Trial Outcomes & Findings for Evaluate the Safety and Effectiveness of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens (NCT NCT03603600)
NCT ID: NCT03603600
Last Updated: 2024-12-24
Results Overview
Photopic monocular best-corrected distance visual acuity (BCDVA) in first eyes at Post-Operative Visit 4 (Day 120 to 180 after second eye implantation eyes at Post-Operative Visit 4 (Day 120 to 180 after second eye implantation)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
501 participants
Primary outcome timeframe
Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
Results posted on
2024-12-24
Participant Flow
Participant milestones
| Measure |
enVista MX60EF
enVista MX60EF (trifocal) multifocal IOL (MIOL)
enVista MX60EF: enVista MX60EF (trifocal) multifocal IOL (MIOL)
|
enVista MX60E
enVista MX60E monofocal IOL
enVista MX60E: enVista MX60E monofocal IOL
|
|---|---|---|
|
Overall Study
STARTED
|
332
|
169
|
|
Overall Study
COMPLETED
|
319
|
157
|
|
Overall Study
NOT COMPLETED
|
13
|
12
|
Reasons for withdrawal
| Measure |
enVista MX60EF
enVista MX60EF (trifocal) multifocal IOL (MIOL)
enVista MX60EF: enVista MX60EF (trifocal) multifocal IOL (MIOL)
|
enVista MX60E
enVista MX60E monofocal IOL
enVista MX60E: enVista MX60E monofocal IOL
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Death
|
3
|
1
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Other reason
|
1
|
0
|
Baseline Characteristics
Evaluate the Safety and Effectiveness of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens
Baseline characteristics by cohort
| Measure |
enVista MX60EF
n=332 Participants
enVista MX60EF (trifocal) multifocal IOL (MIOL)
enVista MX60EF: enVista MX60EF (trifocal) multifocal IOL (MIOL)
|
enVista MX60E
n=169 Participants
enVista MX60E monofocal IOL
enVista MX60E: enVista MX60E monofocal IOL
|
Total
n=501 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.6 years
STANDARD_DEVIATION 7.89 • n=5 Participants
|
68.8 years
STANDARD_DEVIATION 7.46 • n=7 Participants
|
68.0 years
STANDARD_DEVIATION 7.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
212 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
320 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
40 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
292 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
441 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 (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
305 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
461 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
322 participants
n=5 Participants
|
169 participants
n=7 Participants
|
501 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.Photopic monocular best-corrected distance visual acuity (BCDVA) in first eyes at Post-Operative Visit 4 (Day 120 to 180 after second eye implantation eyes at Post-Operative Visit 4 (Day 120 to 180 after second eye implantation)
Outcome measures
| Measure |
enVista MX60EF
n=312 Participants
enVista MX60EF (trifocal) multifocal IOL (MIOL)
enVista MX60EF: enVista MX60EF (trifocal) multifocal IOL (MIOL)
|
enVista MX60E
n=156 Participants
enVista MX60E monofocal IOL
enVista MX60E: enVista MX60E monofocal IOL
|
|---|---|---|
|
Photopic Monocular Best-corrected Distance Visual Acuity (BCDVA)
|
0.022 logMAR
Standard Deviation 0.0950
|
-0.017 logMAR
Standard Deviation 0.0897
|
PRIMARY outcome
Timeframe: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.Population: Modified Intent to Treat Set Excluding Phase I Subjects
Photopic monocular distance-corrected near visual acuity (DCNVA) in first eyes at 40 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)
Outcome measures
| Measure |
enVista MX60EF
n=297 Participants
enVista MX60EF (trifocal) multifocal IOL (MIOL)
enVista MX60EF: enVista MX60EF (trifocal) multifocal IOL (MIOL)
|
enVista MX60E
n=152 Participants
enVista MX60E monofocal IOL
enVista MX60E: enVista MX60E monofocal IOL
|
|---|---|---|
|
Photopic Monocular Distance-corrected Near Visual Acuity (DCNVA)
|
0.152 logMAR
Standard Deviation 0.1342
|
0.545 logMAR
Standard Deviation 0.1703
|
PRIMARY outcome
Timeframe: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.Population: Modified Intent to Treat Set Excluding Phase I Subjects
Photopic monocular distance-corrected intermediate visual acuity (DCIVA) in first eyes at 66 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation
Outcome measures
| Measure |
enVista MX60EF
n=297 Participants
enVista MX60EF (trifocal) multifocal IOL (MIOL)
enVista MX60EF: enVista MX60EF (trifocal) multifocal IOL (MIOL)
|
enVista MX60E
n=152 Participants
enVista MX60E monofocal IOL
enVista MX60E: enVista MX60E monofocal IOL
|
|---|---|---|
|
Photopic Monocular Distance-corrected Intermediate Visual Acuity (DCIVA)
|
0.122 logMAR
Standard Deviation 0.1199
|
0.349 logMAR
Standard Deviation 0.1592
|
PRIMARY outcome
Timeframe: Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baselinePopulation: Modified Safety Set: The Modified Safety Set included all subjects with at least 1 eye in which the IOL touched the eye with a study lens.
