Clinical trial NCT05852470: Evaluation of Clareon Vivity/Vivity Toric
Official title: PMCF (Post Market Clinical Follow-up) Evaluation of Clareon Vivity/Vivity Toric
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphakia
Keywords: Cataract
Intraocular lens
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-05-10
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study seeks to generate clinical data from subjects previously implanted with the Clareon Vivity/Vivity Toric Intraocular Lenses (IOLs) or Clareon Monofocal/Clareon Toric IOLs. This study will assess key performance endpoints to support clinical benefits statements with model-specific data.

Detailed 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). The subject must be 90-180 days post second eye implant at the time of Visit 1. Visit 1 should occur 1 to 14 days after Visit 0. Subject participation is expected to last approximately 2 weeks.

Eligibility criteria: Key Inclusion Criteria:

* Understand and sign an approved Informed Consent form
* Previously implanted in both eyes with 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.

Primary outcomes:
measure: Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant
timeFrame: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
measure: Mean Binocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant
timeFrame: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
Secondary outcomes:
measure: Mean Binocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant
timeFrame: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
measure: Percentage of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant
timeFrame: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Wolstan Goldberg Eye Associates
state: California
city: Fort Collins
country: United States
facility: Eye Center of Northern Colorado, PC
state: Colorado
city: Bloomfield Hills
country: United States
facility: Grosinger, Spigelman & Grey Eye Surgeons, P.C.
state: Michigan
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Kingston
country: United States
facility: Eye Care Specialists
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Carolina Eyecare Physicians LLC
state: South Carolina
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Surgical CRD
role: STUDY_DIRECTOR
References: