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To investigate the patient Quality of Life and satisfaction outcomes of combined cataract surgery with retinal surgery for visually significant epiretinal membrane in patients receiving Vivity IOL versus standard monofocal controls.
The information gained by this study will help understand better the suitability of Vivity IOLs for patients with a common retinal condition and potentially expand access and offering of premium IOLs to help patients gain independence from glasses, which can improve quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vivity Extended Depth of Focus IOL | Experimental |
| |
| Standard monofocal IOL | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cataract surgery | Device | cataract surgery receiving Vivity IOL or standard mono focal controls |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vision Acuity | At the study visit at least 3 months after the combined cataract and retinal surgeries |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast Sensitivity | At the study visit at least 3 months after the combined cataract and retinal surgeries | |
| Patient Reported Outcomes (PRO) on vision-related Quality of Life (QOL) and satisfaction | Using 5-point Likert scale, Research Insight's Validated PRO Questionnaire to assess patient overall satisfaction post-surgery, QOL on driving, reading, computer use, watching TV, sports, and Glare/Haloes. |
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Inclusion Criteria:
Exclusion Criteria:
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Patient Report Outcomes on Quality of Life and satisfaction
After the final results were published and released to the public.
Researchers will have to make explicit request to the corresponding author to determine if any individual participant data can be released. No Personal Health Information and personal identifiers will be shared.
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| retinal surgery | Procedure | Retinal surgery for visually significant epiretinal membrane |
|
| At the study visit at least 3 months after the combined cataract and retinal surgeries |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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