Cataract
Conditions
Brief summary
The objective of this study is to compare visual acuity and adverse event outcomes from the Clareon intraocular lens (IOL) to historical safety and performance endpoint (SPE) rates.
Detailed description
Upon meeting eligibility criteria, subjects were implanted unilaterally (in one eye) with a Clareon IOL. Subjects attended 7 study visits over a period of approximately 13 months, including 1 preoperative screening visit (Visit 0), 1 operative visit (Visit 00), and 5 postoperative visits (Visits 1-5). Visit day calculations for Visits 1-5 were based off of the day of surgery (Visit 00). Primary endpoint data was collected at the final visit (Month 12). Some sites/subjects participated in a Rotational Stability sub-study. For the non-study eye, the investigator followed standard of care regarding the follow-up, surgery, and intraocular lens choice (as applicable). The non-study eye (fellow eye) was not implanted with the Clareon IOL.
Interventions
DEVICEClareon aspheric hydrophobic acrylic monofocal IOL
Ultraviolet-absorbing and blue light-filtering IOL composed of high refractive-index foldable and flexible acrylic material. IOLs are implantable medical devices intended for long term use over the lifetime of the cataract subject.
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: * Planned routine cataract surgery in at least one eye; * Calculated lens power within the available range; * Willing and able to sign an informed consent statement; * Clear intraocular media other than cataract. Key
Exclusion criteria
* Any disease or pathology, other than cataract, that is expected to reduce the potential postoperative best corrected distance visual acuity (BCDVA) to a level worse than 0.30 logMAR; * Previous corneal surgery; * Rubella or traumatic cataract; * Ocular trauma, previous refractive surgery; * Current or recent use of certain medications as specified in the protocol; * Any other ocular or systemic condition that, in the opinion of the Investigator, should exclude the subject from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of All-implanted Subjects Achieving Monocular Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logMAR or Better at Month 12 Postoperative | Month 12 (postoperative) | Visual acuity (VA) of the study eye was assessed with best refractive correction in place under photopic (well-lit) conditions at a distance of 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. As pre-specified in the protocol, the percentage of subjects with monocular BCDVA of 0.3 logMAR or better at Month 12 was compared to the historical safety and performance endpoint (SPE) rate reported in EN ISO 11979-7:2014. A higher percentage indicates good visual acuity outcomes with most subjects achieving 0.3 logMAR or better. |
| Percentage of Best-case Subjects Achieving Monocular BCDVA of 0.3 logMAR or Better at Month 12 Postoperative | Month 12 (postoperative) | Visual acuity (VA) of the study eye was assessed with best refractive correction in place under photopic conditions at a distance of 4 meters using an Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. As pre-specified in the protocol, the percentage of subjects with monocular BCDVA of 0.3 logMAR or better at Month 12 was compared to the historical safety and performance endpoint (SPE) rate reported in EN ISO 11979-7:2014. A higher percentage indicates good visual acuity outcomes with most subjects achieving 0.3 logMAR or better. |
| Percentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye | Day 0 (operative), up to Month 12 (postoperative) | Adverse events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. No hypothesis testing was pre-specified in the protocol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Absolute IOL Misplacement | Day 0 (operative) | IOL misplacement was defined as the difference between intended axis of placement and actual axis of IOL orientation on day of surgery. IOL misplacement was measured using slit lamp photography. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL misplacement. |
| Mean Absolute IOL Rotation | Day 0 (operative), Month 6 (postoperative) | IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and Month 6. IOL rotation and measured with slit-lamp photography. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL rotation at 6 months. |
| Mean Absolute IOL Misalignment | Day 0 (operative), Month 6 (postoperative) | IOL misalignment was defined as the summation of IOL misplacement and IOL rotation at Month 6. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL misalignment at 6 months. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited at 16 investigative sites located in the United States.
Pre-assignment details
Of the 376 enrolled, 26 subjects did exit the study as screen failures. This reporting group (350) includes all subjects with attempted implantation with the IOL (successful or aborted after contact with the eye).
