Trial Outcomes & Findings for Clinical Evaluation of the Performance of the enVista® Aspire™ (EA) Lens (NCT NCT06479148)
NCT ID: NCT06479148
Last Updated: 2026-05-26
Results Overview
Photopic binocular distance corrected intermediate visual acuity (DCIVA) at 66 cm at post-operative visit 3
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
Assessed from Day 90 to Day 150
Results posted on
2026-05-26
Participant Flow
Participant milestones
| Measure |
enVista® Aspire ™
enVista® Aspire™: Eyes will receive enVista® Aspire™ lenses
|
An IOL With a Slightly Extended Depth of Focus
An IOL with a slightly extended depth of focus: Eyes will receive lenses with a slightly extended depth of focus
|
enVista® Monofocal IOL (MX60E)
Other
MX60E: Eyes will receive MX60E lenses
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
10
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Evaluation of the Performance of the enVista® Aspire™ (EA) Lens
Baseline characteristics by cohort
| Measure |
An IOL With a Slightly Extended Depth of Focus
n=10 Participants
An IOL with a slightly extended depth of focus: Eyes will receive lenses with a slightly extended depth of focus
|
enVista® Monofocal IOL (MX60E)
n=6 Participants
Other
MX60E: Eyes will receive MX60E lenses
|
Total
n=27 Participants
Total of all reporting groups
|
enVista® Aspire ™
n=11 Participants
enVista® Aspire™: Eyes will receive enVista® Aspire™ lenses
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=32 Participants
|
1 Participants
n=64 Participants
|
4 Participants
n=50 Participants
|
2 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=32 Participants
|
5 Participants
n=64 Participants
|
23 Participants
n=50 Participants
|
9 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=32 Participants
|
4 Participants
n=64 Participants
|
19 Participants
n=50 Participants
|
7 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=32 Participants
|
2 Participants
n=64 Participants
|
8 Participants
n=50 Participants
|
4 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=32 Participants
|
6 Participants
n=64 Participants
|
27 Participants
n=50 Participants
|
11 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
Honduras
|
10 participants
n=32 Participants
|
6 participants
n=64 Participants
|
27 participants
n=50 Participants
|
11 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Assessed from Day 90 to Day 150Population: Due to early termination, this outcome was not measured, as none of the subjects underwent a visit 3.
Photopic binocular distance corrected intermediate visual acuity (DCIVA) at 66 cm at post-operative visit 3
Outcome measures
Outcome data not reported
Adverse Events
enVista® Aspire ™
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
An IOL With a Slightly Extended Depth of Focus
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
enVista® Monofocal IOL (MX60E)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place