Visual Outcomes and Patient Satisfaction With Implantation of the Clareon Monofocal IOL With the New Clareon Manual Monarch IV IOL Delivery System

Study Overview
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Brief Summary
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To evaluate visual outcomes, in-the-bag placement and patient satisfaction in patients implanted with either Clareon monofocal or Clareon monofocal toric IOLs with the Monarch IV inserter and targeted for emmetropia.

Detailed Description
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This study is a single-arm clinical evaluation study of visual performance and patient satisfaction, after successful bilateral cataract surgery. Subjects will be assessed pre- operatively, operatively and at 1 month and 3 months post-operatively. Clinical evaluations will include measurement of bilateral visual acuity, manifest refraction, and IOLSAT questionnaire.

Official Title
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Visual Outcomes and Patient Satisfaction With Implantation of the Clareon Monofocal IOL With the New Clareon Manual Monarch IV IOL Delivery System

Conditions
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Cataract

Intervention / Treatment
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* Device: Clareon monofocal Intraocular lens (toric and non-toric models)


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 cataract surgical patients over the age of 45 with visually significant bilateral cataracts (glare visual acuity 20/40 or worse with BCVA testing), with planned cataract extraction using phacoemulsification, clear corneal incision and Clareon monofocal or Clareon toric with Monarch IV. Able to provide written informed consent for participation in the study. All eyes will be in the range of availability for Clareon monofocal and Clareon toric with Monarch IV. Expected visual potential of 20/25 Snellen (0.10 logMAR) or better in each eye. 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. Visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery. History of neovascular AMD, diabetic macular edema, unstable proliferative diabetic retinopathy, geographic atrophy, branch retinal artery or branch retinal vein occlusion, central retinal artery or central retinal vein occlusion, moderate to severe epiretinal membrane, severe dry eye. History of intraocular infection including HSV keratitis, VZV keratitis, endophthalmitis. History of previous ocular surgery, including corneal refractive surgery, eye trauma or retinal detachment surgery. History of rheumatoid arthritis, ocular cicatricial pemphigoid, or Steven's Johnson Syndrome. History of glaucoma. 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: 45 Years

Sexes Eligible for Study
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All

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 Intraocular lens (toric and non-toric models)<br>Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter | Device: Clareon monofocal Intraocular lens (toric and non-toric models)<br>* Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular uncorrected distance visual acuity (6m) |  | 3 months postoperative | 
| Binocular uncorrected distance visual acuity (6m) |  | 3 months postoperative | 
| Binocular corrected distance visual acuity (6m) |  | 3 months postoperative | 
| Monocular corrected distance visual acuity (6m) |  | 3 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular uncorrected intermediate visual acuity (66cm) |  | 3 months postoperative | 
| Binocular uncorrected intermediate visual acuity (66cm) |  | 3 months postoperative | 
| Binocular distance corrected intermediate visual acuity (66cm) |  | 3 months postoperative | 
| Monocular distance corrected intermediate visual acuity (66cm) |  | 3 months postoperative | 
| Manifest refraction | Residual spherical equivalent refraction, residual sphere, and residual astigmatism | 3 months postoperative | 
| Overall surgeon satisfaction of Monarch IV delivery experience | Score from 1-5. Higher scores indicate high surgeon satisfaction. | Operative visit (Day 0) | 
| Consistency of in-the-bag delivery of IOL during implantation with Monarch IV | Score from 1-4. Higher scores indicate higher consistency. | Operative visit (Day 0) |