Cataract
Conditions
Keywords
Cataract AcrySof Toric IOL, Bilateral cataract
Brief summary
The purpose of this study is to evaluate the effect that placement and power of the AcrySof Toric has on post-operative visual acuity and spectacle independence for distance vision. This will be determined by comparing manifest refraction pre-operatively and post-operatively and by evaluating the rotational stability of the lens over time.
Interventions
DEVICEAcrySof Toric IOL
Implantation with the AcrySof Toric IOL for cataract replacement and multiple follow-up assessments
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Are a candidate for bilateral implantation * In good general and ocular health, 21 years of age or older, of either gender or any race, diagnosed with age-related cataracts in both eyes * In need of spherical correction between 10.0 Diopter (D) and 30.0 D * Preoperative regular corneal astigmatism, ≥ 1.0 D and ≤ 2.5 D , as measured by keratometry * Willing and able to complete all required postoperative visits * Able to comprehend and sign a statement of informed consent * Pupil dilation ≥ 6.0 mm * Expected to achieve a postoperative logMAR +0.3 or better visual acuity (as assessed by one or more of the following: fundus examination, pinhole visual acuity, and/or PAM evaluation);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity (VA) | Pre-operative, 1 month, 3 month, and 6 month post-operative | Pre-operative and 1 month, 3 month, and 6 month post-operative visual acuity (VA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. It is a unit of measure for visual acuity (VA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spectacle Independence | 6 months post-operative | Percentage of subjects reporting that they never wear glasses at the 6 month post-operative visit |
| IOL Rotation | 6 months post-operative | Evaluation of percentage of patients that experienced rotation of the intraocular lens (IOL) less than or equal to 5 degrees from initial implantation, and less than or equal to 10 degrees from initial implantation. |
Countries
United States
Participant flow
Recruitment details
Subjects \>21 years of age, either sex and any race. Diagnosis of cataracts in one or both eyes.
Pre-assignment details
Subject's eligibility was determined at the preoperative visit. All subjects met inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| AcrySof Toric IOL Implantation of the AcrySof Toric Intraocular lens (IOL) | 120 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Unilateral implantation | 3 |
Baseline characteristics
| Characteristic | AcrySof Toric IOL |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 43 Participants |
| Age, Categorical Between 18 and 65 years | 77 Participants |
| Sex: Female, Male Female | 79 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 120 |
| serious Total, serious adverse events | 0 / 120 |
Outcome results
Primary
Visual Acuity (VA)
Pre-operative and 1 month, 3 month, and 6 month post-operative visual acuity (VA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. It is a unit of measure for visual acuity (VA).
Time frame: Pre-operative, 1 month, 3 month, and 6 month post-operative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AcrySof Toric IOL | Visual Acuity (VA) | Pre-Operative | 0.7 logMAR | Standard Deviation 0.06 |
| AcrySof Toric IOL | Visual Acuity (VA) | 1 Day Post-operative | 0.06 logMAR | Standard Deviation 0.12 |
| AcrySof Toric IOL | Visual Acuity (VA) | 3 Months Post-operative | 0.05 logMAR | Standard Deviation 0.11 |
| AcrySof Toric IOL | Visual Acuity (VA) | 6 Months Post-operative | 0.05 logMAR | Standard Deviation 0.11 |
Secondary
IOL Rotation
Evaluation of percentage of patients that experienced rotation of the intraocular lens (IOL) less than or equal to 5 degrees from initial implantation, and less than or equal to 10 degrees from initial implantation.
Time frame: 6 months post-operative
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AcrySof Toric IOL | IOL Rotation | Less than or equal to 10 degrees | 99 Percentage of Participants |
| AcrySof Toric IOL | IOL Rotation | Less than or equal to 5 degrees | 91 Percentage of Participants |
Secondary
Spectacle Independence
Percentage of subjects reporting that they never wear glasses at the 6 month post-operative visit
Time frame: 6 months post-operative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AcrySof Toric IOL | Spectacle Independence | 69 Percentage of participants |