All ocular SAEs, including secondary surgical interventions (SSIs) related to the optical properties of the IOL, in first eyes through study exit
Outcome measures
| Measure |
enVista MX60EF
n=332 Participants
enVista MX60EF (trifocal) multifocal IOL (MIOL)
enVista MX60EF: enVista MX60EF (trifocal) multifocal IOL (MIOL)
|
enVista MX60E
n=169 Participants
enVista MX60E monofocal IOL
enVista MX60E: enVista MX60E monofocal IOL
|
|---|---|---|
|
Serious Adverse Events
Seidel test positive
|
1 Participants
|
0 Participants
|
|
Serious Adverse Events
Macular hole
|
1 Participants
|
0 Participants
|
|
Serious Adverse Events
Retinal tear
|
1 Participants
|
0 Participants
|
|
Serious Adverse Events
Retinal vein occlusion
|
1 Participants
|
0 Participants
|
|
Serious Adverse Events
Ophthalmic herpes zoster
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baselinePopulation: Modified Safety Set: The Modified Safety Set included all subjects with at least 1 eye in which the IOL touched the eye with a study lens.
The cumulative rate of secondary surgical interventions (SSI) due to the optical properties of the lens for first eyes through study exit. The rate was determined as the number of first eyes with an SSI related to the optical properties of the IOL divided by the total number of first eyes.
Outcome measures
| Measure |
enVista MX60EF
n=332 Participants
enVista MX60EF (trifocal) multifocal IOL (MIOL)
enVista MX60EF: enVista MX60EF (trifocal) multifocal IOL (MIOL)
|
enVista MX60E
n=169 Participants
enVista MX60E monofocal IOL
enVista MX60E: enVista MX60E monofocal IOL
|
|---|---|---|
|
The Rate of SSIs Due to the Optical Properties of the Lens for First Eyes Through Study Exit
|
0 first eyes
|
0 first eyes
|
PRIMARY outcome
Timeframe: Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baselinePopulation: The measure was not assessed for the control arm.
The cumulative rate of secondary surgical interventions (SSI) due to the optical properties of the lens for first eyes through study exit. The rate was determined as the number of first eyes with an SSI related to the optical properties of the IOL divided by the total number of first eyes
Outcome measures
| Measure |
enVista MX60EF
n=332 Participants
enVista MX60EF (trifocal) multifocal IOL (MIOL)
enVista MX60EF: enVista MX60EF (trifocal) multifocal IOL (MIOL)
|
enVista MX60E
enVista MX60E monofocal IOL
enVista MX60E: enVista MX60E monofocal IOL
|
|---|---|---|
|
The Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint
Cystoid macular oedema
|
0 first eyes
|
—
|
|
The Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint
Hypopyon
|
0 first eyes
|
—
|
|
The Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint
Endophthalmitis
|
0 first eyes
|
—
|
|
The Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint
Lens dislocated from posterior chamber
|
0 first eyes
|
—
|
|
The Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint
Pupillary block
|
0 first eyes
|
—
|
|
The Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint
Retinal detachment
|
0 first eyes
|
—
|
|
The Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint
SSI
|
0 first eyes
|
—
|
SECONDARY outcome
Timeframe: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.Population: Modified Intent to Treat Set Excluding Phase I Subjects
Photopic binocular distance-corrected near visual acuity (DCNVA) at 40 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)
Outcome measures
| Measure |
enVista MX60EF
n=284 Participants
enVista MX60EF (trifocal) multifocal IOL (MIOL)
enVista MX60EF: enVista MX60EF (trifocal) multifocal IOL (MIOL)
|
enVista MX60E
n=142 Participants
enVista MX60E monofocal IOL
enVista MX60E: enVista MX60E monofocal IOL
|
|---|---|---|
|
Photopic Binocular DCNVA at 40 cm at Postoperative Visit 4
|
0.080 logMAR
Standard Deviation 0.0977
|
0.453 logMAR
Standard Deviation 0.1526
|
SECONDARY outcome
Timeframe: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.Population: Modified Intent to Treat Set Excluding Phase I Subjects
Photopic binocular uncorrected near visual acuity (UNVA) at 40 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)
Outcome measures
| Measure |
enVista MX60EF
n=297 Participants
enVista MX60EF (trifocal) multifocal IOL (MIOL)
enVista MX60EF: enVista MX60EF (trifocal) multifocal IOL (MIOL)
|
enVista MX60E
n=153 Participants
enVista MX60E monofocal IOL
enVista MX60E: enVista MX60E monofocal IOL
|
|---|---|---|
