Clinical Investigation of the Clareon® Intraocular Lens (IOL)

Not Applicable

Completed

Conditions: Cataract

Interventions: Device: Clareon aspheric hydrophobic acrylic monofocal IOL

Registration Number: NCT03170154

Lead Sponsor: Alcon Research

Brief 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.

Detailed Description: Upon meeting eligibility criteria, subjects were implanted unilaterally (in one eye) with a Clareon IOL. Subjects attended 7 study visits over a period of approximately 13 months, including 1 preoperative screening visit (Visit 0), 1 operative visit (Visit 00), and 5 postoperative visits (Visits 1-5). Visit day calculations for Visits 1-5 were based off of the day of surgery (Visit 00). Primary endpoint data was collected at the final visit (Month 12). Some sites/subjects participated in a Rotational Stability sub-study. For the non-study eye, the investigator followed standard of care regarding the follow-up, surgery, and intraocular lens choice (as applicable). The non-study eye (fellow eye) was not implanted with the Clareon IOL.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 376

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clareon IOL	Clareon aspheric hydrophobic acrylic monofocal IOL	Clareon aspheric hydrophobic acrylic monofocal IOL implanted in one eye during routine small incision cataract surgery

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye	Day 0 (operative), up to Month 12 (postoperative)	Adverse events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. No hypothesis testing was pre-specified in the protocol.
Percentage of Best-case Subjects Achieving Monocular BCDVA of 0.3 logMAR or Better at Month 12 Postoperative	Month 12 (postoperative)	Visual acuity (VA) of the study eye was assessed with best refractive correction in place under photopic conditions at a distance of 4 meters using an Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. As pre-specified in the protocol, the percentage of subjects with monocular BCDVA of 0.3 logMAR or better at Month 12 was compared to the historical safety and performance endpoint (SPE) rate reported in EN ISO 11979-7:2014. A higher percentage indicates good visual acuity outcomes with most subjects achieving 0.3 logMAR or better.
Percentage of All-implanted Subjects Achieving Monocular Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logMAR or Better at Month 12 Postoperative	Month 12 (postoperative)	Visual acuity (VA) of the study eye was assessed with best refractive correction in place under photopic (well-lit) conditions at a distance of 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. As pre-specified in the protocol, the percentage of subjects with monocular BCDVA of 0.3 logMAR or better at Month 12 was compared to the historical safety and performance endpoint (SPE) rate reported in EN ISO 11979-7:2014. A higher percentage indicates good visual acuity outcomes with most subjects achieving 0.3 logMAR or better.

Secondary Outcome Measures

Name	Time	Method
Mean Absolute IOL Misalignment	Day 0 (operative), Month 6 (postoperative)	IOL misalignment was defined as the summation of IOL misplacement and IOL rotation at Month 6. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL misalignment at 6 months.
Mean Absolute IOL Rotation	Day 0 (operative), Month 6 (postoperative)	IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and Month 6. IOL rotation and measured with slit-lamp photography. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL rotation at 6 months.
Mean Absolute IOL Misplacement	Day 0 (operative)	IOL misplacement was defined as the difference between intended axis of placement and actual axis of IOL orientation on day of surgery. IOL misplacement was measured using slit lamp photography. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL misplacement.