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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. 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 that evaluated 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 showed good outcomes with high patient satisfaction and less dependance on glasses for intermediate and near activities. As technology evolves, new lens models are available in the market. The purpose of this study is to evaluate the latest EDOF and a hybrid multifocal lenses when combined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symfony & Synergy IOL combination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symfony & Synergy IOL combination | Device | The Symfony IOL will be implanted in the dominant eye while the Synergy IOL will be implanted in the non-dominant eye. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Defocus Curve | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction Questionnaire | Percentage for participants who are completely or mostly satisfied with their overall vision will be assessed | 3 months |
| Spectacle Independence for Near Activities Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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Patients from two ophthalmology clinics.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center For Sight | Venice | Florida | 34285 | United States | ||
| Helga Sandoval |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38305420 | Derived | Soscia WL, DeRojas JO, Mathews PM, Brutsky A, Solomon KD, Potvin R, Sandoval HP. Clinical performance after implantation of an EDOF intraocular lens in the dominant eye and a presbyopia-correcting intraocular lens in the nondominant eye. J Cataract Refract Surg. 2024 Jun 1;50(6):578-584. doi: 10.1097/j.jcrs.0000000000001412. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Symfony & Synergy IOL Combination | Symfony & Synergy IOL combination: The Symfony IOL will be implanted in the dominant eye while the Synergy IOL will be implanted in the non-dominant eye. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Symfony & Synergy IOL Combination | Symfony & Synergy IOL combination: The Symfony IOL will be implanted in the dominant eye while the Synergy IOL will be implanted in the non-dominant eye. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 Defocus Curve | Posted | Mean | Standard Deviation | logMAR | 3 months |
|
|
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 | Symfony & Synergy IOL Combination | Symfony & Synergy IOL combination: The Symfony IOL will be implanted in the dominant eye while the Synergy IOL will be implanted in the non-dominant eye. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Center For Sight | 8438813937 | hsandoval@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 | Aug 18, 2022 | Aug 30, 2023 | 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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Percentage of participants reporting the need to wear glasses all the time for near activities will be assessed.
| 3 months |
| Mt. Pleasant |
| South Carolina |
| 29464 |
| United States |
| years |
|
| 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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| Secondary | Patient Satisfaction Questionnaire | Percentage for participants who are completely or mostly satisfied with their overall vision will be assessed | Posted | Count of Participants | Participants | 3 months |
|
|
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| Secondary | Spectacle Independence for Near Activities Questionnaire | Percentage of participants reporting the need to wear glasses all the time for near activities will be assessed. | Posted | Count of Participants | Participants | 3 months |
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| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
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