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The purpose of this study is to evaluate visual distortions reported by pseudophakic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pseudophakic implanted with toric IOL | Subjects bilaterally implanted with toric IOL |
| |
| Pseudophakic implanted with non-toric IOL | Subjects bilaterally implanted with non-toric IOL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of patient self-assessment | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Distortion Symptoms | Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: "did not experience" (rating = 0), "mild" (rating = 1), "moderate" (rating = 2), or "severe" (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3. | Baseline |
| Visual Distortion Symptoms | Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: "did not experience" (rating = 0), "mild" (rating = 1), "moderate" (rating = 2), or "severe" (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3. | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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Bilaterally-implanted pseudophakic subjects over 22 years of age with astigmatism who meet the inclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact AMO for Trial Locations | Santa Ana | California | 92705 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pseudophakic Implanted With Toric IOL | Subjects implanted with bilateral toric IOL Administration of patient self-assessment |
| FG001 | Pseudophakic Implanted With Non-toric IOL | Subjects implanted with bilateral non-toric IOL Administration of patient self-assessment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pseudophakic Implanted With Toric IOL | Subjects implanted with bilateral toric IOL Administration of patient self-assessment |
| BG001 | Pseudophakic Implanted With Non-toric IOL |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Total participants in the "Pseudophakic implanted with toric IOL" group is 45, but age was not reported for one subject. |
| 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 | Visual Distortion Symptoms | Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: "did not experience" (rating = 0), "mild" (rating = 1), "moderate" (rating = 2), or "severe" (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3. | Of the 45 subjects in the "Pseudophakic implanted with toric IOL" group, one (#102) was excluded due to a protocol deviation (improper method used to simulate visual distortion). | Posted | Mean | Standard Deviation | rating of visual distortion symptoms | Baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pseudophakic Implanted With Toric IOL | Subjects implanted with toric IOL Administration of patient self-assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache with dizziness and nausea | Surgical and medical procedures | Systematic Assessment | Subject reported feeling nausea with a headache and dizziness hours after astigmatism induction |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carrie Garufis | Abbott Medical Optics | 714-566-3728 | carrie.garufis@abbott.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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Subjects implanted with bilateral non-toric IOL
Administration of patient self-assessment
| BG002 | Total | Total of all reporting groups |
| Number |
| participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Pseudophakic Implanted With Non-toric IOL |
Subjects implanted with non-toric IOL Administration of patient self-assessment |
|
|
| Primary | Visual Distortion Symptoms | Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: "did not experience" (rating = 0), "mild" (rating = 1), "moderate" (rating = 2), or "severe" (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3. | Of the 45 subjects in the "Pseudophakic implanted with toric IOL" group, one (#307) was excluded due to a protocol deviation (subject visit was completed outside of the protocol-defined visit interval). | Posted | Mean | Standard Deviation | rating of visual distortion symptoms | 1 week |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Pseudophakic Implanted With Non-toric IOL | Subjects implanted with non-toric IOL Administration of patient self-assessment | 0 | 34 | 2 | 34 |
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| Achiness and pressure | Immune system disorders | Systematic Assessment | Subject experienced achiness and eye pressure after experiencing a lupus flare-up, unrelated to study procedure. |
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Clinical Trial Agreement
| objects appear further away/closer than they are |
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| Objects have different size/shape |
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| physical discomfort related to vision |
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