort
| Measure |
Test IOL
n=116 Participants
Investigational IOL Model DEN00V
|
Control IOL
n=112 Participants
Control Monofocal IOL Model DCB00
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<65 years old
|
26 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
26 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
52 Participants
n=40 Participants • Baseline measurements are based on the ITT population.
|
|
Age, Customized
>=65 years old
|
90 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
86 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
176 Participants
n=40 Participants • Baseline measurements are based on the ITT population.
|
|
Sex: Female, Male
Sex · Female
|
72 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
69 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
141 Participants
n=40 Participants • Baseline measurements are based on the ITT population.
|
|
Sex: Female, Male
Sex · Male
|
44 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
43 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
87 Participants
n=40 Participants • Baseline measurements are based on the ITT population.
|
|
Ethnicity (NIH/OMB)
Ethnicity · Hispanic or Latino
|
18 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
10 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
28 Participants
n=40 Participants • Baseline measurements are based on the ITT population.
|
|
Ethnicity (NIH/OMB)
Ethnicity · Not Hispanic or Latino
|
98 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
102 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
200 Participants
n=40 Participants • Baseline measurements are based on the ITT population.
|
|
Ethnicity (NIH/OMB)
Ethnicity · Unknown or Not Reported
|
0 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
0 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
0 Participants
n=40 Participants • Baseline measurements are based on the ITT population.
|
|
Race (NIH/OMB)
Race · American Indian or Alaska Native
|
0 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
1 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
1 Participants
n=40 Participants • Baseline measurements are based on the ITT population.
|
|
Race (NIH/OMB)
Race · Asian
|
5 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
3 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
8 Participants
n=40 Participants • Baseline measurements are based on the ITT population.
|
|
Race (NIH/OMB)
Race · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
0 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
1 Participants
n=40 Participants • Baseline measurements are based on the ITT population.
|
|
Race (NIH/OMB)
Race · Black or African American
|
14 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
15 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
29 Participants
n=40 Participants • Baseline measurements are based on the ITT population.
|
|
Race (NIH/OMB)
Race · White
|
93 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
92 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
185 Participants
n=40 Participants • Baseline measurements are based on the ITT population.
|
|
Race (NIH/OMB)
Race · More than one race
|
0 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
0 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
0 Participants
n=40 Participants • Baseline measurements are based on the ITT population.
|
|
Race (NIH/OMB)
Race · Unknown or Not Reported
|
3 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
1 Participants
n=20 Participants • Baseline measurements are based on the ITT population.
|
4 Participants
n=40 Participants • Baseline measurements are based on the ITT population.
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Intent To Treat Population
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.
Outcome measures
| Measure |
Test IOL
n=116 Eyes
Investigational IOL Model DEN00V
|
Control IOL
n=112 Eyes
Control Monofocal IOL Model DCB00
|
|---|---|---|
|
Monocular (First Eyes) Photopic DCIVA at 66 cm
|
0.15 logMAR
Standard Error 0.011
|
0.31 logMAR
Standard Error 0.014
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Intent To Treated 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
| Measure |
Test IOL
n=116 Eyes
Investigational IOL Model DEN00V
|
Control IOL
n=112 Eyes
Control Monofocal IOL Model DCB00
|
|---|---|---|
|
Monocular (First Eyes) Depth of Focus
|
-1.77 Diopter
Interval to -1.77
|
-1.13 Diopter
Interval to -1.13
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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
| Measure |
Test IOL
n=116 Eyes
Investigational IOL Model DEN00V
|
Control IOL
n=112 Eyes
Control Monofocal IOL Model DCB00
|
|---|---|---|
|
Monocular (First Eyes) Photopic BCDVA at 4m
|
-0.04 logMAR
Standard Error 0.008
|
-0.08 logMAR
Standard Error 0.009
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Intent To Treat Population
Monocular photopic Distance Corrected Visual Acuity (DCVA) in logMAR at 100 cm for first eyes. This analysis was prespecified for the first operative eye.
Outcome measures
| Measure |
Test IOL
n=116 Eyes
Investigational IOL Model DEN00V
|
Control IOL
n=112 Eyes
Control Monofocal IOL Model DCB00
|
|---|---|---|
|
Monocular (First Eyes) Photopic DCVA at 100 cm
|
0.10 logMAR
Standard Error 0.012
|
0.16 logMAR
Standard Error 0.013
|
Adverse Events
Test IOL
Serious events: 13 serious events
Other events: 3 other events
Deaths: 2 deaths
Control IOL
Serious events: 8 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test IOL
n=115 participants at risk
Investigational IOL Model DEN00V
|
Control IOL
n=113 participants at risk
Control Monofocal IOL Model DCB00
|
|---|---|---|
|
Eye disorders
Increased IOP
|
4.3%
5/115 • 6 months
Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. One participant was randomized to test IOL but instead received the control IOL. Therefore, there are 115 investigational IOL Model DEN00V participants and 113 Control Monofocal IOL Model DCB00 participants in the AE section.
|
2.7%
3/113 • 6 months
Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. One participant was randomized to test IOL but instead received the control IOL. Therefore, there are 115 investigational IOL Model DEN00V participants and 113 Control Monofocal IOL Model DCB00 participants in the AE section.
|
|
Eye disorders
Retained lens material resulting in secondary surgical intervention
|
0.87%
1/115 • 6 months
Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. One participant was randomized to test IOL but instead received the control IOL. Therefore, there are 115 investigational IOL Model DEN00V participants and 113 Control Monofocal IOL Model DCB00 participants in the AE section.