|
Photopic Binocular UNVA at 40 cm at Postoperative Visit 4
|
0.096 logMAR
Standard Deviation 0.1056
|
0.418 logMAR
Standard Deviation 0.1454
|
SECONDARY outcome
Timeframe: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.Population: Modified Intent to Treat Set Excluding Phase I Subjects
Photopic binocular distance-corrected intermediate visual acuity (DCIVA) at 66 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)
Outcome measures
| Measure |
enVista MX60EF
n=283 Participants
enVista MX60EF (trifocal) multifocal IOL (MIOL)
enVista MX60EF: enVista MX60EF (trifocal) multifocal IOL (MIOL)
|
enVista MX60E
n=142 Participants
enVista MX60E monofocal IOL
enVista MX60E: enVista MX60E monofocal IOL
|
|---|---|---|
|
Photopic Binocular DCIVA at 66 cm at Postoperative Visit 4
|
0.041 logMAR
Standard Deviation 0.0976
|
0.268 logMAR
Standard Deviation 0.1485
|
SECONDARY outcome
Timeframe: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.Population: Modified Intent to Treat Set Excluding Phase I Subjects
Photopic binocular uncorrected intermediate visual acuity (UIVA) at 66 cm at Postoperative Visit 4 (Day 120 to Day 180 after second eye implantation)
Outcome measures
| Measure |
enVista MX60EF
n=297 Participants
enVista MX60EF (trifocal) multifocal IOL (MIOL)
enVista MX60EF: enVista MX60EF (trifocal) multifocal IOL (MIOL)
|
enVista MX60E
n=153 Participants
enVista MX60E monofocal IOL
enVista MX60E: enVista MX60E monofocal IOL
|
|---|---|---|
|
Photopic Binocular UIVA at 66 cm at Postoperative Visit 4
|
0.064 logMAR
Standard Deviation 0.0988
|
0.217 logMAR
Standard Deviation 0.1442
|
SECONDARY outcome
Timeframe: Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baselinePopulation: Modified Intent to Treat Set
First-eye BCDVA evaluated at Postoperative Visit 5 (Day 330 to Day 420 after second eye implantation)
Outcome measures
| Measure |
enVista MX60EF
n=308 Participants
enVista MX60EF (trifocal) multifocal IOL (MIOL)
enVista MX60EF: enVista MX60EF (trifocal) multifocal IOL (MIOL)
|
enVista MX60E
n=152 Participants
enVista MX60E monofocal IOL
enVista MX60E: enVista MX60E monofocal IOL
|
|---|---|---|
|
First-eye BCDVA Evaluated at Postoperative Visit 5
|
0.027 logMAR
Standard Deviation 0.0920
|
-0.020 logMAR
Standard Deviation 0.0826
|
SECONDARY outcome
Timeframe: Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baselinePopulation: Modified Intent to Treat Set Excluding Phase I Subjects
First-eye DCNVA evaluated at Postoperative Visit 5 (Day 330 to Day 420 after second eye implantation)
Outcome measures
| Measure |
enVista MX60EF
n=280 Participants
enVista MX60EF (trifocal) multifocal IOL (MIOL)
enVista MX60EF: enVista MX60EF (trifocal) multifocal IOL (MIOL)
|
enVista MX60E
n=139 Participants
enVista MX60E monofocal IOL
enVista MX60E: enVista MX60E monofocal IOL
|
|---|---|---|
|
First-eye DCNVA Evaluated at Postoperative Visit 5
|
0.143 logMAR
Standard Deviation 0.1284
|
0.533 logMAR
Standard Deviation 0.1843
|
SECONDARY outcome
Timeframe: Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baselinePopulation: Modified Intent to Treat Set Excluding Phase I Subjects
First-eye DCIVA evaluated at Postoperative Visit 5 (Day 330 to Day 420 after second eye implantation)
Outcome measures
| Measure |
enVista MX60EF
n=280 Participants
enVista MX60EF (trifocal) multifocal IOL (MIOL)
enVista MX60EF: enVista MX60EF (trifocal) multifocal IOL (MIOL)
|
enVista MX60E
n=139 Participants
enVista MX60E monofocal IOL
enVista MX60E: enVista MX60E monofocal IOL
|
|---|---|---|
|
First-eye DCIVA Evaluated at Postoperative Visit 5
|
0.120 logMAR
Standard Deviation 0.1147
|
0.343 logMAR
Standard Deviation 0.1594
|
Adverse Events
enVista MX60EF
Serious events: 17 serious events
Other events: 120 other events
Deaths: 3 deaths
enVista MX60E
Serious events: 15 serious events
Other events: 47 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
enVista MX60EF
n=332 participants at risk
enVista MX60EF (trifocal) multifocal IOL (MIOL) Subjects implanted with enVista MX60EF trifocal intraocular lenses (IOLs). For ocular AEs, the number of eyes at risk were 661 for the enVista MX60EF trifocal intraocular lens (IOL) group
|
enVista MX60E
n=169 participants at risk
enVista MX60E monofocal IOL Subjects implanted with enVista MX60E monofocal intraocular lenses (IOLs). For ocular AEs, the number of eyes at risk were 337 for the enVista MX60E monofocal intraocular lens (IOL) group.
