Evaluation of the Safety and Performance of the HARMONI® Toric Lens

• Sponsor: ClarVista Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03050697
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arm: 1
• Actual Duration (Months): 10
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

The purpose of this study was to evaluate the safety and effectiveness of the HARMONI® Modular Intraocular Lens System with a toric optic (HMTIOL) in subjects with pre-existing corneal astigmatism in need of cataract surgery.

Condition or Disease	Intervention/Treatment	Phase
Aphakia; Corneal Astigmatism; Cataract	Device: HARMONI® Modular Toric Intraocular Lens; Procedure: Cataract extraction with intraocular lens (IOL) implantation	N/A

Detailed Description

Subjects with visually significant bilateral cataracts (cortical, nuclear, posterior subcapsular, or a combination) were implanted unilaterally (in one eye only) or bilaterally (in both eyes) with the HMTIOL. A total of 7 study visits were planned, including a preoperative visit, operative visits for each eye, and 4 follow-up visits at 1 day, 1 week, 1 month, and 3 months postoperative. The total duration of participation for each subject was up to 6 months, including the preoperative period (up to 3 months).

Alcon Research, LLC, acquired ClarVista Medical in 2017. This study was designed and conducted by ClarVista Medical, Inc. The study results were collected, analyzed, and provided by ClarVista Medical, Inc. to Alcon Research, LLC.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Multicenter Study to Evaluate the Safety and Performance of the Exchangeable ClarVista HARMONI Modular Toric Intraocular Lens System for the Treatment of Pre-Existing Corneal Astigmatism and Aphakia Following Cataract Surgery
• Actual Study Start Date: Sep 28, 2016
• Actual Primary Completion Date: Jun 7, 2017
• Actual Study Completion Date: Jul 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HMTIOL HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use	Device: HARMONI® Modular Toric Intraocular Lens; Two-component system consisting of a base and a separate toric optic; Other Names: HMTIOL ; Procedure: Cataract extraction with intraocular lens (IOL) implantation; Cataract removal via manual phacoemulsification, followed by HMTIOL implantation

Outcome Measures

Primary Outcome Measures

1. Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL [Month 1 postoperative, Month 3 postoperative]

   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.

2. Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL [Month 1 postoperative, Month 3 postoperative]

   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.

3. MRCYL PE for Eyes Implanted With HMTIOL Per Vector Analyses [Month 1 postoperative, Month 3 postoperative]

   Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL PE is 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.

4. Mean Reduction in Cylinder Power for Eyes Implanted With HMTIOL [Baseline (Day 0 preoperative), Month 3 postoperative]

   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.

5. Mean Percent Reduction in Cylinder Power for Eyes Implanted With HMTIOL [Baseline (Day 0 preoperative), Month 3 postoperative]

   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.

6. Mean Manifest Refraction Spherical Equivalent (MRSE) Prediction Error (PE) [Month 1 postoperative, Month 3 postoperative]

   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.

7. Mean Absolute Misalignment of IOL Meridian - Target Versus Actual at Operative Visit [Day 0 (operative)]

   Absolute misalignment of IOL meridian was defined as the summation of IOL misplacement and IOL rotation. A lower number indicates minimal IOL misalignment. No formal statistical hypothesis testing was planned.

8. Mean Absolute Rotation of IOL Meridian by Visit [Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative]

   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. No formal statistical hypothesis testing was planned.

9. Number of Eyes With Absolute Rotation of IOL Meridian by Visit [Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative]

   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.

10. Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit [Baseline (Day 0 preoperative), Week 1 postoperative, Month 1 postoperative, Month 3 postoperative]

    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.

11. Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit [Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative]

    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). 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.

12. Standard Error of the Mean in Lens Power A-constant for Refinement [Day 0 operative]

    The A-constant (lens power constant) is a theoretical value that is used to calculate the power of the intraocular lens. It relates the lens power to the eye's axial length and keratometry. It is not expressed in units; it is specific to the design of the IOL and its intended location and orientation within the eye. A-constants are typically empirically developed for new IOLs based on hundreds of clinical uses. Data from a sufficient number of eyes are needed in order to reduce bias due to surgical technique, unusual eyes, and differences in equipment, such that the standard error of the mean in the lens power constant would be less than ±0.10 mm (approximately ±0.2 diopter). This study represented the first clinical use of the HMTIOL.

