Clinical trial NCT06784063: Visual Performance With Clareon® Vivity® Intraocular Lenses (IOLs)
Official title: Evaluation of the Impact of Residual Astigmatism on the Visual Performance With Clareon Vivity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Astigmatism
Keywords: Cataract
IOL
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2025-01-20
Enrollment: 60
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean difference in monocular Best Corrected Distance Visual Acuity (BCDVA) (4 meters) before and after inducing 1.0 diopter (D) astigmatism - WTR
timeFrame: Day 0, coinciding with IOL implantation at least 4 months prior to visit
measure: Mean difference in monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 centimeters) before and after inducing 1.0 D astigmatism - WTR
timeFrame: Day 0, coinciding with IOL implantation at least 4 months prior to visit
measure: Mean difference in monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) before and after inducing 1.0 D astigmatism - WTR
timeFrame: Day 0, coinciding with IOL implantation at least 4 months prior to visit
measure: Mean difference in monocular Best Corrected Distance Visual Acuity (BCDVA) (4 meters) before and after inducing 1.0 diopter (D) astigmatism - ATR
timeFrame: Day 0, coinciding with IOL implantation at least 4 months prior to visit
measure: Mean difference in monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 centimeters) before and after inducing 1.0 D astigmatism.- ATR
timeFrame: Day 0, coinciding with IOL implantation at least 4 months prior to visit
measure: Mean difference in monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) before and after inducing 1.0 D astigmatism - ATR
timeFrame: Day 0, coinciding with IOL implantation at least 4 months prior to visit
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomfield Hills
country: United States
facility: Grosinger, Spigelman & Grey Eye Surgeons, P.C
state: Michigan
city: Dallas
country: United States
facility: Key-Whitman Eye Center
state: Texas
city: Sugar Land
country: United States
facility: Berkeley Eye Center
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Surgical CRD
role: STUDY_DIRECTOR
References: