Cataract
Conditions
Keywords
Astigmatism, intraocular lens, multifocal
Brief summary
The study will evaluate visual acuity and visual function with a 'blended' ReSTOR Toric intraocular lens (IOL) implantation after cataract surgery.
Detailed description
The objective is to provide a normative standard for refractive and visual outcomes in eyes with significant corneal astigmatism undergoing cataract surgery with the Alcon Toric ReSTOR lens. Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye.
Interventions
DEVICEReSTOR Toric
ReSTOR Toric bilateral IOL implantation
Sponsors
SiV Consulting
Gainesville Eye Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a prospective, single center, open clinical trial to collect normative performance data.
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in the eligible eye. * Bilateral visually-significant cataracts * 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) * Regular corneal astigmatism of 1.00D to 2.50D in both eyes * Potential postoperative acuity of 20/25 or better
Exclusion criteria
* If any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residual Refractive Cylinder | 3 months | Manifest postoperative refractive cylinder (measured in diopters, with a phoropter or trial lens set) after cataract surgery and IOL implantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monocular Uncorrected Distance Visual Acuity | 3 months | Monocular uncorrected distance visual acuity measured in logMAR notation |
| Monocular Uncorrected Intermediate Visual Acuity | 3 months | Monocular Uncorrected intermediate visual acuity measured in logMAR notation (log of the minimum angle of resolution) |
| Monocular Best Corrected Distance Visual Acuity | 3 months | Monocular best corrected distance visual acuity measured in logMAR notation |
| Monocular Best Distance-corrected Intermediate Visual Acuity | 3 months | Monocular best distance-corrected intermediate visual acuity in logMAR notation |
| Monocular Best Distance-corrected Near Visual Acuity | 3 months | Monocular best distance-corrected near visual acuity measured in logMAR notation |
| Binocular Uncorrected Near Visual Acuity | 3 months | Binocular uncorrected near (40cm) visual acuity measured in logMAR notation |
| Binocular Uncorrected Distance Visual Acuity | 3 months | Binocular uncorrected distance visual acuity measured in logMAR notation |
| Monocular Uncorrected Near Visual Acuity | 3 months | Monocular uncorrected near visual acuity measuring in logMAR |
| Binocular Best-corrected Distance Visual Acuity | 3 months | Binocular best-corrected distance visual acuity measured in logMAR notation |
| Binocular Best Distance-corrected Intermediate Visual Acuity | 3 months | Binocular best distance-corrected intermediate (60cm) visual acuity |
| Binocular Best Distance-corrected Near Visual Acuity | 3 months | Binocular best distance-corrected near (40cm) visual acuity |
| IOL Orientation | 3 months | Postoperative orientation changes with the Toric ReSTOR IOL up to 3 months after surgery will be measured by determining the angle of orientation of the IOL in degrees (0-180) using a slit lamp. |
| Binocular Best Distance-corrected Defocus Curve | 3 months | Binocular best distance-corrected defocus curve. |
| Binocular Uncorrected Defocus Curve. | 3 months | Binocular uncorrected defocus curve, from +1.0D to -4.00D in 0.50D increments |
| Subjective Visual Quality | 3 months | Quality of vision, measured with a subjective questionnaire (Q of V). Frequency, Severity and Degree of Bother aggregate statistics. Scored on a Rasch scale (0-100) where lower is better. |
| Binocular Uncorrected Intermediate Visual Acuity | 3 months | Binocular uncorrected intermediate (60cm) visual acuity |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ReSTOR Toric Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation.
ReSTOR Toric: ReSTOR Toric bilateral IOL implantation | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | ReSTOR Toric | — |
|---|---|---|
| Age, Continuous | 69 years STANDARD_DEVIATION 9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 29 Participants | — |
| Sex: Female, Male Female | 18 Participants | — |
| Sex: Female, Male Male | 11 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
Primary
Residual Refractive Cylinder
Manifest postoperative refractive cylinder (measured in diopters, with a phoropter or trial lens set) after cataract surgery and IOL implantation
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ReSTOR Toric | Residual Refractive Cylinder | 0.02 diopters | Standard Deviation 0.08 |
Secondary
Binocular Best-corrected Distance Visual Acuity
Binocular best-corrected distance visual acuity measured in logMAR notation
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ReSTOR Toric | Binocular Best-corrected Distance Visual Acuity | -0.03 logMAR | Standard Deviation 0.05 |
Secondary
Binocular Best Distance-corrected Defocus Curve
Binocular best distance-corrected defocus curve.
