Cataracts
Conditions
Keywords
Toric IOL
Brief summary
Study evaluates the visual outcomes and patient satisfaction after implantation of a toric intraocular lens (IOL).
Interventions
DEVICEToric IOL (SN60T3)
Each enrolled eye implanted with the AcrySof Toric Model SN60T3 intraocular lens (IOL) for the treatment of cataract.
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
* Diagnosed with Cataracts * Predicted residual corneal astigmatism between 0.75 and 1.03 Diopters (D)
Exclusion criteria
* Preoperative ocular pathology * Planned monovision
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected Distance Visual Acuity | 6 months | Uncorrected Distance Visual Acuity at month 6 measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. It is a unit of measure for visual acuity (VA). |
| Best Corrected Distance Visual Acuity | 6 Months | Best Corrected Distance Visual Acuity at month 6 measured in LogMAR. LogMAR is the logarithm of the minimum angle of resolution. It is a unit of measure for visual acuity (VA). |
| Residual Refractive Cylinder | 6 Month | Residual Refractive Cylinder at month 6 measured in diopters (D). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Survey | 6 months | Satisfaction for daytime distance vision, nighttime distance vision, and indoors distance vision on a scale of 1 to 5, with 1 being very dissatisfied and 5 being very satisfied. |
Countries
United States
Participant flow
Recruitment details
Patients were \>21 years of age, of any race and either gender. Patients had operable cataracts in at least 1 eye and were able to provide informed consent. Patients were free of systemic diseases affecting ocular health and had a predicted residual corneal astigmatism between 0.75 and 1.03 Diopters (D) by the AcrySof Toric calculator.
Pre-assignment details
During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study by meeting all inclusion/exclusion criteria were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| AcrySof Toric T3 Each enrolled eye receives AcrySof Toric SN60T3 IOL | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | AcrySof Toric T3 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 19 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Best Corrected Distance Visual Acuity
Best Corrected Distance Visual Acuity at month 6 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: 6 Months
Population: Data was collected for 29 eyes in 24 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AcrySof Toric T3 | Best Corrected Distance Visual Acuity | 0.02 logMAR | Standard Deviation 0.09 |
Primary
Residual Refractive Cylinder
Residual Refractive Cylinder at month 6 measured in diopters (D).
Time frame: 6 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AcrySof Toric T3 | Residual Refractive Cylinder | 0.4 Diopters | Standard Deviation 0.4 |
Primary
Uncorrected Distance Visual Acuity
Uncorrected Distance Visual Acuity at month 6 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: 6 months
Population: Data was collected for 29 eyes in 24 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AcrySof Toric T3 | Uncorrected Distance Visual Acuity | 0.09 logMAR | Standard Deviation 0.14 |
Secondary
Patient Satisfaction Survey
Satisfaction for daytime distance vision, nighttime distance vision, and indoors distance vision on a scale of 1 to 5, with 1 being very dissatisfied and 5 being very satisfied.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AcrySof Toric T3 | Patient Satisfaction Survey | Daytime Distance Vision | 4.6 Units on a Scale | Standard Deviation 0.6 |
| AcrySof Toric T3 | Patient Satisfaction Survey | Nighttime Distance Vision | 4.4 Units on a Scale | Standard Deviation 0.7 |
| AcrySof Toric T3 | Patient Satisfaction Survey | Indoors Distance Vision | 4.6 Units on a Scale | Standard Deviation 0.7 |