Aphakia, Cataract
Conditions
Brief summary
The primary purpose of this study is to evaluate the long-term (3 years) visual acuity and adverse event outcomes for the Clareon® Intraocular Lens (IOL). A comparison to historical safety and performance endpoint (SPE) rates as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014 will be conducted at one year. The secondary purpose of this study is to evaluate the visual acuity outcomes with the Clareon IOL at Years 2 and 3.
Detailed description
Subjects will attend a total of 12 study visits over a period of approximately 36 months: One preoperative screening visit, two operative visits, and nine post-implantation visits. Both eyes will be implanted, with the second eye implantation to occur 2-21 days after the first. Primary endpoint data will be collected at the Year 1 visit (Day 330-420 post-implantation from second eye surgery).
Interventions
DEVICEClareon® IOL
Foldable, single-piece posterior chamber IOL intended for long-term use over the lifetime of the cataract patient. This device is CE-marked (European Conformity) in the countries with participating Investigators.
PROCEDURECataract Surgery
Routine small incision cataract surgery with unilateral IOL implantation
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Diagnosed with bilateral cataracts * Planned small incision cataract removal surgery * Able to comprehend and willing to sign a statement of informed consent and complete all required post-implantation visits Key
Exclusion criteria
* Subjects who may reasonably be expected to require ocular surgical treatment or refractive surgical procedures at any time during the study * Certain eye conditions, as specified in the protocol, including but not limited to glaucoma, diabetic retinopathy, diabetic macular edema, and macular degeneration * Pregnant or lactating, current or planned during the course of the study Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of First Implanted Eyes Achieving Best-Corrected Distance Visual Acuity (BCDVA) of 0.3 Logarithm Minimum Angle of Resolution (logMAR) or Better at 1 Year Post-Implantation | Year 1 post-implantation from second eye surgery | Visual acuity (VA) was tested for the first implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. VA was compared to the historical safety and performance endpoint (SPE) of 92.5% \[as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014\]. |
| Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 1 Year Post-Implantation | Year 1 post-implantation from second eye surgery | VA was tested for the second implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. VA was compared to the historical SPE of 92.5% (EN ISO 11979-7:2014). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation | Year 3 post-implantation from second eye surgery | VA was tested for the first implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint. |
| Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation | Year 3 post-implantation from second eye surgery | VA was tested for the second implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint. |
| Uncorrected Distance Visual Acuity (UCDVA) at 1 Year Post-Implantation - First Implanted Eye | Year 1 post-implantation from second eye surgery | VA was tested for the first implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 diopter (D) spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint. |
| UCDVA at 1 Year Post-Implantation - Second Implanted Eye | Year 1 post-implantation from second eye surgery | VA was tested for the second implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint. |
| Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation | Year 2 post-implantation from second eye surgery | VA was tested for the first implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint. |
| UCDVA at 2 Years Post-Implantation - Second Implanted Eye | Year 2 post-implantation from second eye surgery | VA was tested for the second implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint. |
| UCDVA at 3 Years Post-Implantation - First Implanted Eye | Year 3 post-implantation from second eye surgery | VA was tested for the first implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint. |
| UCDVA at 3 Years Post-Implantation - Second Implanted Eye | Year 3 post-implantation from second eye surgery | VA was tested for the second implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint. |
| UCDVA at 2 Years Post-Implantation - First Implanted Eye | Year 2 post-implantation from second eye surgery | VA was tested for the first implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint. |
| Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation | Year 2 post-implantation from second eye surgery | VA was tested for the second implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint. |
Countries
Australia, France, Germany, Italy, Netherlands, Spain, United Kingdom
Participant flow
Recruitment details
Study participants were recruited from 19 study centers located in Australia (n = 3), France (n = 2), Germany (n = 2), Italy (n = 2), the Netherlands (n = 2), Spain (n = 5), and the United Kingdom (n = 3).
Pre-assignment details
Of the 245 enrolled, 30 participants were discontinued from the study prior to attempted implantation with the IOL. This reporting group includes all participants with attempted implantation (215).
