Trial Outcomes & Findings for Vision Performance Evaluation of TECNIS EYHANCE™ With TECNIS SIMPLICITY™ Compared to TECNIS® 1-piece Intraocular Lenses (NCT NCT05025345)
NCT ID: NCT05025345
Last Updated: 2023-08-28
Results Overview
the mean monocular difference in Best-Corrected Distance Visual Acuity for the first eye between lens groups
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
228 participants
Primary outcome timeframe
6 months
Results posted on
2023-08-28
Participant Flow
A total of 228 subjects were enrolled and 214 subjects were treated. Of the 214 subjects, 107 were implanted with the test lens and 107 with the control lens. 4 subjects did not complete the study.
Participant milestones
| Measure |
Test Lens
Eyhance IOL, Model DIB00
|
Control Lens
Monofocal IOL, Model ZCB00
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
107
|
|
Overall Study
COMPLETED
|
103
|
107
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vision Performance Evaluation of TECNIS EYHANCE™ With TECNIS SIMPLICITY™ Compared to TECNIS® 1-piece Intraocular Lenses
Baseline characteristics by cohort
| Measure |
Test Lens
n=107 Participants
Eyhance IOL, Model DIB00
|
Control Lens
n=107 Participants
Monofocal IOL, Model ZCB00
|
Total
n=214 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<60
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Customized
60-69
|
47 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Age, Customized
70-79
|
42 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Age, Customized
>=80
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
89 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
181 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)
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/ Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
95 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other Race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The ITT (Intent-to-Treat) 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)
the mean monocular difference in Best-Corrected Distance Visual Acuity for the first eye between lens groups
Outcome measures
| Measure |
Test Lens
n=103 Eyes
Eyhance IOL, Model DIB00
|
Control Lens
n=107 Eyes
Monofocal IOL, Model ZCB00
|
|---|---|---|
|
MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA)
|
-0.017 LogMAR
Standard Deviation 0.090
|
-0.029 LogMAR
Standard Deviation 0.116
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The ITT (Intent-to-Treat) population for monocular first-eye distance-corrected intermediate visual acuity at 66cm (DCVA66) include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation).
the mean monocular difference in Distance-Corrected Intermediate Visual Acuity at 66cm for first eyes between lens groups
Outcome measures
| Measure |
Test Lens
n=103 Eyes
Eyhance IOL, Model DIB00
|
Control Lens
n=107 Eyes
Monofocal IOL, Model ZCB00
|
|---|---|---|
|
MONOCULAR DISTANCE-CORRECTED INTERMEDIATE VISUAL ACUITY AT 66 CM (DCVA66)
|
0.235 LogMAR
Standard Deviation 0.169
|
0.348 LogMAR
Standard Deviation 0.158
|
Adverse Events
Test Lens
Serious events: 5 serious events
Other events: 1 other events
Deaths: 2 deaths
Control Lens
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test Lens
n=107 participants at risk
Eyhance IOL, Model DIB00
|
Control Lens
n=107 participants at risk
Monofocal IOL, Model ZCB00
|
|---|---|---|
|
Eye disorders
Cystoid macular edema
|
0.93%
1/107 • Number of events 1 • During the course of the study until completion, 6 months.
All adverse events (AEs), ocular and non-ocular, were monitored/assessed and planned to be reported for the first eye only. Second eye was not assessed for adverse events.
|
1.9%
2/107 • Number of events 4 • During the course of the study until completion, 6 months.
All adverse events (AEs), ocular and non-ocular, were monitored/assessed and planned to be reported for the first eye only. Second eye was not assessed for adverse events.
|
|
Blood and lymphatic system disorders
Lymphoma
|
0.93%
1/107 • Number of events 1 • During the course of the study until completion, 6 months.
All adverse events (AEs), ocular and non-ocular, were monitored/assessed and planned to be reported for the first eye only. Second eye was not assessed for adverse events.
|
0.00%
0/107 • During the course of the study until completion, 6 months.
All adverse events (AEs), ocular and non-ocular, were monitored/assessed and planned to be reported for the first eye only. Second eye was not assessed for adverse events.
|
|
Surgical and medical procedures
Hospitalization
|
0.93%
1/107 • Number of events 1 • During the course of the study until completion, 6 months.
All adverse events (AEs), ocular and non-ocular, were monitored/assessed and planned to be reported for the first eye only. Second eye was not assessed for adverse events.
|
0.93%
1/107 • Number of events 1 • During the course of the study until completion, 6 months.
All adverse events (AEs), ocular and non-ocular, were monitored/assessed and planned to be reported for the first eye only. Second eye was not assessed for adverse events.
|
|
Blood and lymphatic system disorders
Refractory Cytopenia with Multilineage Dysplasia
|
0.93%
1/107 • Number of events 1 • During the course of the study until completion, 6 months.
All adverse events (AEs), ocular and non-ocular, were monitored/assessed and planned to be reported for the first eye only. Second eye was not assessed for adverse events.
|
0.00%
0/107 • During the course of the study until completion, 6 months.
All adverse events (AEs), ocular and non-ocular, were monitored/assessed and planned to be reported for the first eye only. Second eye was not assessed for adverse events.
|
|
Cardiac disorders
Mitral Valve Defect
|
0.93%
1/107 • Number of events 1 • During the course of the study until completion, 6 months.
All adverse events (AEs), ocular and non-ocular, were monitored/assessed and planned to be reported for the first eye only. Second eye was not assessed for adverse events.
|
0.00%
0/107 • During the course of the study until completion, 6 months.
All adverse events (AEs), ocular and non-ocular, were monitored/assessed and planned to be reported for the first eye only. Second eye was not assessed for adverse events.
|
|
Eye disorders
Ischemic Optic Neuropathy
|
0.00%
0/107 • During the course of the study until completion, 6 months.
All adverse events (AEs), ocular and non-ocular, were monitored/assessed and planned to be reported for the first eye only. Second eye was not assessed for adverse events.
|
0.93%
1/107 • Number of events 1 • During the course of the study until completion, 6 months.
All adverse events (AEs), ocular and non-ocular, were monitored/assessed and planned to be reported for the first eye only. Second eye was not assessed for adverse events.
|
Other adverse events
| Measure |
Test Lens
n=107 participants at risk
Eyhance IOL, Model DIB00
|
Control Lens
n=107 participants at risk
Monofocal IOL, Model ZCB00
|
|---|---|---|
|
Eye disorders
Undesirable Optical Phenomena
|
0.93%
1/107 • Number of events 1 • During the course of the study until completion, 6 months.
All adverse events (AEs), ocular and non-ocular, were monitored/assessed and planned to be reported for the first eye only. Second eye was not assessed for adverse events.
|
0.00%
0/107 • During the course of the study until completion, 6 months.
All adverse events (AEs), ocular and non-ocular, were monitored/assessed and planned to be reported for the first eye only. Second eye was not assessed for adverse events.
|
Additional Information
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