Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and effectiveness of the IC-8 IOL implanted in one eye and a monofocal or monofocal toric IOL implanted in the fellow eye in accordance with the indication.

Detailed Description
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Eligible patients will complete up to 12 study visits over a 12-month period. All subjects will complete a preoperative examination of both eyes to assess study eligibility: operative visit (each eye) and up to 9 postoperative visits (Day 1 - each eye, Week 1 - each eye, Month 1 - each eye or combined, Month 3 - both eyes, Month 6 - both eyes, and Month 12 - both eyes). The first eye must meet specific qualification criteria in order to proceed with IOL implantation in the second eye. The second eye should be implanted within 45 days of the first eye.

Official Title
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Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens

Conditions
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Cataract, Presbyopia

Intervention / Treatment
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* Device: IC-8 IOL Group
* Device: Control Group


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 visits; Planned crystalline lens removal by phacoemulsification, with or without femtosecond laser-assisted extraction, and posterior chamber IOL implantation in both eyes; Cataractous lens changes as demonstrated by best-corrected visual acuity (BCDVA) of 20/40 or worse either with or without a glare source present; Potential for postoperative BCDVA of 20/25 or better in each eye Clear intraocular media, other than cataract. Exclusion Criteria: Requiring an IC-8 intraocular lens outside the available spherical power range Pharmacologically dilated pupil size less than 6 mm in either eye; Inability to achieve stable keratometric readings for contact lens wearers Irregular astigmatism in either eye; Preoperative corneal astigmatism > 1.50 diopters in either eye Active or recurrent anterior segment pathology Presence of ocular abnormalities other than cataract as specified in the protocol Diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye medication; Congenital cataracts; Previous corneal or intraocular surgery History of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention; Systemic conditions as specified in the protocol; Patient is pregnant, plans to become pregnant, or is lactating Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit.

