Trial Outcomes & Findings for ClarVista HARMONI Toric Trial With Intraoperative Exchange (NCT NCT03054649)

NCT ID: NCT03054649

Last Updated: 2020-06-22

Results Overview

A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of added correction needed to compensate for any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number, with a less negative number indicating a lesser amount of added correction. No formal statistical hypothesis testing was planned.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 44 participants
• Primary outcome timeframe: Month 1 postoperative, Month 3 postoperative
• Results posted on: 2020-06-22

Participant Flow

This study was conducted at 1 site located in the Philippines and 1 site located in Mexico. Of the 44 subjects signing an informed consent, 12 failed to meet inclusion/exclusion criteria and 5 were withdrawn prior to implantation when the intraocular lens power was not available due to inventory restrictions.

This reporting group includes all implanted subjects/eyes. Note: One eye in Cohort 2 attempted implantation but was discontinued due to capsular instability (preferred term: Ciliary zonular dehiscence), which was reported as an intraoperative SAE.

Unit of analysis: eyes

Participant milestones

Measure	Cohort 1 Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 2 Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric or non-toric optic)
Overall Study STARTED	27 27	27 26
Overall Study COMPLETED	27 27	27 26
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ClarVista HARMONI Toric Trial With Intraoperative Exchange

Baseline characteristics by cohort

Measure	HMIOL n=27 Participants Implantation with HMIOL system
Age, Continuous	67.4 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race/Ethnicity, Customized Asian	25 Participants n=5 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 1 postoperative, Month 3 postoperative

Population: Per Protocol: All eyes with successful implantation of the HMTIOL and no major protocol deviations.

A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of added correction needed to compensate for any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number, with a less negative number indicating a lesser amount of added correction. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 n=27 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 2 n=15 eyes Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric optic)	Cohort 1 - Month 1 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL Month 1 postoperative	-0.54 diopter Standard Deviation 0.32	-0.75 diopter Standard Deviation 0.31	—	—	—
Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL Month 3 postoperative	-0.58 diopter Standard Deviation 0.42	-0.72 diopter Standard Deviation 0.45	—	—	—

PRIMARY outcome

Timeframe: Month 1 postoperative, Month 3 postoperative

Population: Per Protocol: All eyes with successful implantation of the HMTIOL and no major protocol deviations.

A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number. MRCYL PE was calculated as postoperative MRCYL adjusted to 6 meters minus MRCYL target residual refractive error (TRRE), with a lower absolute value indicating a more accurate cylinder power calculation. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 n=27 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 2 n=15 eyes Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric optic)	Cohort 1 - Month 1 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL Month 1 postoperative	-0.30 diopter Standard Deviation 0.28	-0.53 diopter Standard Deviation 0.36	—	—	—
Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL Month 3 postoperative	-0.33 diopter Standard Deviation 0.33	-0.44 diopter Standard Deviation 0.37	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 0 preoperative), Month 3 postoperative

Population: Per Protocol: All eyes with successful implantation of the HMTIOL and no major protocol deviations.

A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number. Cylinder power reduction was calculated as the absolute preoperative magnitude of corneal cylinder (K) minus the absolute postoperative magnitude of MRCYL at the corneal plane. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 n=27 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 2 n=15 eyes Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric optic)	Cohort 1 - Month 1 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
Mean Reduction in Cylinder Power for Eyes Implanted With HMTIOL	0.79 diopter Standard Deviation 0.56	0.53 diopter Standard Deviation 0.39	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 0 preoperative), Month 3 postoperative

Population: Per Protocol: All eyes with successful implantation of the HMTIOL and no major protocol deviations.

A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number. Cylinder power reduction was calculated as the absolute preoperative magnitude of corneal cylinder (K) minus the absolute postoperative magnitude of MRCYL at the corneal plane. Therefore, the cylindrical power percent reduction was the cylinder power reduction divided by the absolute value of preoperative magnitude of corneal cylinder (K) × 100. A higher number (greater percent reduction) indicates better astigmatism correction by the toric IOL. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 n=27 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 2 n=15 eyes Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric optic)	Cohort 1 - Month 1 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
Mean Percent Reduction in Cylinder Power for Eyes Implanted With HMTIOL	54.9 percent reduction Standard Deviation 29.3	39.5 percent reduction Standard Deviation 34.2	—	—	—

PRIMARY outcome

Timeframe: Month 3 postoperative

Population: Implanted Eye Set: All eyes with successful implantation during surgery, with data at visit

