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The purpose of this study is to generate clinical data to quantify the impact of residual astigmatism on the overall visual performance during distance, intermediate, and near viewing in patients implanted with Clareon Vivity IOLs.
This single visit study is designed to help understand how vision is affected if the eye still has astigmatism after cataract surgery. Participants will be individuals who have already undergone cataract surgery and received a Clareon Vivity IOL in both eyes at least 4 months prior to study enrollment. During the study visit, trial lenses (glass lenses that are used during an eye exam) will be used to temporarily create the effect of astigmatism on the eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clareon Vivity/Vivity Toric | Experimental | Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOLs, with previous implantation defined as at least 4 months prior to study participation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clareon Vivity Extended Vision IOL | Device | Extended vision intraocular lens implanted in the capsular bag of the eye during cataract surgery. IOLs are intended for long term use over the lifetime of the cataract patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean difference in monocular Best Corrected Distance Visual Acuity (BCDVA) (4 meters) before and after inducing 1.0 diopter (D) astigmatism - WTR | BCDVA will be assessed with best refractive correction in place at a distance of 4 meters (m) using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. Trial lenses will be used to induce 1.0 diopter (D) of astigmatism with-the-rule (WTR), defined as -0.50/+1.00 D at approximately 180 degrees on the optical axis. VA will be measured in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism will be reported. One eye (first implanted eye) will be assessed. This is a co-primary endpoint. | Day 0, coinciding with IOL implantation at least 4 months prior to visit |
| Mean difference in monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 centimeters) before and after inducing 1.0 D astigmatism - WTR | DCIVA will be assessed with distance correction in place (plus or minus power) at a distance of 66 cm from the spectacle plane using ETDRS letter charts. Trial lenses will be used to induce 1.0 D of astigmatism WTR, defined as -0.50/+1.00 D at approximately 180 degrees on the optical axis. VA will be measured in logMAR, with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism will be reported. One eye (first implanted eye) will be assessed. This is a co-primary endpoint. | Day 0, coinciding with IOL implantation at least 4 months prior to visit |
| Mean difference in monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) before and after inducing 1.0 D astigmatism - WTR | DCNVA will be assessed with distance correction in place (plus or minus power) at a distance of 40 cm from the spectacle plane using ETDRS letter charts. Trial lenses will be used to induce 1.0 D of astigmatism WTR, defined as -0.50/+1.00 D at approximately 180 degrees on the optical axis. VA will be measured in logMAR, with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism will be reported. One eye (first implanted eye) will be assessed. This is a co-primary endpoint. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Surgical CRD | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grosinger, Spigelman & Grey Eye Surgeons, P.C | Bloomfield Hills | Michigan | 48302 | United States | ||
| Key-Whitman Eye Center |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 29, 2026 | Jun 24, 2026 | 4 |
| ID | Term |
|---|---|
| D001251 | Astigmatism |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
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|
| Day 0, coinciding with IOL implantation at least 4 months prior to visit |
| Mean difference in monocular Best Corrected Distance Visual Acuity (BCDVA) (4 meters) before and after inducing 1.0 diopter (D) astigmatism - ATR | BCDVA will be assessed with best refractive correction in place at a distance of 4 m using ETDRS letter charts. Trial lenses will be used to induce 1.0 D of astigmatism against the rule (ATR), defined as -0.50/+1.00 D at approximately 90 degrees on the optical axis. VA will be measured in logMAR, with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism will be reported. One eye (first implanted eye) will be assessed. This is a co-primary endpoint. | Day 0, coinciding with IOL implantation at least 4 months prior to visit |
| Mean difference in monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 centimeters) before and after inducing 1.0 D astigmatism.- ATR | DCIVA will be assessed with distance correction in place (plus or minus power) at a distance of 66 cm from the spectacle plane using ETDRS letter charts. Trial lenses will be used to induce 1.0 D of astigmatism ATR, defined as -0.50/+1.00 D at approximately 90 degrees on the optical axis. VA will be measured in logMAR, with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism will be reported. One eye (first implanted eye) will be assessed. This is a co-primary endpoint. | Day 0, coinciding with IOL implantation at least 4 months prior to visit |
| Mean difference in monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) before and after inducing 1.0 D astigmatism - ATR | DCNVA will be assessed with distance correction in place (plus or minus power) at a distance of 40 cm from the spectacle plane using ETDRS letter charts. Trial lenses will be used to induce 1.0 D of astigmatism ATR, defined as -0.50/+1.00 D at approximately 90 degrees on the optical axis. VA will be measured in logMAR, with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism will be reported. One eye (first implanted eye) will be assessed. This is a co-primary endpoint. | Day 0, coinciding with IOL implantation at least 4 months prior to visit |
| Dallas |
| Texas |
| 75243 |
| United States |
| Berkeley Eye Center | Sugar Land | Texas | 77478 | United States |