Astigmatism, Cataract
Conditions
Brief summary
The objective of this clinical trial is to evaluate the safety and effectiveness of the Bausch + Lomb Toric Accommodating Posterior Chamber Silicone Intraocular Lens used to provide near, intermediate, and distance vision and a reduction of the effects of preoperative corneal astigmatism in presbyopic patients undergoing cataract extraction and intraocular lens (IOL) placement.
Interventions
DEVICEToric Accommodating Lens
Toric accommodating lens implanted after cataract extraction
DEVICEAccommodating Lens
Accommodating lens implanted after cataract extraction
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have a clinically documented diagnosis of age-related cataract * Subjects must require a lens power from 16 to 27 diopters * Subjects must have predicted post-operative corneal astigmatism between 0.83D and 2.50D, as determined by the Toric Calculator
Exclusion criteria
* Subjects with any anterior segment pathology for which extracapsular/ phacoemulsification cataract surgery would be contraindicated. * Subjects with diagnoses of degenerative visual disorders. * Subjects with conditions associated with increased risk of zonular rupture. * Subjects who have had previous corneal surgery in the planned operative eye. * Subjects with irregular corneal astigmatism. * Subjects with clinically significant retinal pigment or epithelium/macular changes. * Subjects with chronic use of systemic steroids or immunosuppressive medications. * Subjects either concurrently participating in another clinical trial or have participated in another clinical trial within 60 days prior to enrollment in this study. * Subjects with a difference in corneal astigmatism measured with the IOL Master and the topographer greater than 0.5 D using vector analysis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Reduction in Absolute Cylinder | 120 - 180 day postoperative visit | Percent reduction in absolute cylinder expressed as a percentage of the intended reduction in cylinder. Cylinder reduction is the measurement for astigmatism reduction. Astigmatism is a form of refractive error that can affect uncorrected visual acuity (at all distances). Reducing cylinder should improve UCVA, but other elements of refractive error, such as myopia or hyperopia, can also affect UCVA. Best corrected visual acuity (BCVA) is not affected by refractive error. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lens Misalignment | 120 - 180 day postoperative visit | This Outcome Measure was evaluated for Crystalens Toric IOL arm only - Toric IOLs require precise alignment to correct astigmatism; control IOLs do not. |
| Visual Acuity | 120 - 180 day postoperative visit | Best-Corrected Distance Visual Acuity (BCDVA) without Glare (logMAR) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Crystalens Toric IOL Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T) | 153 |
| Crystalens IOL Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE) | 76 |
| Total | 229 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to Follow-up | 4 | 0 |
| Overall Study | Subject explanted | 0 | 1 |
| Overall Study | Surgical complication preventing implant | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | Crystalens Toric IOL | Crystalens IOL | Total |
|---|---|---|---|
| Age, Continuous | 70.1 years FULL_RANGE 9 | 69.8 years FULL_RANGE 9.2 | 70.0 years |
| Sex: Female, Male Female | 81 Participants | 42 Participants | 123 Participants |
| Sex: Female, Male Male | 72 Participants | 34 Participants | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 47 / 153 | 29 / 76 |
| serious Total, serious adverse events | 16 / 153 | 6 / 76 |
Outcome results
Primary
Percent Reduction in Absolute Cylinder
Percent reduction in absolute cylinder expressed as a percentage of the intended reduction in cylinder. Cylinder reduction is the measurement for astigmatism reduction. Astigmatism is a form of refractive error that can affect uncorrected visual acuity (at all distances). Reducing cylinder should improve UCVA, but other elements of refractive error, such as myopia or hyperopia, can also affect UCVA. Best corrected visual acuity (BCVA) is not affected by refractive error.
Time frame: 120 - 180 day postoperative visit
Population: The analysis population only includes those for whom the outcome was measured within the specified time frame.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Crystalens Toric IOL | Percent Reduction in Absolute Cylinder | 84.975 percentage of intended cylinder reduct |
| Crystalens IOL | Percent Reduction in Absolute Cylinder | 46.498 percentage of intended cylinder reduct |
Secondary
Lens Misalignment
This Outcome Measure was evaluated for Crystalens Toric IOL arm only - Toric IOLs require precise alignment to correct astigmatism; control IOLs do not.
Time frame: 120 - 180 day postoperative visit
Population: The analysis population only includes those for whom the outcome was measured within the specified time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens Toric IOL | Lens Misalignment | 4.660 degrees | Standard Deviation 4.208 |
Secondary
Visual Acuity
Best-Corrected Distance Visual Acuity (BCDVA) without Glare (logMAR)
Time frame: 120 - 180 day postoperative visit
Population: The analysis population only includes those for whom the outcome was measured within the specified time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens Toric IOL | Visual Acuity | 0.004 logMAR | Standard Deviation 0.097 |
| Crystalens IOL | Visual Acuity | 0.012 logMAR | Standard Deviation 0.094 |