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| Name | Class |
|---|---|
| Science in Vision | OTHER |
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Angle Kappa is considered a potential factor in explaining suboptimal outcomes with intraocular lenses (IOLs), particularly multifocal IOLs. Some evidence suggests this is not the case. This study was designed to investigate correlations between angle kappa and post-surgical outcomes with a trifocal IOL.
The main complaint of patients who received a presbyopia correcting lens (regardless of the design) are visual disturbances such as glare, halos (rings around lights), starbursts (rays around light sources), mainly at night. The degree of limitation or how bothered patients are varies from patient to patient. To explain these symptoms different theories have been proposed including splitting the light into different focal points which decreases the intensity of the light reaching the retina. Most factors are common to all patients who received the lens; however, patients are not equally affected by these symptoms. Angle kappa has been considered a factor. Angle κ is the angle between the visual axis (straight line that passes through both the center of the pupil and the center of the fovea) and the pupillary axis (perpendicular line to the surface of the cornea that passes through the center of the pupil).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PanOptix | Participants will receive the PanOptix intraocular lens. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angle Kappa | Diagnostic Test | Angle kappa will be measured using the OPD III scan. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Angle Kappa in Visual Disturbances | Frequency of visual disturbances with magnitude of Angle Kappa | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction With Vision by Magnitude of Angle Kappa | Overall satisfaction score after surgery, categorized by magnitude of angle kappa | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects undergoing bilateral lens extraction and implantation of the presbyopia correcting lens PanOptix.
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| Name | Affiliation | Role |
|---|---|---|
| Kerry Solomon | Carolina Eyecare Physicians | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolina Eyecare Physicians, LLC | Mt. Pleasant | South Carolina | 29464 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | PanOptix | Participants will receive the PanOptix intraocular lens. Angle Kappa: Angle kappa will be measured using the OPD III scan. Visual disturbance questionnaire.: Questionnaire evaluating visual disturbances. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PanOptix | Participants will receive the PanOptix intraocular lens. Angle Kappa: Angle kappa will be measured using the OPD III scan. Visual disturbance questionnaire.: Questionnaire evaluating visual disturbances. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Effect of Angle Kappa in Visual Disturbances | Frequency of visual disturbances with magnitude of Angle Kappa | Posted | Count of Participants | Participants | 3 months |
|
3 months
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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 | PanOptix | Participants will receive the PanOptix intraocular lens. Angle Kappa: Angle kappa will be measured using the OPD III scan. Visual disturbance questionnaire.: Questionnaire evaluating visual disturbances. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Research | Carolina Eyecare Physicians | 8438813937 | hsandoval@cepmd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 11, 2019 | Aug 2, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019591 | Pseudophakia |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Visual disturbance questionnaire. |
| Other |
Questionnaire evaluating visual disturbances. |
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| Eyes |
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| years |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | Participants |
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| Region of Enrollment | Number | participants | Participants |
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| Angle Kappa | Mean | Standard Deviation | mm | Eyes |
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| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Satisfaction With Vision by Magnitude of Angle Kappa | Overall satisfaction score after surgery, categorized by magnitude of angle kappa | Posted | Count of Participants | Participants | 3 months |
|
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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| Sometimes |
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| Most of the time |
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| Always |
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| Sometimes |
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| Most of the time |
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| Always |
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| Neither satisfied nor dissatisfied |
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| Satisfied |
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| Very satisfied |
|