A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). MRSE PE was calculated as postoperative MRSE adjusted to 6 meters minus MRSE target residual refractive error (TRRE). The lower the absolute number, the more accurate the IOL power calculation is. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 n=27 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 2 n=26 eyes Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric optic)	Cohort 1 - Month 1 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
Mean Manifest Refraction Spherical Equivalent (MRSE) Prediction Error (PE)	0.03 diopter Standard Deviation 0.45	-0.12 diopter Standard Deviation 0.43	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative

Population: Implanted Eye Set: All eyes with successful implantation during surgery, with data at visit

IOL orientation was measured with slit-lamp photography. IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and the subsequent postoperative visit. IOL rotation was measured in degrees, with a lower number indicating less rotation. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 n=24 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 2 n=20 eyes Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric optic)	Cohort 1 - Month 1 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
Mean Absolute Rotation of IOL Meridian Rotation from operative to Day 1	1.8 degrees Standard Deviation 1.3	2.1 degrees Standard Deviation 1.4	—	—	—
Mean Absolute Rotation of IOL Meridian Rotation from operative to Week 1	2.4 degrees Standard Deviation 1.4	1.6 degrees Standard Deviation 1.7	—	—	—
Mean Absolute Rotation of IOL Meridian Rotation from operative to Month 1	3.1 degrees Standard Deviation 4.5	2.3 degrees Standard Deviation 1.5	—	—	—
Mean Absolute Rotation of IOL Meridian Rotation from operative to Month 3	3.2 degrees Standard Deviation 4.6	2.2 degrees Standard Deviation 1.6	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative

Population: Implanted Eye Set: All eyes with successful implantation during surgery, with data at visit

IOL orientation was measured with slit-lamp photography. IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and the subsequent postoperative visit. IOL rotation was measured in degrees and is reported categorically. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 n=22 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 2 n=23 eyes Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric optic)	Cohort 1 - Month 1 Postoperative n=24 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative n=23 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1 Rotation from Operative >5 degrees to ≤ 10 degrees	0 eyes	0 eyes	0 eyes	0 eyes	—
Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1 Rotation from Operative ≤ 5 degrees	22 eyes	23 eyes	23 eyes	22 eyes	—
Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1 Rotation from Operative >10 degrees to ≤ 20 degree	0 eyes	0 eyes	0 eyes	0 eyes	—
Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1 Rotation from Operative > 20 degrees	0 eyes	0 eyes	1 eyes	1 eyes	—

PRIMARY outcome

Timeframe: Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative

Population: Implanted Eye Set: All eyes with successful implantation during surgery, with data at visit

IOL orientation was measured with slit-lamp photography. IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and the subsequent postoperative visit. IOL rotation was measured in degrees and is reported categorically. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 n=20 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 2 n=17 eyes Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric optic)	Cohort 1 - Month 1 Postoperative n=18 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative n=19 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2 Rotation from Operative > 20 degrees	0 eyes	0 eyes	0 eyes	0 eyes	—
Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2 Rotation from Operative ≤ 5 degrees	20 eyes	17 eyes	18 eyes	19 eyes	—
Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2 Rotation from Operative >5 degrees to ≤ 10 degrees	0 eyes	0 eyes	0 eyes	0 eyes	—
Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2 Rotation from Operative >10 degrees to ≤ 20 degree	0 eyes	0 eyes	0 eyes	0 eyes	—

PRIMARY outcome

Timeframe: Baseline (Day 0 operative), Week 1 postoperative, Month 1 postoperative, Month 3 postoperative

Population: Implanted Eye Set: All eyes with successful implantation during surgery, with data at visit

Visual Acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with the correction obtained from manifest refraction testing. BCDVA is reported categorically using the Snellen fraction, which compares the participant's result to the result expected from a 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 n=27 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 2 n=27 eyes Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric optic)	Cohort 1 - Month 1 Postoperative n=27 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative n=27 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 20/32 Snellen or Better	70.4 Percentage of eyes	96.3 Percentage of eyes	100.0 Percentage of eyes	96.3 Percentage of eyes	—
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 20/20 Snellen or Better	22.2 Percentage of eyes	66.7 Percentage of eyes	59.3 Percentage of eyes	70.4 Percentage of eyes	—
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 20/25 Snellen or Better	51.9 Percentage of eyes	77.8 Percentage of eyes	85.2 Percentage of eyes	92.6 Percentage of eyes	—
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 20/40 Snellen or Better	92.6 Percentage of eyes	100.0 Percentage of eyes	100.0 Percentage of eyes	96.3 Percentage of eyes	—
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 Worse than 20/40 Snellen	7.4 Percentage of eyes	0.0 Percentage of eyes	0.0 Percentage of eyes	3.7 Percentage of eyes	—

PRIMARY outcome

Timeframe: Baseline (Day 0 operative), Week 1 postoperative, Month 1 postoperative, Month 3 postoperative