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IC-8 IOL Group<br>A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) implanted in the first eye. The AcuFocus IC-8 IOL implanted in the second eye. | Device: IC-8 IOL Group<br>* A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) implanted in the first eye for use over the lifetime of the patient. The IC-8 IOL implanted in the second eye for use over the lifetime of the patient.<br>* Other names: Intraocular Lens;|
| Active Comparator: Control Group<br>A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) bilaterally implanted. | Device: Control Group<br>* A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) bilaterally implanted for lifetime use of the patient.<br>* Other names: Intraocular lens;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Binocular Photopic Uncorrected Intermediate (66 cm) Visual Acuity (UCIVA) | Visual acuity (VA) was tested binocularly (both eyes) at a distance of 66 cm, without manifest refraction, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart. | 6 Months (160-210 days post second eye operative visit) | 
| Mean Binocular Photopic Uncorrected Near (40 cm) Visual Acuity (UCNVA) | Visual acuity (VA) was tested binocularly (both eyes) at a distance of 40 cm, without manifest refraction, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart. | 6 Months (160-210 days post second eye operative visit) | 
| Mean Binocular Photopic Uncorrected Distance (4 m) Visual Acuity (UCDVA) | Visual acuity (VA) was tested binocularly (both eyes) at a distance of 4 m, with +0.25 D infinity adjustment lens in front of the eyes, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart. | 6 Months (160-210 days post second eye operative visit) | 
| Mean Monocular Photopic Distance-Corrected Intermediate (66 cm) Visual Acuity (DCIVA) in IC-8™ IOL Eyes | Visual acuity (VA) was tested monocularly (each eye) at a distance of 66 cm, with the distance manifest refraction (with infinity adjustment) in place for that eye, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart. | 6 Months (160-210 days post second eye operative visit) | 
| Mean Monocular Photopic Depth of Focus (DOF) in IC-8™ IOL Eyes | Depth of focus was performed monocularly in the IC-8™ IOL Group at the far to near range of vision (+2.00 to -5.00 D), using 100% contrast ETDRS charts in a computerized testing system calibrated for a 4 m test distance, with manifest refraction (no infinity adjustment) in place for the eye(s) being tested. The defocus power was progressively introduced in 0.50 D increments from +2.00 D to +0.50 D and from -0.50 D to -5.00 D, then in 0.25 D increments from +0.50 D to -0.50 D, while visual acuity was measured at each successive defocus step. The depth of focus was estimated as the defocus range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. | 3 Months (60-110 days post second eye operative visit) | 
| Mean Monocular Best-corrected Distance (4 m) Visual Acuity (BCDVA) | Visual acuity (VA) was tested monocularly (each eye) at a distance of 4 m, in photopic conditions, with manifest refraction in place (no infinity adjustment) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart. | 12 Months (300-420 days post second eye operative visit) | 
| Proportion of IC-8™ IOL Eyes Achieving Best-corrected Distance Visual Acuity (BCDVA) 0.3 logMAR or Better Compared to the Safety and Performance Endpoints (SPE) Rates | Visual acuity (VA) was tested monocularly (each eye) at a distance of 4 m, in photopic conditions, with manifest refraction in place (no infinity adjustment) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart. | 12 Months (300-420 days post second eye operative visit) | 
| Proportion of Best-Case IC-8™ IOL Eyes Achieving Best-corrected Distance Visual Acuity (BCDVA) 0.3 logMAR or Better Compared to the Safety and Performance Endpoints (SPE) Rates | Visual acuity (VA) was tested monocularly (each eye) at a distance of 4 m, in photopic conditions, with manifest refraction in place (no infinity adjustment) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart. Monocular BCDVA for the IC-8™ IOL eyes of subjects in the Best-Case population was compared to the safety and performance endpoints (SPE) rate for posterior chamber IOLs. | 12 Months (300-420 days post second eye operative visit) | 
| Rates of IC-8™ IOL Eyes With Cumulative Ocular Serious Adverse Events | The rates of cumulative ocular serious adverse events (SAEs) for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12. | Through 12 Months (300-420 days post second eye operative visit) | 
| Rates of IC-8™ IOL Eyes With Cumulative Postoperative Ocular Adverse Events (Secondary Surgical Interventions) | The rates of cumulative ocular adverse events for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12. | Through 12 Months (300-420 days post second eye operative visit) | 
| Rates of IC-8™ IOL Eyes With Persistent Ocular Serious Adverse Events | The rates of persistent (defined as being unresolved at final scheduled visit) ocular adverse events (AEs) for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12. | Through 12 Months (300-420 days post second eye operative visit) | 
| Rates of IC-8™ IOL Eyes With IC-8™ IOL Removals | The rates of cumulative ocular adverse events for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12. | Through 12 Months (300-420 days post second eye operative visit) | 
| Rates of Eyes With Postoperative Ocular Adverse Events (Other Than Secondary Surgical Intervention), Related to Device (Serious and Non-Serious Combined) | The rates of cumulative ocular adverse events (AEs) for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12. | Through 12 Months (300-420 days post second eye operative visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance to Preoperative Corneal Astigmatism in IC-8™ IOL Eyes With BCDVA 20/25 at 3 Months | Uncorrected-distance visual acuity (UCDVA) in IC-8™ IOL eyes achieving best-corrected distance visual acuity (BCDVA) of 20/25 or better was compared between eyes with preoperative corneal astigmatism < 1.0 D to eyes with 1.0 D to 1.5 D of preoperative corneal astigmatism. | 3 Months (60-110 days post second eye operative visit) | 
| Mean Monocular Photopic Contrast Sensitivity Without Glare | Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested monocularly (each eye) in photopic (well-lit) conditions, without a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better contrast sensitivity results are reflected by a higher numeric value. | 6 Months (160-210 days post second eye operative visit) | 
| Mean Monocular Photopic Contrast Sensitivity With Glare | Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects, and was tested monocularly (each eye) in photopic (well-lit) conditions, with a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value. | 6 Months (160-210 days post second eye operative visit) | 
| Mean Monocular Mesopic Contrast Sensitivity Without Glare | Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested monocularly (each eye) in mesopic (low-light) conditions, without a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value. | 6 Months (160-210 days post second eye operative visit) | 
| Mean Monocular Mesopic Contrast Sensitivity With Glare | Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested monocularly (each eye) in mesopic (low-light) conditions, with a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value. | 6 Months (160-210 days post second eye operative visit) | 
| Mean Binocular Photopic Contrast Sensitivity Without Glare | Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in photopic (well-lit) conditions, without a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value. | 6 Months (160-210 days post second eye operative visit) | 
| Mean Binocular Photopic Contrast Sensitivity With Glare | Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in photopic (well-lit) conditions, with a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value. | 6 Months (160-210 days post second eye operative visit) | 
| Mean Binocular Mesopic Contrast Sensitivity Without Glare | Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in mesopic (low-light) conditions, without a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast, the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value. | 6 Months (160-210 days post second eye operative visit) | 
| Mean Binocular Mesopic Contrast Sensitivity With Glare | Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in mesopic (low-light) conditions, with a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value. | 6 Months (160-210 days post second eye operative visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, Intraocular lens