Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study evaluates the visual outcomes and patient satisfaction after implantation of a toric intraocular lens (IOL).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AcrySof Toric T3 | Experimental | Each enrolled eye receives AcrySof Toric Model SN60T3 Intraocular Lens (IOL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toric IOL (SN60T3) | Device | Each enrolled eye implanted with the AcrySof Toric Model SN60T3 intraocular lens (IOL) for the treatment of cataract. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months |
| 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). | 6 Months |
| Residual Refractive Cylinder | Residual Refractive Cylinder at month 6 measured in diopters (D). | 6 Month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AcrySof Toric T3 | Each enrolled eye receives AcrySof Toric SN60T3 IOL |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AcrySof Toric T3 | Each enrolled eye receives AcrySof Toric SN60T3 IOL |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Data was collected for 29 eyes in 24 patients. | Posted | Mean | Standard Deviation | logMAR | 6 months |
|
|
Surgical visit through 6 month postoperative visit.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AcrySof Toric T3 | Each enrolled eye receives AcrySof Toric SN60T3 IOL |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alcon Clinical | Alcon Research, Ltd. | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
Not provided
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 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). | Data was collected for 29 eyes in 24 patients. | Posted | Mean | Standard Deviation | logMAR | 6 Months |
|
|
|
| Primary | Residual Refractive Cylinder | Residual Refractive Cylinder at month 6 measured in diopters (D). | Posted | Mean | Standard Deviation | Diopters | 6 Month |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Units on a Scale | 6 months |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
No paper that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written agreement.
|