Population: Implanted Eye Set: All eyes with successful implantation during surgery, with data at visit

Visual Acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with the correction obtained from manifest refraction testing. UCDVA is reported categorically using the Snellen fraction, which compares the participant's result to the result expected from a 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 n=26 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 2 n=26 eyes Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric optic)	Cohort 1 - Month 1 Postoperative n=26 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative n=26 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 20/20 Snellen or Better	23.1 percentage of eyes	76.9 percentage of eyes	73.1 percentage of eyes	76.9 percentage of eyes	—
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 20/25 Snellen or Better	57.7 percentage of eyes	84.6 percentage of eyes	88.5 percentage of eyes	92.3 percentage of eyes	—
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 20/32 Snellen or Better	76.9 percentage of eyes	96.2 percentage of eyes	92.3 percentage of eyes	100 percentage of eyes	—
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 20/40 Snellen or Better	88.5 percentage of eyes	96.2 percentage of eyes	100.0 percentage of eyes	100.0 percentage of eyes	—
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 Worse than 20/40 Snellen	11.5 percentage of eyes	3.8 percentage of eyes	0.0 percentage of eyes	0.0 percentage of eyes	—

PRIMARY outcome

Timeframe: Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative

Population: Implanted Eye Set: All eyes with successful implantation during surgery, with data at visit

Visual Acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with an optical infinity adjustment of +0.25 diopter (D). The Snellen fraction compares the participant's result to the result expected from a 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 n=27 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 2 n=27 eyes Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric optic)	Cohort 1 - Month 1 Postoperative n=27 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative n=27 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative n=27 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 20/25 Snellen or Better	14.8 percentage of eyes	55.6 percentage of eyes	59.3 percentage of eyes	74.1 percentage of eyes	70.4 percentage of eyes
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 20/20 Snellen or Better	3.7 percentage of eyes	48.1 percentage of eyes	44.4 percentage of eyes	40.7 percentage of eyes	40.7 percentage of eyes
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 20/32 Snellen or Better	14.8 percentage of eyes	77.8 percentage of eyes	88.9 percentage of eyes	92.6 percentage of eyes	92.6 percentage of eyes
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 20/40 Snellen or Better	40.7 percentage of eyes	96.3 percentage of eyes	100.0 percentage of eyes	96.3 percentage of eyes	96.3 percentage of eyes
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 Worse than 20/40 Snellen	59.3 percentage of eyes	3.7 percentage of eyes	0.0 percentage of eyes	3.7 percentage of eyes	3.7 percentage of eyes

PRIMARY outcome

Timeframe: Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative

Population: Implanted Eye Set: All eyes with successful implantation during surgery, with data at visit

Visual Acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with an optical infinity adjustment of +0.25 diopter (D). The Snellen fraction compares the participant's result to the result expected from a 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 n=26 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 2 n=26 eyes Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric optic)	Cohort 1 - Month 1 Postoperative n=26 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative n=26 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative n=26 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 20/20 Snellen or Better	0.0 percentage of eyes	46.2 percentage of eyes	53.8 percentage of eyes	42.3 percentage of eyes	34.6 percentage of eyes
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 20/25 Snellen or Better	3.8 percentage of eyes	65.4 percentage of eyes	76.9 percentage of eyes	73.1 percentage of eyes	69.2 percentage of eyes
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 20/32 Snellen or Better	11.5 percentage of eyes	65.4 percentage of eyes	84.6 percentage of eyes	88.5 percentage of eyes	84.6 percentage of eyes
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 20/40 Snellen or Better	50.0 percentage of eyes	92.3 percentage of eyes	92.3 percentage of eyes	100.0 percentage of eyes	100.0 percentage of eyes
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 Worse than 20/40 Snellen	50.0 percentage of eyes	7.7 percentage of eyes	7.7 percentage of eyes	0.0 percentage of eyes	0.0 percentage of eyes

PRIMARY outcome

Timeframe: Week 1 postoperative, Month 1 postoperative, Month 3 postoperative

Population: All implanted subjects/eyes

Preservation of BCDVA was defined in terms of lines lost when reading the ETDRS chart at each visit compared to the prior best-achieved BCDVA. Loss of < 1 line included subjects with less than a 1 line loss, no change or improvement in BCDVA. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 n=27 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 2 n=27 eyes Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric optic)	Cohort 1 - Month 1 Postoperative n=26 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative n=26 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 Loss >= 4 lines	0 eyes	0 eyes	0 eyes	0 eyes	—
Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 Loss < 1 line	27 eyes	25 eyes	25 eyes	26 eyes	—
Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 Loss >= 1 lines	0 eyes	2 eyes	1 eyes	0 eyes	—
Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 Loss >= 2 lines	0 eyes	1 eyes	0 eyes	0 eyes	—
Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 Loss >= 3 lines	0 eyes	0 eyes	0 eyes	0 eyes	—

PRIMARY outcome

Timeframe: Up to Month 3 postoperative

Population: Safety Analysis Set: All subjects/eyes with attempted study lens implantation (successful or aborted).

