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| Name | Class |
|---|---|
| Sengi | INDUSTRY |
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The objective is to measure the range of vision and patient reported visual disturbances after bilateral implantation for this unique non-diffractive extended depth of focus (EDOF) intraocular lens (IOL) made from the Clareon material.
This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected distance (6m) and intermediate (66cm) visual acuity after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clareon Vivity extended depth of focus (EDOF) intraocular lens | Implantation with the Clareon Vivity extended depth of focus (EDOF) intraocular lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clareon Vivity extended depth of focus (EDOF) intraocular lens | Device | Implantation with the Clareon Vivity extended depth of focus (EDOF) intraocular lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Binocular distance-corrected visual acuity at distance (6m) | 3 months postoperative | |
| Binocular distance-corrected visual acuity at intermediate (66cm) | 3 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of eyes with absolute prediction error less than or equal to 0.50D | 3 months postoperative | |
| Percentage of eyes with refractive astigmatism less than or equal to 0.50 D | 3 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction questionnaire | The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction. | 3 months postoperative |
| Visual disturbances questionnaire |
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
The principal investigator reserves the right to declare a patient ineligible or non- evaluable based on medical evidence that indicates they are unsuitable for the trial.
Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
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Eligible test subjects will be presenting for cataract surgery who are interested in a reduced dependence on spectacles for intermediate and distance vision, and who are considered appropriate candidates for EDOF lens implantation.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Nagy, MD | Vision North Eye Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vision North Eye Centre | Terrace | British Columbia | V8G 1V7 | Canada |
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Questionnaire for Visual Disturbances (QUVID). Lower scores indicate less frequent, severe, or bothersome visual disturbances.
| 3 months postoperative |
| Binocular uncorrected and distance-corrected visual acuity at near (40cm) | 3 months postoperative |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D007910 | Lenses, Intraocular |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
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