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| Name | Class |
|---|---|
| Sengi | INDUSTRY |
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The objective is to assess the visual outcomes and quality of vision of patients receiving the AcrySof® Vivity Intraocular lens (IOL), when implanted in eyes with high ocular axial length (≥24.5mm), after uneventful cataract surgery.
This study is a single-arm unmasked clinical evaluation study of binocular uncorrected visual acuity at distance (6m), intermediate (66cm) and near (40cm), when implanted in eyes with high ocular axial length (≥24.5mm), after successful bilateral cataract surgery. Subjects will be assessed preoperatively, operatively, and at 1 day, 1 week, 1 month, and 3 months postoperatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID) and a satisfaction questionnaire (IOLSAT), as well as measurement of binocular and monocular visual acuities and manifest refraction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral implantation of the Vivity IOL | Vivity intraocular lens (IOL) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivity | Device | Vivity intraocular lens (IOL) |
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| Measure | Description | Time Frame |
|---|---|---|
| Binocular Uncorrected Distance Visual Acuity (logMAR) | Binocular uncorrected distance visual acuity (logMAR) | 3 months postoperatively |
| Binocular Uncorrected Intermediate Visual Acuity (logMAR) | Binocular uncorrected intermediate visual acuity (logMAR) | 3 months postoperatively |
| Binocular Uncorrected Near Visual Acuity (logMAR) | Binocular uncorrected near visual acuity (logMAR) | 3 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Prediction Error | Percentage of eyes with absolute prediction error of 0.5D or less | 3 months postoperatively |
| Binocular Corrected Distance Visual Acuity (logMAR) | Binocular corrected distance visual acuity (logMAR) |
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Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
Inclusion Criteria:
Exclusion Criteria:
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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Subjects ≥50 years of age presenting for cataract surgery who are appropriate candidates for intraocular lens implantation.
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| Name | Affiliation | Role |
|---|---|---|
| James J Wiens, MD | Dr. James J. Wiens Medical Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Image Plus Laser Eye Centre | Winnipeg | Manitoba | R3C4K5 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bilateral Implantation of the Vivity IOL | Vivity intraocular lens (IOL) Vivity: Vivity intraocular lens (IOL) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bilateral Implantation of the Vivity IOL | Vivity intraocular lens (IOL) Vivity: Vivity intraocular lens (IOL) |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Binocular Uncorrected Distance Visual Acuity (logMAR) | Binocular uncorrected distance visual acuity (logMAR) | Posted | Mean | Standard Deviation | logMAR | 3 months postoperatively |
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3 months postoperatively
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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 | Bilateral Implantation of the Vivity IOL | Vivity intraocular lens (IOL) Vivity: Vivity intraocular lens (IOL) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr James Wiens | Image Plus Laser Eye Centre | 1-204-943-6287 | jamesjwiens@gmail.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, 2021 | Aug 28, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| 3 months postoperatively |
| Binocular Distance Corrected Intermediate Visual Acuity (logMAR) | Binocular distance corrected intermediate visual acuity (logMAR) | 3 months postoperatively |
| Binocular Distance Corrected Near Visual Acuity (logMAR) | Binocular distance corrected near visual acuity (logMAR) | 3 months postoperatively |
| Monocular Corrected Distance Visual Acuity (logMAR) | Monocular corrected distance visual acuity (logMAR) | 3 months postoperatively |
| Monocular Distance Corrected Intermediate Visual Acuity (logMAR) | Monocular distance corrected intermediate visual acuity (logMAR) | 3 months postoperatively |
| Monocular Distance Corrected Near Visual Acuity (logMAR) | Monocular distance corrected near visual acuity (logMAR) | 3 months postoperatively |
| Manifest Refraction Spherical Equivalent | Manifest refraction spherical equivalent | 3 months postoperatively |
| Questionnaire | Questionnaire for visual disturbance scores (QUVID) | 3 months postoperatively |
| Percentage of Participants With Spectacle Independence | The Intraocular Lens Satisfaction questionnaire (IOLSAT). Subjects were asked how often they needed to wear eyeglasses to see at distance, intermediate, and near. The percentage was calculated as (# of subjects responding "Never" or "Rarely") divided by (# of subjects) times 100. A higher percentage is a better outcome. | 3 months |
| Binocular Distance-corrected Low Contrast Distance Visual Acuity (logMAR) | Binocular distance-corrected low contrast distance visual acuity (logMAR) | 3 months postoperatively |
| Eyes |
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| years |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
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| Primary | Binocular Uncorrected Intermediate Visual Acuity (logMAR) | Binocular uncorrected intermediate visual acuity (logMAR) | Posted | Mean | Standard Deviation | logMAR | 3 months postoperatively |
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| Primary | Binocular Uncorrected Near Visual Acuity (logMAR) | Binocular uncorrected near visual acuity (logMAR) | Posted | Mean | Standard Deviation | logMAR | 3 months postoperatively |
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| Secondary | Prediction Error | Percentage of eyes with absolute prediction error of 0.5D or less | Posted | Count of Units | Eyes | 3 months postoperatively | Eyes | Eyes |
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| Secondary | Binocular Corrected Distance Visual Acuity (logMAR) | Binocular corrected distance visual acuity (logMAR) | Posted | Mean | Standard Deviation | logMAR | 3 months postoperatively |
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| Secondary | Binocular Distance Corrected Intermediate Visual Acuity (logMAR) | Binocular distance corrected intermediate visual acuity (logMAR) | Posted | Mean | Standard Deviation | logMAR | 3 months postoperatively |
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| Secondary | Binocular Distance Corrected Near Visual Acuity (logMAR) | Binocular distance corrected near visual acuity (logMAR) | Posted | Mean | Standard Deviation | logMAR | 3 months postoperatively |
|
|
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| Secondary | Monocular Corrected Distance Visual Acuity (logMAR) | Monocular corrected distance visual acuity (logMAR) | Posted | Mean | Standard Deviation | logMAR | 3 months postoperatively | Eyes | Eyes |
|
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| Secondary | Monocular Distance Corrected Intermediate Visual Acuity (logMAR) | Monocular distance corrected intermediate visual acuity (logMAR) | Posted | Mean | Standard Deviation | logMAR | 3 months postoperatively | Eyes | Eyes |
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| Secondary | Monocular Distance Corrected Near Visual Acuity (logMAR) | Monocular distance corrected near visual acuity (logMAR) | Posted | Mean | Standard Deviation | logMAR | 3 months postoperatively | Eyes | Eyes |
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| Secondary | Manifest Refraction Spherical Equivalent | Manifest refraction spherical equivalent | Posted | Mean | Standard Deviation | diopter (D) | 3 months postoperatively | Eyes | Eyes |
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| Secondary | Questionnaire | Questionnaire for visual disturbance scores (QUVID) | Posted | Count of Participants | Participants | 3 months postoperatively |
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| Secondary | Percentage of Participants With Spectacle Independence | The Intraocular Lens Satisfaction questionnaire (IOLSAT). Subjects were asked how often they needed to wear eyeglasses to see at distance, intermediate, and near. The percentage was calculated as (# of subjects responding "Never" or "Rarely") divided by (# of subjects) times 100. A higher percentage is a better outcome. | Posted | Count of Participants | Participants | 3 months |
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| Secondary | Binocular Distance-corrected Low Contrast Distance Visual Acuity (logMAR) | Binocular distance-corrected low contrast distance visual acuity (logMAR) | Posted | Mean | Standard Deviation | logMAR | 3 months postoperatively |
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| 0 |
| 20 |
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|---|---|
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