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| Name | Class |
|---|---|
| Sengi | INDUSTRY |
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This is a prospective, single-arm, single-center, single-surgeon study evaluating the Clareon TruPlus IOL in post-refractive cataract patients. Subjects will be assessed up to 3 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the PRISQ Questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clareon TruPlus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clareon TruPlus | Device | Clareon TruPlus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Binocular photopic BCDVA (4m) | Measured using standard ETDRS charts and recorded in logMAR | 3 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular photopic DCIVA (66cm) | Measured using standard ETDRS charts and recorded in logMAR | 3 months postoperatively |
| Binocular photopic UDVA (4m), UIVA (66cm) | Measured using standard ETDRS charts and recorded in logMAR |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular mesopic BCDVA (4m), DCIVA (66cm) | Measured using standard ETDRS charts and recorded in logMAR | 3 months postoperatively |
| Binocular photopic low contrast (25%) BCDVA | Measured using standard ETDRS charts and recorded in logMAR |
Inclusion Criteria:
Exclusion Criteria:
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35 adults over 45 years old undergoing cataract surgery post-myopic corneal refractive surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Karl Stonecipher, MD | Physicians Protocol | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physicians Protocol | Recruiting | Greensboro | North Carolina | 27401 | United States |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| 3 months postoperatively |
| Monocular photopic BCDVA (4m), DCIVA (66cm) in dominant and non-dominant eye | Measured using standard ETDRS charts and recorded in logMAR | 3 months postoperatively |
| Binocular distance corrected defocus curve (+1.00 to -2.00 in 0.50D, +0.50 to -0.50 in 0.25D) | Measured using standard ETDRS charts and recorded in logMAR | 3 months postoperatively |
| Refractive outcomes | sphere, cylinder, MRSE | 3 months postoperatively |
| 3 months postoperatively |
| Rate of spectacle independence on the PRSIQ questionnaire | Participants are asked to indicate spectacle usage on a scale of "All of the time" to "None of the time" for distance, intermediate, and near vision. | 3 months postoperatively |