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| Name | Class |
|---|---|
| Science in Vision | OTHER |
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Current visual outcomes expectations of cataract patients are similar to those of refractive surgery patients. Their desire is to be spectacle independent for far, intermediate and near vision activities. Different options are available including: mono-vision and presbyopia correcting intraocular lenses (IOL). Presbyopia correcting IOLs include accommodative, multifocal, trifocal and extended depth of focus (EDOF) IOLs. The Vivity Extended Vision IOL is not a multifocal IOL but due to its design, it provides better intermediate and near VA compared to a monofocal IOL.
The study is concerned with the visual performance of the Vivity Extended Vision IOL at distance, intermediate and near when one of the eyes is targeted for emmetropia and the other is targeted for slight myopia. Patients will serve as their own controls with visual performance evaluated against corrected vision with a target of emmetropia in both eyes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monovision then emmetropia | Experimental | The target refraction is plano (0.00 D) for the dominant eye and between -0.50 D and -0.75 D for the non-dominant eye. The Vivity IOL will be implanted bilaterally. Corrected vision will involve correcting the dominant eye for emmetropia and the non-dominant eye for -0.50 D. |
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| Emmetropia then monovision | Experimental | Subject's vision will be tested with both eyes corrected for emmetropia. Subjects will then be tested correcting the dominant eye for emmetropia and the non-dominant eye for -0.50 D. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivity IOL emmetropia | Device | The Vivity IOL will be implanted bilaterally in all subjects, tested with correction to bilateral emmetropia. |
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| Measure | Description | Time Frame |
|---|---|---|
| Binocular Uncorrected Near (40 cm) Visual Acuity | The logMAR binocular uncorrected visual acuity at 40 cm will be measured. | 3 months |
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Inclusion Criteria:
Subjects must fulfill the following conditions to qualify for enrollment into the trial
Exclusion Criteria:
Subjects with any of the following conditions on the eligibility exam may not be enrolled into the trial.
The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates the patient is unsuitable for the trial.
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| Name | Affiliation | Role |
|---|---|---|
| Kerry Solomon | Carolina Eyecare Physicians, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolina Eyecare Physicians, LLC | Mt. Pleasant | South Carolina | 29464 | United States |
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A total of 33 subjects were enrolled in the study. One was lost to follow up and one experienced a progression of their macular degeneration, leaving 31 subjects for analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Monovision Then Emmetropia | All study participants received the Vivity IOL in both eyes.
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| FG001 | Emmetropia Then Monovision | All study participants received the Vivity IOL in both eyes.
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| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All study participants received the Vivity IOL in both eyes. The same group of participants were evaluated twice using two different target refractions:
Participants were randomized to which target was evaluated first and there was a 10 minutes break between the 2 evaluations. |
| 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 Near (40 cm) Visual Acuity | The logMAR binocular uncorrected visual acuity at 40 cm will be measured. | Posted | Mean | Standard Deviation | logMAR | 3 months |
|
3 months
AE were collected from the time the ICF was signed to the exit visit at 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 | Monovision | The target refraction is plano (0.00 D) for the dominant eye and between -0.50 D and -0.75 D for the non-dominant eye. The Vivity IOL will be implanted bilaterally. Corrected vision will involve correcting the dominant eye for emmetropia and the non-dominant eye for -0.50 D. Vivity IOL: The Vivity IOL will be implanted bilaterally in all subjects. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Carolina Eyecare Physicians, LLC | 8438813937 | hps@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 | Jun 15, 2020 | Oct 13, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Patients all had same treatment, evaluated postoperatively in two scenarios.
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| Vivity IOL monovision | Device | The Vivity IOL will be implanted bilaterally in all subjects, tested with correction to emmetropia in the dominant eye and -0.50 in the non-dominant eye. |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Emmetropia | Subject's vision will be tested with both eyes corrected for emmetropia. Vivity IOL: The Vivity IOL will be implanted bilaterally in all subjects. | 0 | 31 | 0 | 31 | 0 | 31 |
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