13. Number of Ocular Adverse Events Through Month 3 [Up to Month 3 postoperative]

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

14. Number of Device-Related Secondary Surgical Interventions (SSI) Other Than Optic Exchange and Rotational Adjustment of the HMTIOL [Up to Month 3 postoperative]

    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.

15. Number of Device Deficiencies Post Implantation [Up to Month 3 postoperative]

    A device deficiency 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.

16. Number of Eyes With Preservation of Best Corrected Distance Visual Acuity (BCDVA) at Month 1 and Month 3 [Month 1 postoperative, Month 3 postoperative]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

• Planned removal of visually significant bilateral cataract by manual phacoemulsification cataract extraction

• Pre-existing corneal astigmatism in at least 1 eye of 0.75 to 2.50 diopter (D)

• Target dioptric lens power within the range of 16 - 26 D

• Willing to discontinue contact lens wear for the duration of the study

• BCVA projected to be ≤0.2 logarithm minimum angle of resolution (LogMAR)

• Stable cornea

• Dilated pupil size at least 7.0 millimeters (mm)

• Able to understand and provide informed consent.

Key Exclusion Criteria:

• History of any intraocular or corneal surgery in study eye (including refractive)

• Pregnant or lactating

• History of any clinically significant retinal pathology or ocular diagnosis in study eye that could alter or limit final postoperative visual prognosis

• History of ocular conditions which could affect the stability of the IOL in study eye

• Any anterior segment pathology likely to increase the risk of complications from phacoemulsification cataract extraction in study eye

• Any visually significant intraocular media opacity other than cataract in study eye

• Uncontrolled glaucoma in study eye

• Uncontrolled systemic disease

• Severe dry eye that would impair the ability to obtain reliable study measurements

• Systemic medication that may confound the outcome or increase the intraoperative and postoperative risk to the subject.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ClarVista Investigative Site	Auckland		New Zealand	99311

Sponsors and Collaborators

• ClarVista Medical

Investigators

• Study Director: Sr. Clinical Trial Lead, CDMA Surgical, Alcon Research, LLC

Study Documents (Full-Text)

• Study Protocol - Jun 6, 2016
• Statistical Analysis Plan - Jun 29, 2017

More Information

Publications

None provided.

• Responsible Party: ClarVista Medical
• ClinicalTrials.gov Identifier: NCT03050697
• Other Study ID Numbers: CP-00004
• First Posted: Feb 13, 2017
• Last Update Posted: Jun 12, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by ClarVista Medical: Toric; Intraocular lens
• Additional relevant MeSH terms: Cataract; Astigmatism; Aphakia

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from one investigative site located in New Zealand.
Pre-assignment Detail	Of the 16 subjects (25 eyes) enrolled in the study, 4 subjects (7 eyes) were exited prior to implantation as screen failures, and 1 eye in 1 subject was exited prior to implantation due to a medical condition. This reporting group includes all implanted subjects (12) and eyes (17).

Arm/Group Title	HMTIOL
Arm/Group Description	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
Period Title: Overall Study
STARTED	12
COMPLETED	12
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	HMTIOL
Arm/Group Description	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
Overall Participants	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.7 (11.7)
Sex: Female, Male (Count of Participants)
Female	6 50%
Male	6 50%
Race/Ethnicity, Customized (Count of Participants)
Asian	0 0%
Black	0 0%
Caucasian	10 83.3%
Other	2 16.7%
Region of Enrollment (participants) [Number]
New Zealand	12 100%

Outcome Measures

1. Primary Outcome

Title	Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL
Description	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.
Time Frame	Month 1 postoperative, Month 3 postoperative

Outcome Measure Data

Analysis Population Description

Implanted Eye: All eyes with successful HMTIOL implantation and data at visit

Arm/Group Title	HMTIOL
Arm/Group Description	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
Measure Participants	12
Measure eyes	17
Month 1 postoperative	-0.50 (0.95)
Month 3 postoperative	-0.57 (0.98)

