Cataract
Conditions
Brief summary
The objective of the study is to evaluate the safety and effectiveness of the enVista trifocal intraocular lens when implanted in the capsular bag.
Detailed description
Cataracts are a common condition in adults over 40 years of age, and surgical replacement of the cataractous lens with an intraocular lens (IOL) remains an effective way to restore vision to cataract patients.The objective of the study is to evaluate the safety and effectiveness of the enVista trifocal intraocular lens when implanted in the capsular bag.
Interventions
DEVICEenVista MX60E
enVista MX60E monofocal IOL
DEVICEenVista MX60EF
enVista MX60EF (trifocal) multifocal IOL (MIOL)
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The Investigator implanting the IOL and designated site personnel will be unmasked to the assignment of IOLs. Subjects and designated postoperative evaluator(s) will be masked to the IOLs assigned.
Intervention model description
Approximately 334 subjects will be implanted bilaterally with the enVista MX60EF trifocal MIOL, and approximately 167 control subjects will be implanted bilaterally with the enVista MX60E monofocal IOL
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subjects must be 22 years of age or older on the date the Informed Consent Form (ICF) is signed. 2. Subjects must have the capability to understand and provide written informed consent on the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form (ICF) and authorization as appropriate for local privacy regulations. 3. Subjects must have a BCDVA equal to or worse than 20/40 in each eye, with or without a glare source, due to a clinically significant cataract (cortical, nuclear, subcapsular, or combination) that is considered amenable to treatment with standard phacoemulsification cataract extraction and capsular IOL implantation. 4. Subjects must have a BCDVA projected to be better than 20/32 after IOL implantation in each eye, as determined by the medical judgment of the Investigator or measured by potential acuity meter (PAM) testing, if necessary. 5. Subjects must have clear intraocular media other than the cataract in both eyes. 6. Contact lens wearers must demonstrate a stable refraction (within ±0.50 D for both sphere and cylinder) in both eyes, as determined by distance manifest refraction on two consecutive examination dates after discontinuation of contact lens wear. 7. Subjects must require an IOL power from +16.0 diopter (D) to +24.0 D in both eyes. 8. Subjects must be willing and able to comply with all treatment and follow-up study visits and procedures, and to undergo second eye surgery within 7-30 days of the first eye surgery.
Exclusion criteria
1. Subjects who have used an investigational drug or device within 30 days prior to entry into this study and/or will participate in another investigation during the period of study participation. 2. Subjects who have any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in either eye. 3. Subjects who have significant anterior segment pathology that might increase intraoperative risk or compromise IOL stability (e.g., pseudoexfoliation syndrome, synechiae, iris atrophy, traumatic cataract, lens subluxation, traumatic zonulolysis, zonular dialysis, evident zonular weakness or dehiscence, hypermature or brunescent cataract, etc.) in either eye. 4. Subjects who have uncontrolled glaucoma in either eye. 5. Subjects who have previous retinal detachment or clinically significant retinal pathology involving the macula in either eye. 6. Subjects who have proliferative or non-proliferative diabetic retinopathy in either eye. 7. Subjects who have a congenital ocular anomaly (e.g., aniridia, congenital cataract) in either eye. 8. Subjects using any systemic or topical drug known to interfere with visual performance, pupil dilation, or iris structure within 30 days of enrollment or during the study (refer to the relevant attachment of the Study Reference Manual). 9. Subjects who have a history of chronic or recurrent inflammatory eye disease (e.g., iritis, scleritis, iridocyclitis, or rubeosis iridis) in either eye. 10. Subjects who have a visual disorder, other than cataracts, that could potentially cause future acuity losses to a level of 20/100 or worse in either eye. 11. Subjects who have had previous intraocular or corneal surgery in either eye, with the exception of laser trabeculoplasty. 12. Subjects with any preoperative infectious conjunctivitis, keratitis, or uveitis in either eye. 13. Subjects who have a preoperative corneal astigmatism \> 1.0 D in either eye, irregular astigmatism, or skewed radial axis (note: corneal incisions intended specifically to reduce astigmatism are not allowed during the study). 