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ReSTOR Toric | Binocular Best Distance-corrected Defocus Curve | Defocus +1.00 | .24 logMAR Acuity | Standard Deviation 0.2 |
| ReSTOR Toric | Binocular Best Distance-corrected Defocus Curve | Defocus +0.50 | .07 logMAR Acuity | Standard Deviation 0.11 |
| ReSTOR Toric | Binocular Best Distance-corrected Defocus Curve | Defocus 0.00 | -.01 logMAR Acuity | Standard Deviation 0.07 |
| ReSTOR Toric | Binocular Best Distance-corrected Defocus Curve | Defocus -4.00 | .55 logMAR Acuity | Standard Deviation 0.19 |
| ReSTOR Toric | Binocular Best Distance-corrected Defocus Curve | Defocus -3.50 | .40 logMAR Acuity | Standard Deviation 0.15 |
| ReSTOR Toric | Binocular Best Distance-corrected Defocus Curve | Defocus -3.00 | .28 logMAR Acuity | Standard Deviation 0.12 |
| ReSTOR Toric | Binocular Best Distance-corrected Defocus Curve | Defocus -2.50 | .19 logMAR Acuity | Standard Deviation 0.11 |
| ReSTOR Toric | Binocular Best Distance-corrected Defocus Curve | Defocus -2.00 | .16 logMAR Acuity | Standard Deviation 0.11 |
| ReSTOR Toric | Binocular Best Distance-corrected Defocus Curve | Defocus -1.50 | .21 logMAR Acuity | Standard Deviation 0.11 |
| ReSTOR Toric | Binocular Best Distance-corrected Defocus Curve | Defocus -1.00 | .19 logMAR Acuity | Standard Deviation 0.08 |
| ReSTOR Toric | Binocular Best Distance-corrected Defocus Curve | Defocus -0.50 | 0.08 logMAR Acuity | Standard Deviation 0.1 |
Secondary
Binocular Best Distance-corrected Intermediate Visual Acuity
Binocular best distance-corrected intermediate (60cm) visual acuity
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ReSTOR Toric | Binocular Best Distance-corrected Intermediate Visual Acuity | -0.06 logMAR | Standard Deviation 0.03 |
Secondary
Binocular Best Distance-corrected Near Visual Acuity
Binocular best distance-corrected near (40cm) visual acuity
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ReSTOR Toric | Binocular Best Distance-corrected Near Visual Acuity | 0.01 logMAR | Standard Deviation 0.01 |
Secondary
Binocular Uncorrected Defocus Curve.
Binocular uncorrected defocus curve, from +1.0D to -4.00D in 0.50D increments
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ReSTOR Toric | Binocular Uncorrected Defocus Curve. | Defocus -4.00 | .55 logMAR Acuity | Standard Deviation 0.19 |
| ReSTOR Toric | Binocular Uncorrected Defocus Curve. | Defocus -3.50 | .41 logMAR Acuity | Standard Deviation 0.16 |
| ReSTOR Toric | Binocular Uncorrected Defocus Curve. | Defocus -3.00 | .29 logMAR Acuity | Standard Deviation 0.13 |
| ReSTOR Toric | Binocular Uncorrected Defocus Curve. | Defocus -2.50 | .18 logMAR Acuity | Standard Deviation 0.11 |
| ReSTOR Toric | Binocular Uncorrected Defocus Curve. | Defocus 1.00 | .22 logMAR Acuity | Standard Deviation 0.2 |
| ReSTOR Toric | Binocular Uncorrected Defocus Curve. | Defocus 0.50 | .07 logMAR Acuity | Standard Deviation 0.11 |
| ReSTOR Toric | Binocular Uncorrected Defocus Curve. | Defocus 0.00 | -.01 logMAR Acuity | Standard Deviation 0.08 |
| ReSTOR Toric | Binocular Uncorrected Defocus Curve. | Defocus -2.00 | .16 logMAR Acuity | Standard Deviation 0.11 |
| ReSTOR Toric | Binocular Uncorrected Defocus Curve. | Defocus -1.50 | .20 logMAR Acuity | Standard Deviation 0.11 |
| ReSTOR Toric | Binocular Uncorrected Defocus Curve. | Defocus -1.00 | .19 logMAR Acuity | Standard Deviation 0.08 |
| ReSTOR Toric | Binocular Uncorrected Defocus Curve. | Defocus -0.50 | 0.09 logMAR Acuity | Standard Deviation 0.1 |
Secondary
Binocular Uncorrected Distance Visual Acuity
