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| Name | Class |
|---|---|
| Sengi | INDUSTRY |
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This study is a single center, ambispective study of visual outcomes after successful bilateral implantation of the Odyssey IOL. Subjects will be assessed at least 2 months postoperatively at a single visit. Clinical evaluations will include administration of the AIOLIS questionnaire, as well as measurement of visual acuities at distance, intermediate, and near, monocular (right eye) and binocular defocus curve, and refractive outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Odyssey IOL | Bilateral Implantation with the Odyssey IOL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Odyssey IOL | Device | Bilateral implantation with the Odyssey IOL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Photopic Visual Acuity | Measured at distance (6m), intermediate at 66cm, and near visual acuity at 40cm and 33cm. | 2 months posoperatively |
| Monocular Photopic Visual Acuity | Measured at distance (6m), intermediate at 66cm, and near visual acuity at 40cm and 33cm. | 2 months posoperatively |
| Monocular Defocus Curve (right eye only) | 2 months posoperatively | |
| Binocular Defocus Curve | 2 months posoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionnaire | The AIOLIS has 37 questions about symptoms, perceptions of general vision, and frequency of wearing glasses or contact lenses. Lower scores for the symptom questions indicate lower frequency and both of visual disturbances. | 2 months posoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients within ± 0.5 D MRSE | Manifest refraction spherical equivalent (MRSE) | 2 months posoperatively |
| Percentage of eyes requiring additional corneal refractive procedures | 2 months postoperative |
Inclusion Criteria:
Exclusion Criteria:
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Eligible test subjects will be aged 40 years and older who underwent bilateral implantation with the Odyssey IOL.
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| Name | Affiliation | Role |
|---|---|---|
| Phillip Brunson, OD | Mann Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mann Eye Institute | Houston | Texas | 76134-2099 | United States |
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| Correlation between pupil size and defocus curve | 2 months postoperative |