14. Subjects who cannot achieve a minimum pharmacologic pupil dilation of 5.0 mm in both eyes. 15. Subjects who may be expected to require a combined or other secondary surgical procedure in either eye. 16. Subjects who during the first cataract extraction experience an anterior or posterior capsule tear or rupture, zonular dialysis, significant iris trauma, or other complication that may cause untoward effects in the judgment of the Investigator. 17. Females of childbearing potential (those who are not surgically sterilized or at least 12 months postmenopausal) are excluded from enrollment in the study if they are currently pregnant or plan to become pregnant during the study. Females of childbearing potential must be willing to practice effective contraception for the duration of the study. 18. Subjects with any other serious ocular pathology or underlying systemic medical condition (e.g., uncontrolled diabetes) or circumstance that, based on the Investigator's judgment, poses a concern for the subjects' safety or could confound the results of the study. 19. Subjects who have current or previous usage of an alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha 1A adrenoceptor (e.g., Flomax® (tamsulosin HCl), Terazosin, or Cardura).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Photopic Monocular Best-corrected Distance Visual Acuity (BCDVA) | 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) |
| Photopic Monocular Distance-corrected Near Visual Acuity (DCNVA) | Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline. | 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) |
| Photopic Monocular Distance-corrected Intermediate Visual Acuity (DCIVA) | Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline. | 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 |
| Serious Adverse Events | Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline | All ocular SAEs, including secondary surgical interventions (SSIs) related to the optical properties of the IOL, in first eyes through study exit |
| The Rate of SSIs Due to the Optical Properties of the Lens for First Eyes Through Study Exit | Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline | 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. |
| The Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint | Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Photopic Binocular DCNVA at 40 cm at Postoperative Visit 4 | Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline. | 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) |
| Photopic Binocular UNVA at 40 cm at Postoperative Visit 4 | Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline. | Photopic binocular uncorrected near visual acuity (UNVA) at 40 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) |
| Photopic Binocular DCIVA at 66 cm at Postoperative Visit 4 | Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline. | 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) |
| Photopic Binocular UIVA at 66 cm at Postoperative Visit 4 | Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline. | Photopic binocular uncorrected intermediate visual acuity (UIVA) at 66 cm at Postoperative Visit 4 (Day 120 to Day 180 after second eye implantation) |
| First-eye BCDVA Evaluated at Postoperative Visit 5 | Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline | First-eye BCDVA evaluated at Postoperative Visit 5 (Day 330 to Day 420 after second eye implantation) |
| First-eye DCNVA Evaluated at Postoperative Visit 5 | Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline | First-eye DCNVA evaluated at Postoperative Visit 5 (Day 330 to Day 420 after second eye implantation) |
| First-eye DCIVA Evaluated at Postoperative Visit 5 | Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline | First-eye DCIVA evaluated at Postoperative Visit 5 (Day 330 to Day 420 after second eye implantation) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| enVista MX60EF enVista MX60EF (trifocal) multifocal IOL (MIOL)
enVista MX60EF: enVista MX60EF (trifocal) multifocal IOL (MIOL) | 332 |
| enVista MX60E enVista MX60E monofocal IOL
enVista MX60E: enVista MX60E monofocal IOL | 169 |
| Total | 501 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 1 |
| Overall Study | Lost to Follow-up | 2 | 3 |
| Overall Study | Other reason | 1 | 0 |
| Overall Study | Physician Decision | 2 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 7 |
Baseline characteristics
| Characteristic | enVista MX60EF | Total | enVista MX60E |
