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The objective is to assess binocular distance-corrected near (40 cm) visual acuity of patients after uneventful cataract surgery with bilateral implantation of the AcrySof® Vivity Intraocular lens (IOL) when the non-dominant eye is targeted for slight myopia.
This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, 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), patient-reported spectacle independence questionnaire (PRSIQ), 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 |
|---|---|---|---|
| Vivity mini-monovision | Experimental | Subjects will have bilateral Vivity IOL implanted, with a target of slight myopia in the non-dominant eye. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivity Extended Depth of Focus intraocular lens (IOL) | Device | Bilateral implantation of the Vivity lens after cataract surgery, with slight myopia planned in the non-dominant eye. |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Near Visual Acuity | binocular distance-corrected near (40 cm) visual acuity at 3 months postoperative. | 3 months postop |
| Measure | Description | Time Frame |
|---|---|---|
| Prediction Accuracy | Percentage of eyes with postoperative refractive accuracy within 0.5D of target | 3 months postop |
| Spectacle Independence | Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire - "a little of the time" or "none of the time") |
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Inclusion Criteria:
• Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using an EDF IOL
Exclusion Criteria:
• Irregular astigmatism (e.g. keratoconus)
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Newsom, MD | Newsom Eye & Laser Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newsom Eye and Laser Center | Sebring | Florida | 33870 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vivity Monovision Group | Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
All subject who completed their 3M visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vivity Monovision Group | Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia. |
| 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 Near Visual Acuity | binocular distance-corrected near (40 cm) visual acuity at 3 months postoperative. | Posted | Mean | Standard Deviation | logMAR | 3 months postop |
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Surgery to 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 | Vivity Monovision Group | Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| T. Hunter Newsom, MD | Newsom Eye and Laser Center | 813-908-2020 | hunter@newsomeye.net |
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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 | Feb 2, 2020 | Jan 17, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, after successful bilateral cataract surgery.
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| 3 months postop |
| Patient Spectacle Independence | Patients reporting rarely or never needing glasses overall | 3 months postop |
| Number of Participants Rating Frequency of Visual Disturbances as "Never" or "Rarely" | This is the frequency of subjects responding, "Never" or "Rarely" to a question about the frequency of glare, halos and starbursts. | 3 months postop |
| Manifest Refraction | Manifest refraction (residual spherical equivalent refraction) | 3 months postop |
| Residual Cylinder | Residual refractive cylinder after surgery | 3 months |
| Uncorrected Distance Visual Acuity | Bilateral uncorrected distance visual acuity | 3 months postop |
| Uncorrected Intermediate Visual Acuity | Bilateral uncorrected visual acuity at 66 cm | 3 months postop |
| Uncorrected Near Visual Acuity | Bilateral uncorrected near visual acuity at 40 cm | 3 months postop |
| Corrected Distance Visual Acuity | Bliateral corrected distance visual acuity | 3 months postop |
| Distance Corrected Intermediate Visual Acuity | Bliateral distance corrected visual acuity at 66 cm | 3 months postop |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Prediction Accuracy | Percentage of eyes with postoperative refractive accuracy within 0.5D of target | Posted | Count of Units | Eyes | 3 months postop | Eyes | Eyes |
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| Secondary | Spectacle Independence | Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire - "a little of the time" or "none of the time") | All subjects who completed 3M PRSIQ questionnaire successfully | Posted | Count of Participants | Participants | 3 months postop |
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| Secondary | Patient Spectacle Independence | Patients reporting rarely or never needing glasses overall | Posted | Count of Participants | Participants | 3 months postop |
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| Secondary | Number of Participants Rating Frequency of Visual Disturbances as "Never" or "Rarely" | This is the frequency of subjects responding, "Never" or "Rarely" to a question about the frequency of glare, halos and starbursts. | Posted | Count of Participants | Participants | 3 months postop |
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| Secondary | Manifest Refraction | Manifest refraction (residual spherical equivalent refraction) | Each subject had 1 eye targeted for plano, and one eye targeted for myopia. So, each row includes 33 eyes of 33 subjects. | Posted | Mean | Standard Deviation | diopters | 3 months postop | Eyes | Eyes |
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| Secondary | Residual Cylinder | Residual refractive cylinder after surgery | Posted | Mean | Standard Deviation | diopters | 3 months | Eyes | Eyes |
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| Secondary | Uncorrected Distance Visual Acuity | Bilateral uncorrected distance visual acuity | Posted | Mean | Standard Deviation | logMAR | 3 months postop |
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| Secondary | Uncorrected Intermediate Visual Acuity | Bilateral uncorrected visual acuity at 66 cm | Posted | Mean | Standard Deviation | logMAR | 3 months postop |
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| Secondary | Uncorrected Near Visual Acuity | Bilateral uncorrected near visual acuity at 40 cm | Posted | Mean | Standard Deviation | logMAR | 3 months postop |
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| Secondary | Corrected Distance Visual Acuity | Bliateral corrected distance visual acuity | Posted | Mean | Standard Deviation | logMAR | 3 months postop |
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| Secondary | Distance Corrected Intermediate Visual Acuity | Bliateral distance corrected visual acuity at 66 cm | Posted | Mean | Standard Deviation | logMAR | 3 months postop |
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| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
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| Eyes targeted for myopia |
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