Clinical Investigation of a Small Aperture Extended Depth of Focus Intraocular Lens in Patients With Complex Corneas

Study Overview
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Brief Summary
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The objective of this study is to evaluate the clinical outcomes of the IC-8 IOL implanted in patients with complex corneas after crystalline lens removal.

Detailed Description
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This is a prospective, multi-center, open-label, non-randomized, single-arm clinical investigation with planned postoperative follow-up of 4-6 months. The monocular and binocular performance of the subjects will be evaluated. The objective of this study is to evaluate the clinical outcomes of the IC-8 IOL implanted in patients with complex corneas after crystalline lens removal. The co-primary effectiveness endpoints are monocular uncorrected distance, intermediate, and near visual acuities at 4-6 Months postoperative. The primary safety endpoint is best-corrected distance visual acuity at 4-6 Months postoperative. The secondary safety endpoint is photopic and mesopic contrast sensitivity at 4-6 Months postoperative.

Official Title
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Clinical Investigation of a Small Aperture Extended Depth of Focus Intraocular Lens in Patients With Complex Corneas

Conditions
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Cataract, Presbyopia, Irregular Astigmatism

Intervention / Treatment
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* Device: IC-8 Intraocular Lens (IOL)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum 22 years of age; Able to comprehend and have signed a statement of informed consent; Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s); Planned crystalline lens removal by phacoemulsification, with or without femtosecond laser-assisted extraction, and posterior chamber IOL implantation; Planned cataract removal or planned clear lens exchange in both eyes Potential for postoperative best-corrected distance visual acuity (BCDVA) of 20/32 or better after crystalline lens removal; Having complex corneas with irregular astigmatism Having clear central cornea Having best-corrected distance visual acuity (BCDVA) or 20/40 or worse in either eye with or without a glare source (patients with bilateral cataract). Exclusion Criteria: Requiring an IC-8 IOL outside the available spherical power range; Pharmacologically dilated pupil size less than 6 mm in either eye; Preoperative corneal astigmatism >1.50 diopters in the eye to be implanted with the IC-8 IOL; Active or recurrent anterior segment pathology; Presence of ocular abnormalities or conditions (other than corneal irregularities) as specified by the protocol; Congenital bilateral cataracts; Previous ocular surgery as specified by the protocol; Conditions requiring planned ocular surgical intervention; Severe dry eye or other conditions (such as hormonal fluctuations) that could lead to unstable refraction and/or visual acuity measurements or eye discomfort even with ocular lubricants or dry eye medication; Use of systemic or ocular medications as specified by the protocol; Concurrent participation or participation in any clinical investigation up to 30 days prior to preoperative visit; Patient is pregnant or nursing.

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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Accepts Healthy Volunteers

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: IC-8 IOL Group<br>A monofocal or monofocal toric IOL implanted in the first eye of a subject and the IC-8 IOL implanted in the second eye. | Device: IC-8 Intraocular Lens (IOL)<br>* A small aperture extended depth of focus hydrophobic acrylic intraocular lens.<br>* Other names: IC-8 IOL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular uncorrected distance visual acuity (UCDVA) | Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative | 4-6 Months | 
| Monocular uncorrected intermediate visual acuity (UCIVA) | Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative | 4-6 Months | 
| Monocular uncorrected near visual acuity (UCNVA) | Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative | 4-6 Months | 
| Monocular best-corrected distance visual acuity (BCDVA) in the IC-8 IOL eye | Mean best-corrected distance visual acuity (BCDVA) in the IC-8 IOL eye at 4-6 Months is not statistically worse than 0.2 logMAR | 4-6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular and Binocular Contrast Sensitivity | Photopic and Mesopic contrast sensitivity (with and without glare) in each eye and both eyes will be analyzed. No success criterion or hypothesis testing. | 4-6 Months |