AcrySof IQ Toric A-Code Post-Market Clinical Study

IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle between the toric mark on the IOL at Visit 4 and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability. No confirmatory hypothesis testing was conducted.

Time frame: Visit 00 (Day 0 operative), Visit 4 (Day 120-180 postoperative)

Population: All Implanted Analysis Set: All eyes with successful test article implantation and measurable data at Visit 4.

IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle on the IOL at the specified visit and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability.

Time frame: Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)

Population: All Implanted Analysis Set: All eyes with successful test article implantation and measurable data at both visits.

Visual acuity (VA) was tested under well-lit conditions with refractive correction in place using a decimal visual acuity chart set at 5 meters. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. A negative value denotes better than 20/20 visual acuity.

Time frame: Visit 0 (Preoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)

Population: All Implanted Analysis Set: All eyes with successful test article implantation

Sub-surface nano glistening (SSNG) densitometry was measured as the IOL anterior surface light scattering densitometry using Pentacam or Pentacam HR. SSNG was measured in units specific to the device, with a higher number indicating a higher presence of SSNG. Area analysis value is an average value of the IOL anterior surface light scattering densitometry in a certain area.

Time frame: Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)

Population: All Implanted Analysis Set: All eyes with successful test article implantation

Sub-surface nano glistening (SSNG) densitometry was measured as the IOL anterior surface light scattering densitometry using Pentacam or Pentacam HR. SSNG was measured in units specific to the device, with a higher number indicating a higher presence of SSNG. Peak value is the highest value in the IOL anterior surface light scattering densitometry.

Time frame: Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)

Population: All Implanted Analysis Set: All eyes with successful test article implantation

Visual acuity (VA) was tested under well-lit conditions with no refractive correction in place using a decimal visual acuity chart set at 5 meters. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. A negative value denotes better than 20/20 visual acuity.

Time frame: Visit 0 (Preoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)

Population: All Implanted Analysis Set: All eyes with successful test article implantation

A device deficiency was defined as an inadequacy of the medical device with respect to its identity, quality, durability, reliability, safety, or performance.

Time frame: Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)

Population: Safety Analysis Set

A slit lamp examination was performed to evaluate the eye for posterior capsule opacification (that is, the thickening, opacification and clouding of the posterior lens capsule). A neodymium-doped yttrium aluminum garnet (Nd:YAG) laser was used to treat posterior capsule opacification, with treatment determined by the investigator. The presence or absence of Nd:YAG laser treament was recorded.

Time frame: Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140), Unscheduled Visits between Visit 1 and Visit 7

Population: Safety Analysis Set: All eyes with attempted implantation with the test article (successful or aborted after contact with the eye). Note: One subject implanted with the test article discontinued the study prior to the Visit 1 assessment.

A slit lamp examination was performed to evaluate the eye for posterior capsule opacification (that is, the thickening, opacification and clouding of the posterior lens capsule). The presence or absence of PCO was recorded. Clinical significance was determined by the investigator.

Time frame: Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140), Unscheduled Visits between Visit 1 and Visit 7

Population: Safety Analysis Set: All eyes with attempted implantation with the test article (successful or aborted after contact with the eye). Note: One subject implanted with the test article discontinued the study prior to the Visit 1 assessment.

IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle between the toric mark on the IOL at the specified visit and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability.

Time frame: Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)

Population: All Implanted Analysis Set: All eyes with successful test article implantation and measurable data at both visits.

A slit lamp examination was conducted to determine the presence/absence of glistening particles on the implanted IOL. Glistening was reported by on a 4-point scale, where Grade 0 = no glistening; Grade 1 = mild glistening (50/mm3); Grade 2 = moderate glistening (100/mm3); and Grade 3 = severe glistening (200/mm3).

Time frame: Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)

Population: Safety Analysis Set: All eyes with attempted implantation with the test article (successful or aborted after contact with the eye). Note: One subject implanted with the test article discontinued the study prior to the Visit 1 assessment.