Cataract
Conditions
Keywords
Monofocal IOL, Clareon
Brief summary
The objective is to evaluate refractive stability (spherical equivalent change ≤ 0.50D from 1-month to 3-months).
Detailed description
This study is a single-arm, evaluator masked clinical evaluation study of refractive stability, after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 month and 3 months post-operatively. Clinical evaluations will include measurement of bilateral visual acuity, manifest refraction, and defocus curve.
Interventions
DEVICEClareon
Clareon monofocal intraocular lens (IOL)
Sponsors
Sengi
Gainesville Eye Associates
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Inclusion criteria
Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes. * Presenting for uncomplicated bilateral cataract surgery and have an interest in an IOL option * Gender: Males and Females. * Age: 50 or older * Willing and able to provide written informed consent for participation in the study * Willing and able to comply with scheduled visits and other study procedures. * Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract) * Potential postoperative visual acuity of (20/25 Snellen) or better in both eyes
Exclusion criteria
If any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Refractive Stability | 3 months | Refractive stability (spherical equivalent change ≤ 0.50D from 1-month to 3-months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Uncorrected Distance Visual Acuity | 3 months | Binocular uncorrected distance visual acuity in logMAR |
| Binocular Uncorrected Intermediate Visual Acuity | 3 months | Binocular uncorrected intermediate visual acuity in logMAR |
| Binocular Corrected Distance Visual Acuity | 3 months | Binocular corrected distance visual acuity in logMAR |
| Binocular Distance-corrected Intermediate Visual Acuity | 3 months | Binocular distance-corrected intermediate visual acuity in logMAR |
| Binocular Defocus Curve | 3 months | A binocular defocus curve is obtained by measuring visual acuity (logMAR) at different spherical powers (D). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bilateral Implantation of the Clareon Monofocal IOL Clareon monofocal intraocular lens (IOL)
Clareon: Clareon monofocal intraocular lens (IOL) | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | Bilateral Implantation of the Clareon Monofocal IOL | — |
|---|---|---|
| Age, Continuous | 72.1 years STANDARD_DEVIATION 5.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 13 Participants | — |
| Sex: Female, Male Male | 16 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 31 |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
Primary
Refractive Stability
Refractive stability (spherical equivalent change ≤ 0.50D from 1-month to 3-months)
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bilateral Implantation of the Clareon Monofocal IOL | Refractive Stability | 0.03 Diopters (D) |
Secondary
Binocular Corrected Distance Visual Acuity
Binocular corrected distance visual acuity in logMAR
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral Implantation of the Clareon Monofocal IOL | Binocular Corrected Distance Visual Acuity | -0.04 logMAR | Standard Deviation 0.06 |
Secondary
Binocular Defocus Curve
A binocular defocus curve is obtained by measuring visual acuity (logMAR) at different spherical powers (D).
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bilateral Implantation of the Clareon Monofocal IOL | Binocular Defocus Curve | -1.0 D | 0.20 logMAR | Standard Deviation 0.12 |
| Bilateral Implantation of the Clareon Monofocal IOL | Binocular Defocus Curve | -0.5 D | 0.06 logMAR | Standard Deviation 0.11 |
| Bilateral Implantation of the Clareon Monofocal IOL | Binocular Defocus Curve | 0.0 D | -0.01 logMAR | Standard Deviation 0.11 |
| Bilateral Implantation of the Clareon Monofocal IOL | Binocular Defocus Curve | 0.5 D | 0.08 logMAR | Standard Deviation 0.09 |
| Bilateral Implantation of the Clareon Monofocal IOL | Binocular Defocus Curve | -4.0 D | 0.90 logMAR | Standard Deviation 0.13 |
| Bilateral Implantation of the Clareon Monofocal IOL | Binocular Defocus Curve | -3.5 D | 0.84 logMAR | Standard Deviation 0.14 |
| Bilateral Implantation of the Clareon Monofocal IOL | Binocular Defocus Curve | -3.0 D | 0.73 logMAR | Standard Deviation 0.16 |
| Bilateral Implantation of the Clareon Monofocal IOL | Binocular Defocus Curve | -2.5 D | 0.64 logMAR | Standard Deviation 0.16 |
| Bilateral Implantation of the Clareon Monofocal IOL | Binocular Defocus Curve | -2.0 D | 0.49 logMAR | Standard Deviation 0.16 |
| Bilateral Implantation of the Clareon Monofocal IOL | Binocular Defocus Curve | -1.5 D | 0.34 logMAR | Standard Deviation 0.12 |
| Bilateral Implantation of the Clareon Monofocal IOL | Binocular Defocus Curve | 1.0 D | 0.25 logMAR | Standard Deviation 0.12 |
Secondary
Binocular Distance-corrected Intermediate Visual Acuity
Binocular distance-corrected intermediate visual acuity in logMAR
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral Implantation of the Clareon Monofocal IOL | Binocular Distance-corrected Intermediate Visual Acuity | 0.16 logMAR | Standard Deviation 0.13 |
Secondary
Binocular Uncorrected Distance Visual Acuity
Binocular uncorrected distance visual acuity in logMAR
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral Implantation of the Clareon Monofocal IOL | Binocular Uncorrected Distance Visual Acuity | -0.01 logMAR | Standard Deviation 0.1 |
Secondary
Binocular Uncorrected Intermediate Visual Acuity
Binocular uncorrected intermediate visual acuity in logMAR
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral Implantation of the Clareon Monofocal IOL | Binocular Uncorrected Intermediate Visual Acuity | 0.16 logMAR | Standard Deviation 0.13 |