Clinical Investigation of the Clareon® Intraocular Lens (IOL)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Investigation of the Clareon® IOL

Conditions
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Cataract

Intervention / Treatment
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* Device: Clareon aspheric hydrophobic acrylic monofocal IOL


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clareon IOL<br>Clareon aspheric hydrophobic acrylic monofocal IOL implanted in one eye during routine small incision cataract surgery | Device: Clareon aspheric hydrophobic acrylic monofocal IOL<br>* Ultraviolet-absorbing and blue light-filtering IOL composed of high refractive-index foldable and flexible acrylic material. IOLs are implantable medical devices intended for long term use over the lifetime of the cataract subject.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of All-implanted Subjects Achieving Monocular Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logMAR or Better at 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. | Month 12 (postoperative) | 
| Percentage of Best-case Subjects Achieving Monocular BCDVA of 0.3 logMAR or Better at 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. | Month 12 (postoperative) | 
| Percentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye | 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. | Day 0 (operative), up to Month 12 (postoperative) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Absolute IOL Rotation | 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. | Day 0 (operative), Month 6 (postoperative) | 
| Mean Absolute IOL Misplacement | 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. | Day 0 (operative) | 
| Mean Absolute IOL Misalignment | 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. | Day 0 (operative), Month 6 (postoperative) |