|
0.00%
0/113 • 6 months
Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. One participant was randomized to test IOL but instead received the control IOL. Therefore, there are 115 investigational IOL Model DEN00V participants and 113 Control Monofocal IOL Model DCB00 participants in the AE section.
|
|
Eye disorders
Persistent cystoid macular edema
|
0.87%
1/115 • 6 months
Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. One participant was randomized to test IOL but instead received the control IOL. Therefore, there are 115 investigational IOL Model DEN00V participants and 113 Control Monofocal IOL Model DCB00 participants in the AE section.
|
0.88%
1/113 • 6 months
Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. One participant was randomized to test IOL but instead received the control IOL. Therefore, there are 115 investigational IOL Model DEN00V participants and 113 Control Monofocal IOL Model DCB00 participants in the AE section.
|
|
Eye disorders
Vitreous in Anterior Chamber
|
0.00%
0/115 • 6 months
Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. One participant was randomized to test IOL but instead received the control IOL. Therefore, there are 115 investigational IOL Model DEN00V participants and 113 Control Monofocal IOL Model DCB00 participants in the AE section.
|
0.88%
1/113 • 6 months
Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. One participant was randomized to test IOL but instead received the control IOL. Therefore, there are 115 investigational IOL Model DEN00V participants and 113 Control Monofocal IOL Model DCB00 participants in the AE section.
|
|
Eye disorders
Clinically significant cystoid macular edema
|
0.00%
0/115 • 6 months
Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. One participant was randomized to test IOL but instead received the control IOL. Therefore, there are 115 investigational IOL Model DEN00V participants and 113 Control Monofocal IOL Model DCB00 participants in the AE section.
|
0.88%
1/113 • 6 months
Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. One participant was randomized to test IOL but instead received the control IOL. Therefore, there are 115 investigational IOL Model DEN00V participants and 113 Control Monofocal IOL Model DCB00 participants in the AE section.
|
|
Hepatobiliary disorders
Liver issue
|
2.6%
3/115 • 6 months
Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. One participant was randomized to test IOL but instead received the control IOL. Therefore, there are 115 investigational IOL Model DEN00V participants and 113 Control Monofocal IOL Model DCB00 participants in the AE section.
|
1.8%
2/113 • 6 months
Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. One participant was randomized to test IOL but instead received the control IOL. Therefore, there are 115 investigational IOL Model DEN00V participants and 113 Control Monofocal IOL Model DCB00 participants in the AE section.
|
|
Skin and subcutaneous tissue disorders
Squamous Cell Carcinoma
|
0.87%
1/115 • 6 months
Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. One participant was randomized to test IOL but instead received the control IOL. Therefore, there are 115 investigational IOL Model DEN00V participants and 113 Control Monofocal IOL Model DCB00 participants in the AE section.
|
0.00%
0/113 • 6 months
Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. One participant was randomized to test IOL but instead received the control IOL. Therefore, there are 115 investigational IOL Model DEN00V participants and 113 Control Monofocal IOL Model DCB00 participants in the AE section.
|
|
Respiratory, thoracic and mediastinal disorders
Staph Infection
|
0.87%
1/115 • 6 months
Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. One participant was randomized to test IOL but instead received the control IOL. Therefore, there are 115 investigational IOL Model DEN00V participants and 113 Control Monofocal IOL Model DCB00 participants in the AE section.
|
0.00%
0/113 • 6 months
Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. One participant was randomized to test IOL but instead received the control IOL. Therefore, there are 115 investigational IOL Model DEN00V participants and 113 Control Monofocal IOL Model DCB00 participants in the AE section.
|
|
Cardiac disorders
Cardiac Arrest
|
1.7%
2/115 • 6 months
Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. One participant was randomized to test IOL but instead received the control IOL. Therefore, there are 115 investigational IOL Model DEN00V participants and 113 Control Monofocal IOL Model DCB00 participants in the AE section.
|
0.00%
0/113 • 6 months
Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. One participant was randomized to test IOL but instead received the control IOL. Therefore, there are 115 investigational IOL Model DEN00V participants and 113 Control Monofocal IOL Model DCB00 participants in the AE section.
|
Other adverse events
| Measure |
Test IOL
n=115 participants at risk
Investigational IOL Model DEN00V
|
Control IOL
n=113 participants at risk
Control Monofocal IOL Model DCB00
|
|---|---|---|
|
Eye disorders
Undesirable Optical Phenomenal
|
1.7%
2/115 • 6 months
Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. One participant was randomized to test IOL but instead received the control IOL. Therefore, there are 115 investigational IOL Model DEN00V participants and 113 Control Monofocal IOL Model DCB00 participants in the AE section.
|
2.7%
3/113 • 6 months
Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. One participant was randomized to test IOL but instead received the control IOL. Therefore, there are 115 investigational IOL Model DEN00V participants and 113 Control Monofocal IOL Model DCB00 participants in the AE section.
|
|
Eye disorders
Inadequate Visual Clarity
|
0.87%
1/115 • 6 months
Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. One participant was randomized to test IOL but instead received the control IOL. Therefore, there are 115 investigational IOL Model DEN00V participants and 113 Control Monofocal IOL Model DCB00 participants in the AE section.
|
0.00%
0/113 • 6 months
Safety Population is used for analysis of adverse event. Participants were analyzed based on the IOL received in the Safety Population. One participant was randomized to test IOL but instead received the control IOL. Therefore, there are 115 investigational IOL Model DEN00V participants and 113 Control Monofocal IOL Model DCB00 participants in the AE section.
|
Additional Information
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