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| Name | Class |
|---|---|
| Science in Vision | OTHER |
| Johnson & Johnson Surgical Vision, Inc. | INDUSTRY |
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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. Some may have already enjoyed freedom from glasses and would like to continue after the cataracts are removed. Different options are available. These options include: mono-vision and presbyopia correcting intraocular lenses (IOL). Presbyopia correcting IOLs include accommodative, multifocals and extended depth of focus (EDOF) IOLs. In a previous study, the visual outcomes of the EDOF Toric IOL were evaluated when both eyes were targeted for plano and when the non-dominant eye was set for a small residual myopic error (-0.50 D) or nanovision in patients with astigmatism. The nanovision approach, appeared to provide similar binocular acuity at distance and intermediate but better acuity at near. The purpose of this study is to evaluate the visual outcomes of an EDOF IOL when combined with a multifocal IOL with a +3.25 D add in patients with or without astigmatism undergoing routine cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tecnis ZLB00 & Symfony IOL | Experimental | The Tecnis multifocal ZLB00 and the Symfony IOLs are presbyopia correcting lenses designed to improve the vision at distance, intermediate and near reducing the need for glasses in patients undergoing cataract surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tecnis ZLB00 & Symfony IOL | Device | The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye. |
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| Measure | Description | Time Frame |
|---|---|---|
| Binocular Uncorrected Near (40 cm) Visual Acuity. | Visual acuity measured at 40 cm without wearing any correction. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Visual Satisfaction After Cataract Surgery: Questionnaire | Patient's overall satisfaction with their vision after cataract surgery assessed by asking the following question: "Taking all things into account, how satisfied or dissatisfied are you with your vision WITHOUT glasses or contacts with your near vision". Possible answers are: Completely satisfied and mostly satisfied, moderately satisfied, a little satisfied or not at all satisfied. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolina Eyecare Physicians, LLC | Mt. Pleasant | South Carolina | 29464 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tecnis ZLB00 & Symfony IOL | The Tecnis multifocal ZLB00 and the Symfony IOLs are presbyopia correcting lenses designed to improve the vision at distance, intermediate and near reducing the need for glasses in patients undergoing cataract surgery. Tecnis ZLB00 & Symfony IOL: The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tecnis ZLB00 & Symfony IOL | The Tecnis multifocal ZLB00 and the Symfony IOLs are presbyopia correcting lenses designed to improve the vision at distance, intermediate and near reducing the need for glasses in patients undergoing cataract surgery. Tecnis ZLB00 & Symfony IOL: The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye. |
| 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. | Visual acuity measured at 40 cm without wearing any correction. | Posted | Mean | Standard Deviation | logMAR | 3 months |
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3 to 5 months
Adverse events were collected from the moment participant signed the informed consent until he or she exited the study.
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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 | Tecnis ZLB00 & Symfony IOL | The Tecnis multifocal ZLB00 and the Symfony IOLs are presbyopia correcting lenses designed to improve the vision at distance, intermediate and near reducing the need for glasses in patients undergoing cataract surgery. Tecnis ZLB00 & Symfony IOL: The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Research | Carolina Eyecare Physicians, LLC | 8438813937 | helga.sandoval@carolinaeyecare.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 | Aug 23, 2018 | Jul 14, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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| 3 months |
| Spectacle Independence: Questionnaire | Patient's spectacle independence was assessed using the "Patient Reported Spectacle Independence Questionnaire (PRSIQ) which includes the following questions: 1. During the LAST 7 DAYS, did you need glasses or contacts for near. Possible answers: Yes No. | 3 months |
| Number of Participants With Visual Symptoms | Number of participants who reported any visual disturbances or symptoms. One participant could report more than one symptom. | 3 months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Patient Visual Satisfaction After Cataract Surgery: Questionnaire | Patient's overall satisfaction with their vision after cataract surgery assessed by asking the following question: "Taking all things into account, how satisfied or dissatisfied are you with your vision WITHOUT glasses or contacts with your near vision". Possible answers are: Completely satisfied and mostly satisfied, moderately satisfied, a little satisfied or not at all satisfied. | Posted | Count of Participants | Participants | 3 months |
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| Secondary | Spectacle Independence: Questionnaire | Patient's spectacle independence was assessed using the "Patient Reported Spectacle Independence Questionnaire (PRSIQ) which includes the following questions: 1. During the LAST 7 DAYS, did you need glasses or contacts for near. Possible answers: Yes No. | Posted | Count of Participants | Participants | 3 months |
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| Secondary | Number of Participants With Visual Symptoms | Number of participants who reported any visual disturbances or symptoms. One participant could report more than one symptom. | Posted | Count of Participants | Participants | 3 months |
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| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
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| Title | Measurements |
|---|---|
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| Sensitivity to light: No |
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