Comparison of Visual Outcomes With Mini-Monovision Between a Monofocal and an Adjustable Intraocular Lens

Study Overview
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Brief Summary
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This study is a single center, multi-surgeon, prospective, randomized, comparative study of binocular corrected distance visual acuity (CDVA) after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at up to 6 postoperative visits. Clinical evaluations will include administration of patient reported spectacle usage questionnaire (PRSIQ), as well as measurement of monocular and binocular visual acuities at distance, intermediate, and near, defocus curve, manifest refraction, measurement of higher order aberrations.

Official Title
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Comparison of Visual Outcomes With Mini-Monovision Between a Monofocal and an Adjustable Intraocular Lens

Conditions
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Cataract

Intervention / Treatment
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* Device: Clareon Monofocal
* Device: Light-Adjustable Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes. Adult patients undergoing age-related cataract surgery with expected best- corrected visual outcomes of 20/25 or better Regular corneal astigmatism of 0.75D-2.50D Dilated pupil diameter of 7mm or greater Exclusion Criteria: If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study. Moderate-severe corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative diseases that is expected to cause future vision loss, glaucoma, severe dry eye disease, history of uveitis, ocular herpes simplex virus, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation. History of corneal refractive and intraocular surgery. Patients taking systemic medication that may increase sensitivity to UV light or that may cause toxicity to the retina. The principal investigator reserves the right to declare a patient ineligible or non- evaluable based on medical evidence that indicates they are unsuitable for the trial. Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clareon Monofocal<br> | Device: Clareon Monofocal<br>* Clareon Monofocal Intraocular Lens (toric and non-toric)<br>|
| Light-Adjustable Lens<br> | Device: Light-Adjustable Lens<br>* Light-Adjustable Lens (Intraocular Lens)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular corrected distance visual acuity (CDVA) |  | 3 months postop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular uncorrected distance visual acuity (UDVA) |  | 3 months postop | 
| Binocular distance corrected intermediate visual acuity (DCIVA) |  | 3 months postop | 
| Binocular uncorrected intermediate visual acuity (UIVA) |  | 3 months postop | 
| Monocular corrected distance visual acuity (CDVA) |  | 3 months postop | 
| Monocular uncorrected distance visual acuity (UDVA) |  | 3 months postop | 
| Monocular distance corrected intermediate visual acuity (DCIVA) |  | 3 months postop | 
| Monocular uncorrected intermediate visual acuity (UIVA) |  | 3 months postop |