Binocular uncorrected distance visual acuity measured in logMAR notation
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ReSTOR Toric | Binocular Uncorrected Distance Visual Acuity | -0.01 logMAR | Standard Deviation 0.07 |
Secondary
Binocular Uncorrected Intermediate Visual Acuity
Binocular uncorrected intermediate (60cm) visual acuity
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ReSTOR Toric | Binocular Uncorrected Intermediate Visual Acuity | -0.02 logMAR | Standard Deviation 0.07 |
Secondary
Binocular Uncorrected Near Visual Acuity
Binocular uncorrected near (40cm) visual acuity measured in logMAR notation
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ReSTOR Toric | Binocular Uncorrected Near Visual Acuity | 0.01 logMAR | Standard Deviation 0.08 |
Secondary
IOL Orientation
Postoperative orientation changes with the Toric ReSTOR IOL up to 3 months after surgery will be measured by determining the angle of orientation of the IOL in degrees (0-180) using a slit lamp.
Time frame: 3 months
Population: Subjects are enrolled, eyes (2x subjects) were evaluated for some tests.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ReSTOR Toric | IOL Orientation | 56 Eyes with < 5 degrees rot'n from 1-3 mos |
Secondary
Monocular Best Corrected Distance Visual Acuity
Monocular best corrected distance visual acuity measured in logMAR notation
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ReSTOR Toric | Monocular Best Corrected Distance Visual Acuity | .04 logMAR | Standard Deviation 0.09 |
Secondary
Monocular Best Distance-corrected Intermediate Visual Acuity
Monocular best distance-corrected intermediate visual acuity in logMAR notation
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ReSTOR Toric | Monocular Best Distance-corrected Intermediate Visual Acuity | .06 logMAR | Standard Deviation 0.11 |
Secondary
Monocular Best Distance-corrected Near Visual Acuity
Monocular best distance-corrected near visual acuity measured in logMAR notation
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ReSTOR Toric | Monocular Best Distance-corrected Near Visual Acuity | .11 logMAR | Standard Deviation 0.12 |
Secondary
Monocular Uncorrected Distance Visual Acuity
Monocular uncorrected distance visual acuity measured in logMAR notation
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ReSTOR Toric | Monocular Uncorrected Distance Visual Acuity | 0.04 logMAR | Standard Deviation 0.09 |
Secondary
Monocular Uncorrected Intermediate Visual Acuity
Monocular Uncorrected intermediate visual acuity measured in logMAR notation (log of the minimum angle of resolution)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ReSTOR Toric | Monocular Uncorrected Intermediate Visual Acuity | 0.06 logMAR | Standard Deviation 0.11 |
Secondary
Monocular Uncorrected Near Visual Acuity
Monocular uncorrected near visual acuity measuring in logMAR
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ReSTOR Toric | Monocular Uncorrected Near Visual Acuity | 0.12 logMAR | Standard Deviation 0.11 |
Secondary
Subjective Visual Quality
Quality of vision, measured with a subjective questionnaire (Q of V). Frequency, Severity and Degree of Bother aggregate statistics. Scored on a Rasch scale (0-100) where lower is better.
Time frame: 3 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| ReSTOR Toric | Subjective Visual Quality | Frequency | 32 score on a Rasch scale (0-100) |
| ReSTOR Toric | Subjective Visual Quality | Severity | 22 score on a Rasch scale (0-100) |
| ReSTOR Toric | Subjective Visual Quality | Degree of Bother | 0 score on a Rasch scale (0-100) |