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| Name | Class |
|---|---|
| Sengi | INDUSTRY |
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This is a prospective, single-site, two-surgeon, single-arm, observational study evaluating the Clareon TruPlus IOL. Subjects will be assessed up to 3 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the IOLSAT 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 DCIVA | Measured using a standardized ETDRS chart at 66cm. | 3 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular photopic CDVA | Measured using a standardized ETDRS chart at 4m. | 3 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular photopic DCNVA | Measured using a standardized ETDRS chart at 40cm. | 3 months postoperatively |
| Binocular uncorrected distance visual acuity UDVA (4m) | Measured using a standardized ETDRS charts |
Inclusion Criteria:
Exclusion Criteria:
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Adults over 40 years undergoing age-related cataract surgery with expected visual outcomes of 20/25 or better.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashley Prepeluh | Contact | 952-204-5060 | ashley.prepeluh@ovoeye.com |
| Name | Affiliation | Role |
|---|---|---|
| Martha Whiting, MD | OVO Lasik and Lens LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ovo Lasik + Lens | Recruiting | Saint Louis Park | Minnesota | 55416 | 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 |
| Binocular photopic uncorrected intermediate visual acuity UIVA (66cm) | Measured using a standardized ETDRS charts | 3 months postoperatively |
| Binocular photopic uncorrected near visual acuity UNVA (40cm) | Measured using a standardized ETDRS charts | 3 months postoperatively |
| Monocular photopic uncorrected distance visual acuity UDVA (4m) | Measured using a standardized ETDRS charts | 3 months postoperatively |
| Monocular photopic uncorrected intermediate visual acuity UIVA (66cm) | Measured using a standardized ETDRS charts | 3 months postoperatively |
| Monocular photopic uncorrected near visual acuity UNVA (40cm) | Measured using a standardized ETDRS charts | 3 months postoperatively |
| Monocular photopic corrected distance visual acuity CDVA (4m) | Measured using a standardized ETDRS charts | 3 months postoperatively |
| Monocular photopic distance corrected intermediate visual acuity DCIVA (66cm) | Measured using a standardized ETDRS charts | 3 months postoperatively |
| Monocular photopic distance corrected near visual acuity DCNVA (40cm) | Measured using a standardized ETDRS charts | 3 months postoperatively |
| Monocular defocus curve | Measured using a standardized ETDRS chart | 3 months postoperatively |
| Refractive outcomes | sphere and cylinder will be combined to determine MRSE (sphere + cylinder/2) = MRSE | 3 months postoperatively |
| Satisfaction questionniar | The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher satisfaction. | 3 months postoperatively |