Evaluation of Clareon Vivity/Vivity Toric

Aphakia Clinical Trial

Official title:

PMCF (Post Market Clinical Follow-up) Evaluation of Clareon Vivity/Vivity Toric

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05852470
• Other study ID #: ILE632-C002
• Status: Completed
• Phase: N/A
• Start date: May 23, 2023
• Est. completion date: October 27, 2023

Study information

• Verified date: October 2023
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study seeks to generate clinical data from subjects previously implanted with the Clareon Vivity/Clareon Vivity Toric IOLs or Clareon Monofocal/Clareon Toric IOLs. This study will assess key performance endpoints to support clinical benefits with model-specific data.

Description:

Both eyes of a subject must qualify for enrollment into this study. A total of 2 scheduled visits are planned. The visits include a Screening visit (Visit 0) and a visit after screening (Visit 1). Visit 1 should occur 1 to 14 days after Visit 0. Subject participation is expected to last approximately 2 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: October 27, 2023
• Est. primary completion date: October 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Previous bilateral implantation of Clareon Vivity/Clareon Vivity Toric or Clareon Monofocal/Clareon Toric IOLs for at least 3 months and up to 6 months (90 to 180 days) after second eye implant.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• History of clinically significant ocular co-morbidities that would affect surgical outcomes based on investigator expert medical opinion.
• Subjects who were targeted to monovision defined as = 1.50 Diopter (D) of anisometropia.
• Clinically significant PCO (posterior capsule opacification) affecting vision.
• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Aphakia

Intervention

Device:
• Clareon Vivity/Vivity Toric Extended Vision IOL
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.
• Clareon/Clareon Toric Aspheric IOL
Ultraviolet-absorbing and blue light-filtering 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.

Locations

Country	Name	City	State
United States	Grosinger, Spigelman & Grey Eye Surgeons, P.C.	Bloomfield Hills	Michigan
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Eye Center of Northern Colorado, PC	Fort Collins	Colorado
United States	Eye Care Specialists	Kingston	Pennsylvania
United States	Vance Thompson Vision	Sioux Falls	South Dakota
United States	Associated Eye Care	Stillwater	Minnesota
United States	Wolstan Goldberg Eye Associates	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Binocular photopic BCDVA (logMAR) at 4 m	Visual acuity (VA) will be assessed for both eyes together with best refractive correction in place under photopic (well-lit) conditions at a distance of 4 meters (m) using a visual acuity chart. The subject must be 90-180 days post 2nd eye implantation at time of assessment (Visit 1).	Visit 1 (Day 1-14)
Primary	Mean Binocular photopic DCIVA (logMAR) at 66 cm	Visual acuity (VA) will be assessed for both eyes together with best refractive correction in place under photopic (well-lit) conditions at a distance of 66 centimeters (cm) using a visual acuity chart. The subject must be 90-180 days post 2nd eye implantation at time of assessment (Visit 1).	Visit 1 (Day 1-14)
Secondary	Mean Binocular photopic DCNVA (logMAR) at 40 cm	Visual acuity (VA) will be assessed for both eyes together with distance correction (plus or minus power) in place under photopic (well-lit) conditions at a distance of 40 centimeters (cm) using a visual acuity chart. The subject must be 90-180 days post 2nd eye implantation at time of assessment (Visit 1).	Visit 1 (Day 1-14)
Secondary	Proportion of subjects who respond "Never" to Question 1 of the spectacle use questionnaire (IOLSAT)	The IOLSAT is a patient-reported outcomes questionnaire. Subjects will be asked, "Overall, in the past 7 days, how often did you need to wear eyeglasses to see?" The proportion of subjects who respond "Never" will be reported as a percentage calculated as (# of subjects responding "Never") divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100.The subject must be 90-180 days post 2nd eye implant at the time of Visit 1.	Visit 1 (Day 1-14)