Visual Function
Conditions
Keywords
Visual function;, Refractive cylinder;, AcrySof® Toric;, AcrySof® Natural
Brief summary
The objective of this study was to evaluate visual function of AcrySof Toric and AcrySof Natural Intraocular Lenses (IOLs) following implant for replacement of cataract.
Interventions
DEVICEAcrySof® Toric IOL
AcrySof® Toric Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery
DEVICEAcrySof Natural
AcrySof Natural Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Bilateral cataracts * 40\ 80 years of age * 4 Days - 1 Week interval between a single patient's surgery * dilated pupil size (in dim light) ≥ 4.0 mm * Anticipated correction with an IOL of +10 Diopters \ +25 Diopters * 0.75 - 2.0 Diopters of astigmatism preoperatively as measured by Keratometry readings
Exclusion criteria
* Preoperative ocular pathology * Previous intraocular or corneal surgery * An increased risk for complications which could require vitreoretinal surgery * Corneal irregularities * Corneal opacities * Current contact lens usage(within 6 months prior to first surgery)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected Visual Acuity (UCVA) | 6 Months after surgery | Uncorrected Visual Acuity (UCVA) from surgery measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire Results | 6 Months | Results of questionnaire rating the quality of distance vision without glasses or contact lenses. Measured on a scale of 0 to 6 (0 = worst, 6 = best). |
Countries
United States
Participant flow
Recruitment details
60 cataract patients were enrolled into the study
Pre-assignment details
Randomized
Participants by arm
| Arm | Count |
|---|---|
| AcrySof Toric IOL AcrySof Toric Intraocular Lens | 30 |
| AcrySof Natural IOL AcrySof Natural Intraocular Lens | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | AcrySof Toric IOL | AcrySof Natural IOL | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 15 Participants | 33 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 15 Participants | 27 Participants |
| Sex: Female, Male Female | 17 Participants | 16 Participants | 33 Participants |
| Sex: Female, Male Male | 13 Participants | 14 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Uncorrected Visual Acuity (UCVA)
Uncorrected Visual Acuity (UCVA) from surgery measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity.
Time frame: 6 Months after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AcrySof Toric IOL | Uncorrected Visual Acuity (UCVA) | 0.06 logMAR | Standard Deviation 0.14 |
| AcrySof Natural IOL | Uncorrected Visual Acuity (UCVA) | 0.14 logMAR | Standard Deviation 0.11 |
Secondary
Questionnaire Results
Results of questionnaire rating the quality of distance vision without glasses or contact lenses. Measured on a scale of 0 to 6 (0 = worst, 6 = best).
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AcrySof Toric IOL | Questionnaire Results | 5.6 Units on a scale | Standard Error 0.7 |
| AcrySof Natural IOL | Questionnaire Results | 4.5 Units on a scale | Standard Error 0.7 |