|
|---|---|---|
|
Eye disorders
Macular hole
|
0.30%
1/332 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.00%
0/169 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Eye disorders
Retinal tear
|
0.30%
1/332 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.00%
0/169 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Eye disorders
Retinal vein occlusion
|
0.30%
1/332 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.00%
0/169 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Infections and infestations
Endophthalmitis
|
0.30%
1/332 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.00%
0/169 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.00%
0/332 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.59%
1/169 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Injury, poisoning and procedural complications
Cataract operation complication
|
0.00%
0/332 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.59%
1/169 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Investigations
Seidel test positive
|
0.30%
1/332 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.00%
0/169 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Nervous system disorders
Cerebrovascular accident
|
0.60%
2/332 • Number of events 2 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
1.2%
2/169 • Number of events 2 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Nervous system disorders
Myelopathy
|
0.30%
1/332 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.00%
0/169 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Nervous system disorders
Presyncope
|
0.00%
0/332 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.59%
1/169 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Nervous system disorders
Syncope
|
0.30%
1/332 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.00%
0/169 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/332 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.59%
1/169 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
|
0.00%
0/332 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.59%
1/169 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.30%
1/332 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.00%
0/169 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/332 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.59%
1/169 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.30%
1/332 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.00%
0/169 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour
|
0.30%
1/332 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.00%
0/169 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.30%
1/332 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.00%
0/169 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
General disorders
Chest pain
|
0.00%
0/332 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
1.2%
2/169 • Number of events 2 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Eye disorders
Multiple organ dysfunction syndrome
|
0.00%
0/332 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.59%
1/169 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Infections and infestations
Cellulitis
|
0.00%
0/332 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.59%
1/169 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/332 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.59%
1/169 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.30%
1/332 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.00%
0/169 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.30%
1/332 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.00%
0/169 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/332 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.59%
1/169 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Injury, poisoning and procedural complications
Fall
|
0.30%
1/332 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.00%
0/169 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/332 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.59%
1/169 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.30%
1/332 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.00%
0/169 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/332 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
0.59%
1/169 • Number of events 1 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
Other adverse events
| Measure |
enVista MX60EF
n=332 participants at risk
enVista MX60EF (trifocal) multifocal IOL (MIOL) Subjects implanted with enVista MX60EF trifocal intraocular lenses (IOLs). For ocular AEs, the number of eyes at risk were 661 for the enVista MX60EF trifocal intraocular lens (IOL) group
|
enVista MX60E
n=169 participants at risk
enVista MX60E monofocal IOL Subjects implanted with enVista MX60E monofocal intraocular lenses (IOLs). For ocular AEs, the number of eyes at risk were 337 for the enVista MX60E monofocal intraocular lens (IOL) group.
|
|---|---|---|
|
Eye disorders
Punctate keratitis
|
17.2%
57/332 • Number of events 57 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
9.5%
16/169 • Number of events 16 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Investigations
Intraocular pressure increased
|
13.0%
43/332 • Number of events 43 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
12.4%
21/169 • Number of events 21 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
|
Eye disorders
Vitreous detachment
|
9.6%
32/332 • Number of events 32 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
7.1%
12/169 • Number of events 12 • Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Ocular Adverse Events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Contact Sponsor directly for details
- Publication restrictions are in place
Restriction type: OTHER