Ocular adverse events were identified as outlined in ISO 11979-2014 Annex B. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 n=27 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 2 n=27 eyes Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric optic)	Cohort 1 - Month 1 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
Number of Ocular Adverse Events Through Month 3 Conjunctivitis viral	1 adverse event	0 adverse event	—	—	—
Number of Ocular Adverse Events Through Month 3 Cystoid macular oedema	1 adverse event	1 adverse event	—	—	—
Number of Ocular Adverse Events Through Month 3 Ciliary zonular dehiscence	0 adverse event	1 adverse event	—	—	—
Number of Ocular Adverse Events Through Month 3 Intraocular pressure increased	0 adverse event	1 adverse event	—	—	—
Number of Ocular Adverse Events Through Month 3 Iridocyclitis	0 adverse event	1 adverse event	—	—	—

PRIMARY outcome

Timeframe: Up to Month 3 postoperative

Population: All implanted subjects/eyes

A Device Deficiency (DD) was defined as a failure of the device to meet its performance specifications or expectations, or otherwise not perform as intended. This could include either a malfunction or damage to the device or any part thereof, regardless of the source of malfunction or damage, including user error, and regardless of the presence of injury (or lack thereof) to subject, user, or bystander. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 n=27 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 2 n=26 eyes Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric optic)	Cohort 1 - Month 1 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
Number of Device Deficiencies Post Implantation	0 device deficiency	0 device deficiency	—	—	—

PRIMARY outcome

Timeframe: Up to Month 3 postoperative

Population: All implanted subjects/eyes

A secondary surgical intervention (SSI) was defined as a surgical procedure that occurred after primary implantation and was conducted for the purpose of resolving residual refractive error (RRE) and optimizing visual outcomes. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 n=27 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 2 n=27 eyes Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric optic)	Cohort 1 - Month 1 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
Number of Secondary Surgical Interventions, Other Than Intraroperative Optic Exchange and Rotational Adjustment of the Toric Optic in Cohort 2	0 Secondary surgical interventions	0 Secondary surgical interventions	—	—	—

PRIMARY outcome

Timeframe: Baseline (preoperative), Month 3 postoperative

Population: All implanted subjects/eyes

High quality images of the corneal endothelium (the single layer of cells on the inner surface of the cornea) were taken at the investigative site and sent to an independent central reading center for evaluation. A negative percent change value may indicate a decrease in the ability of the endothelium to maintain its primary function. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 n=27 eyes Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 2 n=26 eyes Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric optic)	Cohort 1 - Month 1 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 1 - Month 3 Postoperative Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
Percent Change in Endothelial Cell Count (ECC) at Month 3	-12.5 percent change Standard Deviation 10.1	-9.0 percent change Standard Deviation 10.3	—	—	—

Adverse Events

Cohort 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 2

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort 1 n=27 participants at risk Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange	Cohort 2 n=27 participants at risk Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric or non-toric optic)
General disorders Eye complication associated with device	0.00% 0/27 • Adverse events were collected from time of consent until study exit: Up to 6 months, including a Day -90 to Day -0 preoperative period and a 3-month postoperative period. An adverse event was defined as any untoward medical event that does not necessarily have a causal relationship to the study device or protocol. Conditions or diseases that were pre-existing and/or chronic but stable were not recorded as adverse events. Similarly, changes in a pre-existing and/or chronic condition or disease that were consistent with natural progression were not recorded as adverse events.	3.7% 1/27 • Number of events 1 • Adverse events were collected from time of consent until study exit: Up to 6 months, including a Day -90 to Day -0 preoperative period and a 3-month postoperative period. An adverse event was defined as any untoward medical event that does not necessarily have a causal relationship to the study device or protocol. Conditions or diseases that were pre-existing and/or chronic but stable were not recorded as adverse events. Similarly, changes in a pre-existing and/or chronic condition or disease that were consistent with natural progression were not recorded as adverse events.

Other adverse events

Adverse event data not reported

Additional Information

Sr. Clinical Trial Lead, CDMA Surgical

Alcon Research, LLC

Phone: 1-888-451-3937

Email: alcon.medinfo@alcon.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
• Publication restrictions are in place

Restriction type: OTHER