N/A
Completed N=150
Evaluation of Clareon Vivity/Vivity Toric
Aphakia
Source: ClinicalTrials.gov NCT05852470 ↗
Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant — -0.028; -0.062 logMAR
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant |
-0.028; -0.062 | — |
| PRIMARY Mean Binocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant |
0.035; 0.126 | <.001 sig |
| SECONDARY Mean Binocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant |
0.205; 0.334 | <.001 sig |
| SECONDARY 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 |
21.4; 4.1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05852470). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.