|---|---|---|---|
| Age, Continuous | 67.6 years STANDARD_DEVIATION 7.89 | 68.0 years STANDARD_DEVIATION 7.76 | 68.8 years STANDARD_DEVIATION 7.46 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 40 Participants | 60 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 292 Participants | 441 Participants | 149 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 15 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 23 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 305 Participants | 461 Participants | 156 Participants |
| Region of Enrollment United States | 322 participants | 501 participants | 169 participants |
| Sex: Female, Male Female | 212 Participants | 320 Participants | 108 Participants |
| Sex: Female, Male Male | 120 Participants | 181 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 332 | 1 / 169 |
| other Total, other adverse events | 120 / 332 | 47 / 169 |
| serious Total, serious adverse events | 17 / 332 | 15 / 169 |
Outcome results
Primary
Photopic Monocular Best-corrected Distance Visual Acuity (BCDVA)
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)
Time frame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| enVista MX60EF | Photopic Monocular Best-corrected Distance Visual Acuity (BCDVA) | 0.022 logMAR | Standard Deviation 0.095 |
| enVista MX60E | Photopic Monocular Best-corrected Distance Visual Acuity (BCDVA) | -0.017 logMAR | Standard Deviation 0.0897 |
Primary
Photopic Monocular Distance-corrected Intermediate Visual Acuity (DCIVA)
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
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| enVista MX60EF | Photopic Monocular Distance-corrected Intermediate Visual Acuity (DCIVA) | 0.122 logMAR | Standard Deviation 0.1199 |
| enVista MX60E | Photopic Monocular Distance-corrected Intermediate Visual Acuity (DCIVA) | 0.349 logMAR | Standard Deviation 0.1592 |
Primary
Photopic Monocular Distance-corrected Near Visual Acuity (DCNVA)
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)
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| enVista MX60EF | Photopic Monocular Distance-corrected Near Visual Acuity (DCNVA) | 0.152 logMAR | Standard Deviation 0.1342 |
| enVista MX60E | Photopic Monocular Distance-corrected Near Visual Acuity (DCNVA) | 0.545 logMAR | Standard Deviation 0.1703 |
Primary
Serious Adverse Events
All ocular SAEs, including secondary surgical interventions (SSIs) related to the optical properties of the IOL, in first eyes through study exit
Time frame: Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| enVista MX60EF | Serious Adverse Events | Ophthalmic herpes zoster | 0 Participants |
| enVista MX60EF | Serious Adverse Events | Macular hole | 1 Participants |
| enVista MX60EF | Serious Adverse Events | Retinal tear | 1 Participants |
| enVista MX60EF | Serious Adverse Events | Retinal vein occlusion | 1 Participants |
| enVista MX60EF | Serious Adverse Events | Seidel test positive | 1 Participants |
| enVista MX60E | Serious Adverse Events | Seidel test positive | 0 Participants |
| enVista MX60E | Serious Adverse Events | Retinal vein occlusion | 0 Participants |
| enVista MX60E | Serious Adverse Events | Macular hole | 0 Participants |
| enVista MX60E | Serious Adverse Events | Ophthalmic herpes zoster | 1 Participants |
| enVista MX60E | Serious Adverse Events | Retinal tear | 0 Participants |
Primary
The Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint
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
Time frame: Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Population: The measure was not assessed for the control arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| enVista MX60EF | The Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint | Cystoid macular oedema | 0 first eyes |
| enVista MX60EF | The Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint | Hypopyon | 0 first eyes |
| enVista MX60EF | The Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint | Endophthalmitis | 0 first eyes |
| enVista MX60EF | The Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint | Lens dislocated from posterior chamber | 0 first eyes |
| enVista MX60EF | The Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint | Pupillary block | 0 first eyes |
| enVista MX60EF | The Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint | Retinal detachment | 0 first eyes |
| enVista MX60EF | The Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint | SSI | 0 first eyes |
Primary
The Rate of SSIs Due to the Optical Properties of the Lens for First Eyes Through Study Exit
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.
