Bilateral Cataract
Conditions
Keywords
Astigmatism, cataract, corneal astigmatism, IOL, AcrySof
Brief summary
The purpose of this study is to describe rates of spatial distortions related to intraocular lens (IOL) misalignment for ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9 when implanted bilaterally into the capsular bag following phacoemulsification in adult patients with bilateral cataract and regular corneal astigmatism. Subjects were implanted with the Model SN60T9 in the first operative (study) eye and either Model SN60T9 or Model SN60T8 in the second operative eye.
Interventions
DEVICEACRYSOF® Single-Piece NATURAL Toric IOL Model SN60T9 and Model SN60T8.
ACRYSOF® Single-Piece Toric NATURAL Intraocular Lens (IOL) Model SN60T9 in the first eye and either the ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9 or Model SN60T8 in the second eye.
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults, 21 years of age or older at the time of surgery, of either gender or any race, diagnosed with bilateral cataracts; * Calculated lens power is within the available range; * Willing and able to complete all required postoperative visits; * Planned cataract removal by phacoemulsification; * Potential postoperative visual acuity of 0.2 logMAR or better in study eyes; * Preoperative astigmatism of 4.11 - 4.62 Diopter (D) of predicted crossed cylinder as calculated by the study specific web-based Alcon® Toric IOL Calculator in the first operative eye. Corneal incisions made to reduce astigmatism will not be allowed during the course of the study; * Preoperative astigmatism of 3.60 - 4.62 D of predicted crossed cylinder as calculated by study specific web-based Alcon® Toric IOL Calculator in the second operative eye; * Clear intraocular media other than cataract; * Able to comprehend and sign a statement of informed consent; * Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR; * Pupil size greater than or equal to 6 mm after dilation; * The subject must be able to undergo second eye surgery within 30 days of first eye surgery.
Exclusion criteria
* Irregular corneal astigmatism; * Keratopathy/Keratectasia - any corneal abnormality, other than regular corneal astigmatism, including but not limited to the following; keratoconus, keratoglobus, keratolysis, keratomalacia, keratomycosis, and corneal plana; * Any inflammation or edema (swelling) of the cornea, including but not limited to the following; keratitis, keratoconjunctivitis, and keratouveitis; * Previous corneal refractive surgery; * Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 logMAR; * Amblyopia; * Clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy); * Diabetic retinopathy; * Extremely shallow anterior chamber, not due to swollen cataract; * Microphthalmos; * Previous retinal detachment; * Previous corneal transplant; * Recurrent severe anterior or posterior segment inflammation of unknown etiology; * Rubella or traumatic cataract; * Iris neovascularization; * Uncontrolled glaucoma; * Aniridia; * Optic nerve atrophy; * Pregnancy; * Any subject currently participating in another investigational drug or device study that may confound the results of this investigation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Spatial Distortions Related to Intraocular Lens (IOL) Misalignment | Before Surgery and 180 days after second eye implant | Rates of spatial distortions were evaluated by use of the Visual Distortion Questionnaire (VDQ). The VDQ evaluates the rate & frequency of subjects' experiences with potential visual distortions. The fewer the patients that report visual distortions, the better. The VDQ is a binocular assessment, therfore the subject will use both eyes to evaluate visual distortions. |
| Reduction of Cylinder | 6 months after surgery on second eye | Percentage of subjects with reduction in post-operative refractive cylinder (amount of astigmatism) compared to pre-operative keratometric cylinder in the study eye. The post-operative refractive cylinder should be significantly lower than it was pre-operatively. |
| Lens Axis Misalignment | Time of surgery | Comparison of where the surgeon intended to place the lens axis versus final placement of the lens during the surgical procedure, measured in degrees. This number should be close to zero as there should be minimal difference between the two numbers. This assessment is only for the study eye. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Toric Intraocular Lens ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9 | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Toric Intraocular Lens |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Gender Female | 12 Participants |
| Gender Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 1 / 15 |
Outcome results
Primary
Lens Axis Misalignment
Comparison of where the surgeon intended to place the lens axis versus final placement of the lens during the surgical procedure, measured in degrees. This number should be close to zero as there should be minimal difference between the two numbers. This assessment is only for the study eye.
Time frame: Time of surgery
Population: All implanted subjects were included in this analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Toric Intraocular Lens | Lens Axis Misalignment | 0.3 Degrees |
Primary
Number of Subjects Reporting Spatial Distortions Related to Intraocular Lens (IOL) Misalignment
Rates of spatial distortions were evaluated by use of the Visual Distortion Questionnaire (VDQ). The VDQ evaluates the rate & frequency of subjects' experiences with potential visual distortions. The fewer the patients that report visual distortions, the better. The VDQ is a binocular assessment, therfore the subject will use both eyes to evaluate visual distortions.
Time frame: Before Surgery and 180 days after second eye implant
Population: Per protocol, one subject was excluded from this analysis due to a secondary surgical intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Toric Intraocular Lens | Number of Subjects Reporting Spatial Distortions Related to Intraocular Lens (IOL) Misalignment | Before Surgery | 11 Participants |
| Toric Intraocular Lens | Number of Subjects Reporting Spatial Distortions Related to Intraocular Lens (IOL) Misalignment | After Surgery | 2 Participants |
Primary
Reduction of Cylinder
Percentage of subjects with reduction in post-operative refractive cylinder (amount of astigmatism) compared to pre-operative keratometric cylinder in the study eye. The post-operative refractive cylinder should be significantly lower than it was pre-operatively.
Time frame: 6 months after surgery on second eye
Population: All implanted subjects were included in this analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Toric Intraocular Lens | Reduction of Cylinder | 85.67 Percent reduction of cylinder |