Visual Performance With Clareon® Vivity® Intraocular Lenses (IOLs)

Not Applicable

Completed

• Conditions: Astigmatism

• Registration Number: NCT06784063
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-15
• Study First Posted: 2025-01-20
• Study Start: 2025-04-10
• Primary Completion: 2025-06-13
• Study Completion: 2025-06-13
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-18
• Last Update Posted: 2025-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Able to understand and sign an Institution Review Board-approved informed consent form;
• Willing and able to attend all scheduled study visits as required by the protocol;
• Implanted with study IOLs in both eyes at least 4 months prior to study participation;
• BCDVA of 0 logMAR or better in each eye.

Exclusion Criteria

• Residual astigmatism greater than or equal to 1.00 D;
• Clinically significant ocular conditions as specified in the protocol;
• History of ocular surgeries other than limbal relaxing incisions
• Other protocol-specified exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mean difference in monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) before and after inducing 1.0 D astigmatism - WTR	Day 0, coinciding with IOL implantation at least 4 months prior to visit	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.
Mean difference in monocular Best Corrected Distance Visual Acuity (BCDVA) (4 meters) before and after inducing 1.0 diopter (D) astigmatism - ATR	Day 0, coinciding with IOL implantation at least 4 months prior to visit	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.
Mean difference in monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 centimeters) before and after inducing 1.0 D astigmatism.- ATR	Day 0, coinciding with IOL implantation at least 4 months prior to visit	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.
Mean difference in monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) before and after inducing 1.0 D astigmatism - ATR	Day 0, coinciding with IOL implantation at least 4 months prior to visit	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.
Mean difference in monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 centimeters) before and after inducing 1.0 D astigmatism - WTR	Day 0, coinciding with IOL implantation at least 4 months prior to visit	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.
Mean difference in monocular Best Corrected Distance Visual Acuity (BCDVA) (4 meters) before and after inducing 1.0 diopter (D) astigmatism - WTR	Day 0, coinciding with IOL implantation at least 4 months prior to visit	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.

Trial Locations

Locations (3)

Grosinger, Spigelman & Grey Eye Surgeons, P.C; 🇺🇸 Bloomfield Hills, Michigan, United States

Key-Whitman Eye Center; 🇺🇸 Dallas, Texas, United States

Berkeley Eye Center; 🇺🇸 Sugar Land, Texas, United States