CompletedNot Applicable

Evaluation of Clareon Vivity/Vivity Toric

United States155 participantsStarted 2023-05-23

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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)

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)

Trial details

NCT IDNCT05852470

SponsorAlcon Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-27

Results submitted2024-10-10

View on ClinicalTrials.gov More Aphakia trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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)

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)