Time frame: Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| enVista MX60EF | The Rate of SSIs Due to the Optical Properties of the Lens for First Eyes Through Study Exit | 0 first eyes |
| enVista MX60E | The Rate of SSIs Due to the Optical Properties of the Lens for First Eyes Through Study Exit | 0 first eyes |
Secondary
First-eye BCDVA Evaluated at Postoperative Visit 5
First-eye BCDVA evaluated at Postoperative Visit 5 (Day 330 to Day 420 after second eye implantation)
Time frame: Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline
Population: Modified Intent to Treat Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| enVista MX60EF | First-eye BCDVA Evaluated at Postoperative Visit 5 | 0.027 logMAR | Standard Deviation 0.092 |
| enVista MX60E | First-eye BCDVA Evaluated at Postoperative Visit 5 | -0.020 logMAR | Standard Deviation 0.0826 |
Secondary
First-eye DCIVA Evaluated at Postoperative Visit 5
First-eye DCIVA evaluated at Postoperative Visit 5 (Day 330 to Day 420 after second eye implantation)
Time frame: Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline
Population: Modified Intent to Treat Set Excluding Phase I Subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| enVista MX60EF | First-eye DCIVA Evaluated at Postoperative Visit 5 | 0.120 logMAR | Standard Deviation 0.1147 |
| enVista MX60E | First-eye DCIVA Evaluated at Postoperative Visit 5 | 0.343 logMAR | Standard Deviation 0.1594 |
Secondary
First-eye DCNVA Evaluated at Postoperative Visit 5
First-eye DCNVA evaluated at Postoperative Visit 5 (Day 330 to Day 420 after second eye implantation)
Time frame: Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline
Population: Modified Intent to Treat Set Excluding Phase I Subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| enVista MX60EF | First-eye DCNVA Evaluated at Postoperative Visit 5 | 0.143 logMAR | Standard Deviation 0.1284 |
| enVista MX60E | First-eye DCNVA Evaluated at Postoperative Visit 5 | 0.533 logMAR | Standard Deviation 0.1843 |
Secondary
Photopic Binocular DCIVA at 66 cm at Postoperative Visit 4
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)
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| enVista MX60EF | Photopic Binocular DCIVA at 66 cm at Postoperative Visit 4 | 0.041 logMAR | Standard Deviation 0.0976 |
| enVista MX60E | Photopic Binocular DCIVA at 66 cm at Postoperative Visit 4 | 0.268 logMAR | Standard Deviation 0.1485 |
Secondary
Photopic Binocular DCNVA at 40 cm at Postoperative Visit 4
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)
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| enVista MX60EF | Photopic Binocular DCNVA at 40 cm at Postoperative Visit 4 | 0.080 logMAR | Standard Deviation 0.0977 |
| enVista MX60E | Photopic Binocular DCNVA at 40 cm at Postoperative Visit 4 | 0.453 logMAR | Standard Deviation 0.1526 |
Secondary
Photopic Binocular UIVA at 66 cm at Postoperative Visit 4
Photopic binocular uncorrected intermediate visual acuity (UIVA) at 66 cm at Postoperative Visit 4 (Day 120 to Day 180 after second eye implantation)
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| enVista MX60EF | Photopic Binocular UIVA at 66 cm at Postoperative Visit 4 | 0.064 logMAR | Standard Deviation 0.0988 |
| enVista MX60E | Photopic Binocular UIVA at 66 cm at Postoperative Visit 4 | 0.217 logMAR | Standard Deviation 0.1442 |
Secondary
Photopic Binocular UNVA at 40 cm at Postoperative Visit 4
Photopic binocular uncorrected near visual acuity (UNVA) at 40 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| enVista MX60EF | Photopic Binocular UNVA at 40 cm at Postoperative Visit 4 | 0.096 logMAR | Standard Deviation 0.1056 |
| enVista MX60E | Photopic Binocular UNVA at 40 cm at Postoperative Visit 4 | 0.418 logMAR | Standard Deviation 0.1454 |