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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
453
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.
A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) bilaterally implanted for lifetime use of the patient.
Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery Center
Tucson, Arizona, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Empire Eye & Laser Center
Bakersfield, California, United States
Harvard Eye Associates
Laguna Hills, California, United States
Altos Eye Physicians
Los Altos, California, United States
Advanced Vision Care
Los Angeles, California, United States
Eye Center of Northern Colorado
Fort Collins, Colorado, United States
Eye Center of North Florida
Panama City, Florida, United States
Chu Vision Institute
Bloomington, Minnesota, United States
Pepose Vision Institute
St Louis, Missouri, United States
Kugler Vision
Omaha, Nebraska, United States
...and 11 more locations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through 12 Months (300-420 days post second eye operative visit)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 Months (160-210 days post second eye operative visit)