Participants by arm
| Arm | Count |
|---|---|
| Clareon IOL Clareon aspheric hydrophobic acrylic monofocal intraocular lens (IOL) implanted in one eye during routine small incision cataract surgery | 350 |
| Total | 350 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Clareon IOL |
|---|---|
| Age, Continuous | 69.7 years STANDARD_DEVIATION 6.44 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 336 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 29 Participants |
| Race (NIH/OMB) Black or African American | 36 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) White | 273 Participants |
| Region of Enrollment United States | 350 participants |
| Sex: Female, Male Female | 213 Participants |
| Sex: Female, Male Male | 137 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 350 | 0 / 350 | 2 / 350 |
| other Total, other adverse events | 6 / 350 | 19 / 350 | 127 / 350 |
| serious Total, serious adverse events | 0 / 350 | 8 / 350 | 18 / 350 |
Outcome results
Primary
Percentage of All-implanted Subjects Achieving Monocular Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logMAR or Better at Month 12 Postoperative
Visual acuity (VA) of the study eye was assessed with best refractive correction in place under photopic (well-lit) conditions at a distance of 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. As pre-specified in the protocol, the percentage of subjects with monocular BCDVA of 0.3 logMAR or better at Month 12 was compared to the historical safety and performance endpoint (SPE) rate reported in EN ISO 11979-7:2014. A higher percentage indicates good visual acuity outcomes with most subjects achieving 0.3 logMAR or better.
Time frame: Month 12 (postoperative)
Population: All-Implanted Subjects (AAS): All subjects/eyes with successful IOL implantation and data at visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clareon IOL | Percentage of All-implanted Subjects Achieving Monocular Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logMAR or Better at Month 12 Postoperative | 99.7 percentage of subjects |
Primary
Percentage of Best-case Subjects Achieving Monocular BCDVA of 0.3 logMAR or Better at Month 12 Postoperative
Visual acuity (VA) of the study eye was assessed with best refractive correction in place under photopic conditions at a distance of 4 meters using an Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. As pre-specified in the protocol, the percentage of subjects with monocular BCDVA of 0.3 logMAR or better at Month 12 was compared to the historical safety and performance endpoint (SPE) rate reported in EN ISO 11979-7:2014. A higher percentage indicates good visual acuity outcomes with most subjects achieving 0.3 logMAR or better.
Time frame: Month 12 (postoperative)
Population: Best-Case Analysis Set (BAS): All subjects/eyes successfully implanted with the IOL that had at least 1 postoperative visit, no preoperative ocular pathology, no macular degeneration at any time, and no previous surgery for the correction of refractive errors, with data at visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clareon IOL | Percentage of Best-case Subjects Achieving Monocular BCDVA of 0.3 logMAR or Better at Month 12 Postoperative | 99.7 percentage of subjects |
Primary
Percentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye
Adverse events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. No hypothesis testing was pre-specified in the protocol.
Time frame: Day 0 (operative), up to Month 12 (postoperative)
Population: Safety Analysis Set (SAS): All subjects/study eyes with attempted implantation with the test article (successful or aborted after contact with the eye)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clareon IOL | Percentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye | Serious Adverse Events | 0 percentage of subjects |
| Clareon IOL | Percentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye | Non-Serious Adverse Events | 1.4 percentage of subjects |
| Clareon IOL - Ocular | Percentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye | Serious Adverse Events | 2.3 percentage of subjects |
| Clareon IOL - Ocular | Percentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye | Non-Serious Adverse Events | 27.1 percentage of subjects |
| Systemic | Percentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye | Serious Adverse Events | 4.0 percentage of subjects |
| Systemic | Percentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye | Non-Serious Adverse Events | 15.1 percentage of subjects |
Secondary
Mean Absolute IOL Misalignment
IOL misalignment was defined as the summation of IOL misplacement and IOL rotation at Month 6. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL misalignment at 6 months.
Time frame: Day 0 (operative), Month 6 (postoperative)
Population: RAS, with rotation data available at operative visit and Month 6 visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clareon IOL | Mean Absolute IOL Misalignment | 5.6762 degrees | Standard Deviation 6.4251 |
Secondary
Mean Absolute IOL Misplacement
IOL misplacement was defined as the difference between intended axis of placement and actual axis of IOL orientation on day of surgery. IOL misplacement was measured using slit lamp photography. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL misplacement.
Time frame: Day 0 (operative)
Population: RAS: All subjects/eyes with successful IOL implantation from the rotational subset of 6 clinical sites, with rotation data available at operative visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clareon IOL | Mean Absolute IOL Misplacement | 5.1163 degrees | Standard Deviation 4.90305 |
Secondary
Mean Absolute IOL Rotation
IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and Month 6. IOL rotation and measured with slit-lamp photography. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL rotation at 6 months.
Time frame: Day 0 (operative), Month 6 (postoperative)
Population: Rotation Analysis Set (RAS): All subjects/eyes with successful IOL implantation from the rotational subset of 6 clinical sites, with rotation data available at operative visit and Month 6 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clareon IOL | Mean Absolute IOL Rotation | 2.2696 degrees | Standard Deviation 3.87231 |