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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
| Eric Rosenberg, D.O.,M.Sc.Eng. | UNKNOWN |
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The purpose of this research is to assess the rotational stability of the AcrySof IQ Vivity Extended Vision Toric IOL and Refractive Visual outcome.
Assessment of the rotational stability and Refractive Visual Outcome of the AcrySof IQ Vivity Extended Vision Toric IOL at the end of surgery, post op 1 day, post op 1 week and post op 4 weeks. Participants in this research study are 45 years of age or older and have planned implantation in at least one eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vivity toric IOL implantation arm | Experimental | vivity toric intraocular lens will be implanted in one eye and undergo digital imaging intra op and post op to evaluate for toric intraocular lens rotational stability. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcon Vivity toric intra ocular lens | Device | implanting vivity toric IOL to asses rotational stability. IOL is already FDA approved for implantation at time of cataract surger. Intervention is to assess rotational stability and visual outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Rotational stability of Vivity Toric IOL. | Rotational stability of Vivity Toric IOL will be measured at post op 1 day, post op 1 week and post op 4 weeks. | Five months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of eyes with residual refractive astigmatism, absolute residual astigmatism prediction error, and monocular distance and intermediate visual acuities. | Percentage of eyes with post op rotation of five degrees or less, absolute prediction of error ≤ 0.5 D, residual astigmatism ≤ 0.5 D, residual astigmatism 1.00 D. Monocular and Binocular UDVA, UIVA, UNVA, CDVA, DCIVA and DCNVA. | Five months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Barber, MD | Ophthalmologist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Florida Eye Specialists | DeLand | Florida | 32720 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36894823 | Derived | Barber KM, O'Connor S, Mackinder P, Chih A, Jones B. Rotational stability and refractive outcomes of the DFT/DATx15 toric, extended depth of focus intraocular lens. Int Ophthalmol. 2023 Aug;43(8):2737-2747. doi: 10.1007/s10792-023-02673-7. Epub 2023 Mar 10. |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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Study will include adults (45 years and older) who plan to have cataract extraction and subsequent implantation of AcrySof® IQ Vivity™Extended Vision Toric IOL in at least one eye. Approximately 40 eye will be screened to identify 35 qualified eyes. Within 40 days of screening, qualified subjects will receive cataract surgery followed by implantation of the AcrySof® IQ Vivity™Extended Vision Toric IOL at the surgery visit. If the second eye will participate in the study, subjects will receive the second eye cataract surgery within 60 days of the Screening visit 0. Four postoperative follow up visits are planned to occur at 1-2 days, 7-14 days, and 28-35 days for each enrolled eye. Subject participation in this study is expected to last up to 2 months, including a total of 5 study visits for subjects implanted in one eye and up to 9 visits for subjects implanted in both eyes. Upon completion of the 35 day follow up visit subjects will be exited from the study.
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