N/A N=350 Treatment

Clinical Investigation of the Clareon® Intraocular Lens (IOL)

Cataract

Bottom Line

View on ClinicalTrials.gov: NCT03170154 ↗

Enrolled (actual)

350

Serious AEs

2.5%

Results posted

Mar 2020

Primary outcome: Primary: Percentage of All-implanted Subjects Achieving Monocular Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logMAR or Better at Month 12 Postoperative — 99.7 percentage of subjects

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Clareon aspheric hydrophobic acrylic monofocal IOL (Device)
Age: Adult, Older Adult · 22+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Feb 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of All-implanted Subjects Achieving Monocular Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logMAR or Better at Month 12 Postoperative	99.7	—
PRIMARY Percentage of Best-case Subjects Achieving Monocular BCDVA of 0.3 logMAR or Better at Month 12 Postoperative	99.7	—
PRIMARY Percentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye	0; 2.3; 4.0; 1.4; 27.1; 15.1	—
SECONDARY Mean Absolute IOL Rotation	2.2696	—
SECONDARY Mean Absolute IOL Misplacement	5.1163	—
SECONDARY Mean Absolute IOL Misalignment	5.6762	—

Summary

The objective of this study is to compare visual acuity and adverse event outcomes from the Clareon intraocular lens (IOL) to historical safety and performance endpoint (SPE) rates.

Eligibility Criteria

Key Inclusion Criteria

Planned routine cataract surgery in at least one eye;
Calculated lens power within the available range;
Willing and able to sign an informed consent statement;
Clear intraocular media other than cataract.

Key Exclusion Criteria

Any disease or pathology, other than cataract, that is expected to reduce the potential postoperative best corrected distance visual acuity (BCDVA) to a level worse than 0.30 logMAR;
Previous corneal surgery;
Rubella or traumatic cataract;
Ocular trauma, previous refractive surgery;
Current or recent use of certain medications as specified in the protocol;
Any other ocular or systemic condition that, in the opinion of the Investigator, should exclude the subject from the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03170154). 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.