Aphakia, Cataract
Conditions
Keywords
Cataracts, Phacoemulsification, IOL
Brief summary
The primary purpose of this study is to compare the Clareon/Clareon Toric Intraocular Lenses (IOLs) to the Eyhance/Eyhance Toric IOLs in binocular Best Corrected Distance Visual Acuity (BCDVA) at 3 months postoperative.
Detailed description
This study will enroll adults 22 years of age and older diagnosed with cataracts in both eyes with planned bilateral cataract removal by routine small incision phacoemulsification surgery. Subjects will attend up to 7 scheduled visits: A screening visit, two operative visits, and four post-operative visits. The expected individual duration of participation in the study is 3 months.
Interventions
DEVICEClareon IOL
Alcon Clareon Aspheric Hydrophobic Acrylic IOL for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. The lens is indicated for primary implantation in the capsular bag in the posterior chamber of the eye, replacing the natural crystalline lens. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject.
DEVICEClareon Toric IOL
Clareon Toric Aspheric Hydrophobic Acrylic Toric IOL for the visual correction of aphakia with pre-existing corneal astigmatism in adult patients in whom a cataractous lens has been removed. The lens is indicated for primary implantation in the capsular bag in the posterior chamber of the eye, replacing the natural crystalline lens. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject.
DEVICEEyhance IOL
TECNIS Eyhance IOL with TECNIS Simplicity Delivery System for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject.
DEVICEEyhance Toric IOL
TECNIS Eyhance Toric II IOL with TECNIS Simplicity Delivery System for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire reduction in residual refractive cylinder. The lens is intended to be placed in the capsular bag. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject.
PROCEDUREPhacoemulsification surgery
Cataract removal by routine small incision phacoemulsification surgery
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Planned bilateral cataract removal by routine small incision phacoemulsification surgery; * Planned implantation of either test or comparator IOL (per randomization) in at least one eye with approximately 1.00 - 3.00 diopter (D) of preoperative corneal astigmatism; * Predicted postoperative astigmatism of ≤ 0.5 D in both operative eyes based on a Toric calculator; * Other protocol-specified inclusion criteria may apply. Key
Exclusion criteria
* Any disease or pathology, other than cataract, that (in the investigator's opinion) may reduce potential Best Corrected Distance Visual Acuity (BCDVA) to a level worse than 0.2 logarithm minimum angle of resolution (logMAR); * Clinically significant (in the investigator's opinion) corneal pathology, dry-eye or ocular surface disease that would adversely affect a) the biometry measures and/or toric calculations and b) the visual outcome; * History of previous intraocular or corneal surgery (including laser-assisted in situ keratomileusis (LASIK)); * Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI), astigmatic keratotomy, LASIK, and retinal laser treatment within the study time frame; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Binocular Best-corrected Distance Visual Acuity (BCDVA) at 4 Meters Under Bright Lighting Conditions | Month 3 postoperative visit | Visual acuity was tested at a distance of 4 meters using a refraction chart and the correction obtained from a manifest refraction. BCDVA was measured in logarithm minimum angle of resolution (logMAR) units, with 0.00 logMar equating to 20/20 Snellen, which is considered normal distance eyesight. A lower logMAR value (more negative value) indicates better eyesight. This was a subject based assessment, and subject assigned a single score for both eyes. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 8 investigative sites located in the United States.
Pre-assignment details
Of the 203 enrolled, 14 subjects were exited prior to randomization as screen failures, and 14 subjects were discontinued after randomization and prior to attempted implantation. This reporting group includes all subjects with attempted implantation per actual treatment (175).
Participants by arm
| Arm | Count |
|---|---|
| Clareon/Clareon Toric Phacoemulsification surgery, followed by implantation with Alcon Clareon Aspheric Hydrophobic Acrylic IOL or Alcon Clareon Aspheric Hydrophobic Acrylic Toric IOL, as indicated. The second eye surgery was recommended to occur within 14 days after the 1st eye surgery. | 89 |
| Eyhance/Eyhance Toric Phacoemulsification surgery, followed by implantation with TECNIS Eyhance IOL or TECNIS Eyhance Toric II IOL, as indicated. The second eye surgery was recommended to occur within 14 days after the 1st eye surgery. | 86 |
| Total | 175 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Clareon/Clareon Toric | Eyhance/Eyhance Toric |
|---|---|---|---|
| Age, Continuous | 69.7 years STANDARD_DEVIATION 7.69 | 69.0 years STANDARD_DEVIATION 7.63 | 70.4 years STANDARD_DEVIATION 7.73 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants | 11 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 151 Participants | 77 Participants | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 24 Participants | 15 Participants | 9 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 6 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 144 Participants | 70 Participants | 74 Participants |
| Region of Enrollment United States | 175 participants | 89 participants | 86 participants |
| Sex: Female, Male Female | 101 Participants | 47 Participants | 54 Participants |
| Sex: Female, Male Male | 74 Participants | 42 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 175 | 0 / 89 | 0 / 86 | 0 / 89 | 0 / 86 | 0 / 84 | 0 / 86 |
| other Total, other adverse events | 0 / 175 | 11 / 89 | 8 / 86 | 0 / 89 | 6 / 86 | 7 / 84 | 0 / 86 |
| serious Total, serious adverse events | 0 / 175 | 2 / 89 | 0 / 86 | 2 / 89 | 2 / 86 | 0 / 84 | 3 / 86 |
Outcome results
Primary
Mean Binocular Best-corrected Distance Visual Acuity (BCDVA) at 4 Meters Under Bright Lighting Conditions
Visual acuity was tested at a distance of 4 meters using a refraction chart and the correction obtained from a manifest refraction. BCDVA was measured in logarithm minimum angle of resolution (logMAR) units, with 0.00 logMar equating to 20/20 Snellen, which is considered normal distance eyesight. A lower logMAR value (more negative value) indicates better eyesight. This was a subject based assessment, and subject assigned a single score for both eyes.
Time frame: Month 3 postoperative visit
Population: AAS with data at visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clareon/Clareon Toric | Mean Binocular Best-corrected Distance Visual Acuity (BCDVA) at 4 Meters Under Bright Lighting Conditions | -0.100 logMAR | Standard Deviation 0.088 |
| Eyhance/Eyhance Toric | Mean Binocular Best-corrected Distance Visual Acuity (BCDVA) at 4 Meters Under Bright Lighting Conditions | -0.055 logMAR | Standard Deviation 0.0716 |