Participants by arm
| Arm | Count |
|---|---|
| Clareon IOL Clareon® aspheric hydrophobic acrylic intraocular lens implanted with the Alcon Monarch III-D delivery system as a replacement of the human crystalline lens during cataract surgery | 215 |
| Total | 215 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | COVID related | 8 |
| Overall Study | Death | 10 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Clareon IOL |
|---|---|
| Age, Continuous | 72.1 years STANDARD_DEVIATION 8.07 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 195 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 204 Participants |
| Sex: Female, Male Female | 126 Participants |
| Sex: Female, Male Male | 89 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 / 215 | 0 / 215 | 0 / 209 | 10 / 215 |
| other Total, other adverse events | 0 / 215 | 34 / 215 | 39 / 209 | 0 / 215 |
| serious Total, serious adverse events | 0 / 215 | 6 / 215 | 4 / 209 | 31 / 215 |
Outcome results
Primary
Percentage of First Implanted Eyes Achieving Best-Corrected Distance Visual Acuity (BCDVA) of 0.3 Logarithm Minimum Angle of Resolution (logMAR) or Better at 1 Year Post-Implantation
Visual acuity (VA) was tested for the first implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. VA was compared to the historical safety and performance endpoint (SPE) of 92.5% \[as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014\].
Time frame: Year 1 post-implantation from second eye surgery
Population: All Implanted Analysis Set with data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clareon IOL | Percentage of First Implanted Eyes Achieving Best-Corrected Distance Visual Acuity (BCDVA) of 0.3 Logarithm Minimum Angle of Resolution (logMAR) or Better at 1 Year Post-Implantation | 99.5 percentage of first implanted eyes |
Primary
Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 1 Year Post-Implantation
VA was tested for the second implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. VA was compared to the historical SPE of 92.5% (EN ISO 11979-7:2014).
Time frame: Year 1 post-implantation from second eye surgery
Population: All Implanted Analysis Set with data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clareon IOL | Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 1 Year Post-Implantation | 99.5 percentage of second implanted eyes |
Secondary
Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation
VA was tested for the first implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 2 post-implantation from second eye surgery
Population: All Implanted Analysis Set with data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clareon IOL | Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation | 99.5 percentage of second implanted eyes |
Secondary
Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation
VA was tested for the first implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 3 post-implantation from second eye surgery
Population: All Implanted Analysis Set with data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clareon IOL | Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation | 99.5 percentage of first implanted eyes |
Secondary
Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation
VA was tested for the second implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 2 post-implantation from second eye surgery
Population: All Implanted Analysis Set with data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clareon IOL | Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation | 98.9 percentage of second implanted eyes |
Secondary
Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation
VA was tested for the second implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 3 post-implantation from second eye surgery
Population: All Implanted Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clareon IOL | Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation | 98.9 percentage of second implanted eyes |
Secondary
UCDVA at 1 Year Post-Implantation - Second Implanted Eye
VA was tested for the second implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 1 post-implantation from second eye surgery
Population: All Implanted Analysis Set with data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clareon IOL | UCDVA at 1 Year Post-Implantation - Second Implanted Eye | 0.058 logMAR | Standard Deviation 0.1364 |
Secondary
UCDVA at 2 Years Post-Implantation - First Implanted Eye
VA was tested for the first implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 2 post-implantation from second eye surgery
Population: All Implanted Analysis Set with data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clareon IOL | UCDVA at 2 Years Post-Implantation - First Implanted Eye | 0.088 logMAR | Standard Deviation 0.1533 |
Secondary
UCDVA at 2 Years Post-Implantation - Second Implanted Eye
VA was tested for the second implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 2 post-implantation from second eye surgery
Population: All Implanted Analysis Set with data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clareon IOL | UCDVA at 2 Years Post-Implantation - Second Implanted Eye | 0.083 logMAR | Standard Deviation 0.1624 |
Secondary
UCDVA at 3 Years Post-Implantation - First Implanted Eye
VA was tested for the first implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 3 post-implantation from second eye surgery
Population: All Implanted Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clareon IOL | UCDVA at 3 Years Post-Implantation - First Implanted Eye | 0.091 logMAR | Standard Deviation 0.1614 |
Secondary
UCDVA at 3 Years Post-Implantation - Second Implanted Eye
VA was tested for the second implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 3 post-implantation from second eye surgery
Population: All Implanted Analysis Set with data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clareon IOL | UCDVA at 3 Years Post-Implantation - Second Implanted Eye | 0.086 logMAR | Standard Deviation 0.1706 |
Secondary
Uncorrected Distance Visual Acuity (UCDVA) at 1 Year Post-Implantation - First Implanted Eye
VA was tested for the first implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 diopter (D) spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 1 post-implantation from second eye surgery
Population: All Implanted Analysis Set with data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clareon IOL | Uncorrected Distance Visual Acuity (UCDVA) at 1 Year Post-Implantation - First Implanted Eye | 0.079 logMAR | Standard Deviation 0.1499 |