N/A
Completed N=215
Post-Market Clinical Investigation of the Clareon® IOL
Cataract · Aphakia
Source: ClinicalTrials.gov NCT03316885 ↗
Enrolled (actual)
215
Serious AEs
4.8%
Results posted
Aug 2023
Primary outcomePrimary: Percentage of First Implanted Eyes Achieving Best-Corrected Distance Visual Acuity (BCDVA) of 0.3 Logarithm Minimum Angle of Resolution (logMAR) or Better at 1 Year Post-Implantation — 99.5 percentage of first implanted eyes
Summary
The primary purpose of this study is to evaluate the long-term (3 years) visual acuity and adverse event outcomes for the Clareon® Intraocular Lens (IOL). A comparison to historical safety and performance endpoint (SPE) rates as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014 will be conducted at one year. The secondary purpose of this study is to evaluate the visual acuity outcomes with the Clareon IOL at Years 2 and 3.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of First Implanted Eyes Achieving Best-Corrected Distance Visual Acuity (BCDVA) of 0.3 Logarithm Minimum Angle of Resolution (logMAR) or Better at 1 Year Post-Implantation |
99.5 | — |
| PRIMARY Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 1 Year Post-Implantation |
99.5 | — |
| SECONDARY Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation |
99.5 | — |
| SECONDARY Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation |
98.9 | — |
| SECONDARY Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation |
99.5 | — |
| SECONDARY Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation |
98.9 | — |
| SECONDARY Uncorrected Distance Visual Acuity (UCDVA) at 1 Year Post-Implantation - First Implanted Eye |
0.079 | — |
| SECONDARY UCDVA at 1 Year Post-Implantation - Second Implanted Eye |
0.058 | — |
| SECONDARY UCDVA at 2 Years Post-Implantation - First Implanted Eye |
0.088 | — |
| SECONDARY UCDVA at 2 Years Post-Implantation - Second Implanted Eye |
0.083 | — |
| SECONDARY UCDVA at 3 Years Post-Implantation - First Implanted Eye |
0.091 | — |
| SECONDARY UCDVA at 3 Years Post-Implantation - Second Implanted Eye |
0.086 | — |
Eligibility Criteria
Key Inclusion Criteria
- Diagnosed with bilateral cataracts
- Planned small incision cataract removal surgery
- Able to comprehend and willing to sign a statement of informed consent and complete all required post-implantation visits
Key Exclusion Criteria
- Subjects who may reasonably be expected to require ocular surgical treatment or refractive surgical procedures at any time during the study
- Certain eye conditions, as specified in the protocol, including but not limited to glaucoma, diabetic retinopathy, diabetic macular edema, and macular degeneration
- Pregnant or lactating, current or planned during the course of the study
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03316885). 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.