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

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)

Population: For this outcome measure, the number of participants/eyes from the Intent-to-Treat (ITT) population (all subjects who were fully enrolled and were binocularly implanted in the study) that were available for analysis at 6 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.

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)

Population: For this outcome measure, the number of participants/eyes from the Intent-to-Treat (ITT) population (all subjects who were fully enrolled and were binocularly implanted in the study) that were available for analysis at 6 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.

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)

Population: For this outcome measure, the number of participants/eyes from the Intent-to-Treat (ITT) population (all subjects who were fully enrolled and were binocularly implanted in the study) that were available for analysis at 6 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.

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)

Population: For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8™ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.

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)

Population: For this outcome measure, the number of participants/eyes from the Intent-to-Treat (ITT) population (all subjects who were fully enrolled and were binocularly implanted in the study) that were available for analysis at 3 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.

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.

Time frame: 6 Months (160-210 days post second eye operative visit)

Population: For this outcome measure, the number of participants/eyes from the Intent-to-Treat (ITT) population (all subjects who were fully enrolled and were binocularly implanted in the study) that were available for analysis at 6 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.

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)

Population: For this outcome measure, the Best-Case analysis was used, which, included subjects with no preoperative ocular pathology, no macular degeneration detected at any time, and no previous surgery for the correction of refractive errors (as defined by ISO 11979-1:2012), as well as no significant macular pathology at any time. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.

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)

Population: For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8™ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.

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)

Population: For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8™ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.

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)

Population: For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8™ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.

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)

Population: For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8™ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.

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)

Population: For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8™ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.

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)

Population: For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8™ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.

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)

Population: A subgroup of subjects from the IC-8™ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.

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)

Population: A subgroup of subjects from the IC-8™ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.

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)

Population: A subgroup of subjects from the IC-8™ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.

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)

Population: A subgroup of subjects from the IC-8™ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.

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)

Population: A subgroup of subjects from the IC-8™ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.

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)

Population: A subgroup of subjects from the IC-8™ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.

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)

Population: A subgroup of subjects from the IC-8™ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.

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)

Population: A subgroup of subjects from the IC-8™ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.

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)

Population: For this outcome measure, the number of participants/eyes from the modified Intent-to-Treat (mITT) population (subjects from the intent to treat population that achieved BCDVA 20/25 or better) that were available for analysis at 3 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.