Monofocal IOL Visual Outcomes When Targeting Mini Monovision

Study Overview
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Brief Summary
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This study is a 3-month, prospective, up to 2 center, bilateral, randomized subject masked clinical evaluation of a monofocal intraocular lens (IOL) when both eyes are targeted for emmetropia and when the non-dominant eye is targeted for mini monovision (-0.75 D) in patients with or without astigmatism undergoing routine cataract surgery.

Official Title
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Visual Performance and Patient Satisfaction With A New Monofocal Intraocular Lens

Conditions
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Cataract, Presbyopia

Intervention / Treatment
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* Device: Eyhance IOL
* Device: Eyhance IOL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is undergoing bilateral cataract extraction with intraocular lens implantation. Willing and able to provide written informed consent for participation in the study Willing and able to comply with scheduled visits and other study procedures. Scheduled to undergo standard cataract surgery in both eyes within 6 - 30 days between surgeries. Subjects who require an IOL power in the range of +5.0 D to +34.0 D only. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes. Exclusion Criteria: Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc. Uncontrolled diabetes. Use of any systemic or topical drug known to interfere with visual performance. Contact lens use during the active treatment portion of the trial. Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis. Clinically significant corneal dystrophy. Irregular astigmatism. History of chronic intraocular inflammation. History of retinal detachment. Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules. Previous intraocular surgery. Previous refractive surgery. Previous keratoplasty Severe dry eye Pupil abnormalities Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy, i.e. LASIK) Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc). Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results. Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.

Ages Eligible for Study
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Minimum Age: 50 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Emmetropia<br>The target refraction for both eyes will be emmetropia (± 0.25 D). | Device: Eyhance IOL<br>* Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target emmetropia OU.<br>Device: Eyhance IOL<br>* Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target mini monovision in the non-dominant eye.<br>|
| Experimental: Mini monovision<br>The target refraction for the dominant eye will be plano (± 0.25 D) and for the non-dominant eye between -0.75D ±0.15. | Device: Eyhance IOL<br>* Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target emmetropia OU.<br>Device: Eyhance IOL<br>* Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target mini monovision in the non-dominant eye.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular distance-corrected intermediate (66 cm) visual acuity at 3 months. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular low contrast distance visual acuity at 3 months |  | 3 months | 
| Distance-corrected near visual acuity at best distance at 3 months |  | 3 months | 
| Spectacle Independence Questionnaire | Participants will answer a questionnaire to determine the need for glasses for near activities | 3 months |