Aphakia, Presbyopia
Conditions
Keywords
Cataract, IOL
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of Clareon™ PanOptix™ Pro Trifocal Intraocular Lens (IOL) compared to Clareon™ PanOptix™ Trifocal IOL.
Detailed description
Subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 6 months. The primary endpoint will be assessed at the Month 2 follow-up visit. Both eyes of a subject must qualify for enrollment into this study.
Interventions
DEVICECPO Pro IOL
Intraocular lens (IOL) implanted in the eye for the visual correction of aphakia in adult patients with less than 1 diopter of preexisting corneal astigmatism in whom a cataractous lens has been removed. The IOL is intended to mitigate the effects of presbyopia on intermediate and near visual acuity while maintaining comparable distance visual acuity.
DEVICECPO IOL
Intraocular lens (IOL) implanted in the eye for the visual correction of aphakia in adult patients with less than 1 diopter of preexisting corneal astigmatism in whom a cataractous lens has been removed. The IOL is intended to mitigate the effects of presbyopia on intermediate and near visual acuity while maintaining distance visual acuity.
PROCEDURECataract surgery
Extraction of the cataractous lens by phacoemulsification, followed by implantation of the IOL.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Contralateral (split face) study design
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Understand and sign an ethics committee-approved informed consent form; * Willing and able to attend all scheduled study visits as required by the protocol; * Planned cataract surgery (both eyes); * Preoperative corneal astigmatism less that 1.00 diopter in each eye. * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Women of childbearing potential if currently pregnant, intend to become pregnant during the study, or are breastfeeding; * Ocular conditions as specified in the protocol; * Subjects who desire monovision correction. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) | Month 2 postoperative | Visual Acuity (VA) was assessed for each eye individually using Early Treatment Diabetic Retinopathy Study (ETDRS) reading charts at a distance of 4 meters from the subject under photopic (well-lit) conditions with correction in place. BCDVA was measured in logarithm Minimum Angle of Resolution (logMAR). LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision), with lower scores indicating better vision. |
Countries
United States
Participant flow
Pre-assignment details
Of the 87 randomized participants, 4 were discontinued after randomization and prior to attempted implantation. This reporting group includes all participants with attempted implantation (83).
Participants by arm
| Arm | Count |
|---|---|
| CPO Pro IOL / CPO IOL CPO Pro IOL Model PXYWT0 implanted in one eye with CPO IOL Model CNWTT0 implanted in the other eye, as randomized. The second eye surgery occurred approximately 7-14 days after the first eye surgery. | 83 |
| Total | 83 |
Baseline characteristics
| Characteristic | CPO Pro IOL / CPO IOL |
|---|---|
| Age, Continuous | 68.4 years STANDARD_DEVIATION 7.15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 73 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 12 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 64 Participants |
| Region of Enrollment United States | 83 participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 83 | 0 / 0 | 0 / 0 | 0 / 83 |
| other Total, other adverse events | 0 / 83 | 6 / 83 | 8 / 83 | 0 / 83 |
| serious Total, serious adverse events | 0 / 83 | 1 / 83 | 3 / 83 | 2 / 83 |
Outcome results
Primary
Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA)
Visual Acuity (VA) was assessed for each eye individually using Early Treatment Diabetic Retinopathy Study (ETDRS) reading charts at a distance of 4 meters from the subject under photopic (well-lit) conditions with correction in place. BCDVA was measured in logarithm Minimum Angle of Resolution (logMAR). LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision), with lower scores indicating better vision.
Time frame: Month 2 postoperative
Population: All-Implanted Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CPO Pro IOL | Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) | 0.032 logMAR | Standard Deviation 0.0919 |
| CPO IOL | Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) | 0.023 logMAR | Standard Deviation 0.0813 |
t-test, 1 sided