2. Primary Outcome

Title	Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL
Description	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.
Time Frame	Month 1 postoperative, Month 3 postoperative

Outcome Measure Data

Analysis Population Description

Implanted Eye: All eyes with successful HMTIOL implantation and data at visit

Arm/Group Title	HMTIOL
Arm/Group Description	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
Measure Participants	12
Measure eyes	17
Month 1 postoperative	0.01 (0.26)
Month 3 postoperative	-0.03 (0.29)

3. Primary Outcome

Title	MRCYL PE for Eyes Implanted With HMTIOL Per Vector Analyses
Description	Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL PE is 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.
Time Frame	Month 1 postoperative, Month 3 postoperative

Outcome Measure Data

Analysis Population Description

Vector analyses (Eydelman 2006) based on the cylinder power and axis were planned but were not performed.

Arm/Group Title	HMTIOL
Arm/Group Description	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
Measure Participants	0

4. Primary Outcome

Title	Mean Reduction in Cylinder Power for Eyes Implanted With HMTIOL
Description	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.
Time Frame	Baseline (Day 0 preoperative), Month 3 postoperative

Outcome Measure Data

Analysis Population Description

Implanted Eye: All eyes with successful HMTIOL implantation and data at visit

Arm/Group Title	HMTIOL
Arm/Group Description	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
Measure Participants	12
Measure eyes	17
Mean (Standard Deviation) [diopter]	1.15 (0.63)

5. Primary Outcome

Title	Mean Percent Reduction in Cylinder Power for Eyes Implanted With HMTIOL
Description	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.
Time Frame	Baseline (Day 0 preoperative), Month 3 postoperative

Outcome Measure Data

Analysis Population Description

Implanted Eye: All eyes with successful HMTIOL implantation and data at visit

Arm/Group Title	HMTIOL
Arm/Group Description	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
Measure Participants	12
Measure eyes	17
Mean (Standard Deviation) [percent reduction]	76.2 (27.4)

6. Primary Outcome

Title	Mean Manifest Refraction Spherical Equivalent (MRSE) Prediction Error (PE)
Description	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.
Time Frame	Month 1 postoperative, Month 3 postoperative

Outcome Measure Data

Analysis Population Description

Implanted Eye: All eyes with successful HMTIOL implantation and data at visit

Arm/Group Title	HMTIOL
Arm/Group Description	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
Measure Participants	12
Measure eyes	17
Month 1 postoperative	0.14 (0.41)
Month 3 postoperative	0.26 (0.43)

7. Primary Outcome

Title	Mean Absolute Misalignment of IOL Meridian - Target Versus Actual at Operative Visit
Description	Absolute misalignment of IOL meridian was defined as the summation of IOL misplacement and IOL rotation. A lower number indicates minimal IOL misalignment. No formal statistical hypothesis testing was planned.
Time Frame	Day 0 (operative)

Outcome Measure Data

Analysis Population Description

Implanted Eye: All eyes with successful HMTIOL implantation and data at visit

Arm/Group Title	HMTIOL
Arm/Group Description	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
Measure Participants	12
Measure eyes	17
Mean (Standard Deviation) [degrees]	2.6 (1.7)

8. Primary Outcome

Title	Mean Absolute Rotation of IOL Meridian by Visit
Description	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. No formal statistical hypothesis testing was planned.
Time Frame	Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative

Outcome Measure Data

Analysis Population Description

Implanted Eye: All eyes with successful HMTIOL implantation and data at visit

Arm/Group Title	HMTIOL - Day 1 Postoperative
Arm/Group Description	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
Measure Participants	12
Measure eyes	13
Rotation from operative to Day 1 postoperative	1.9 (1.8)
Rotation from operative to Week 1 postoperative	2.3 (1.6)
Rotation from operative to Month 1 postoperative	2.9 (2.2)
Rotation from operative to Month 3 postoperative	2.4 (2.3)

9. Primary Outcome

Title	Number of Eyes With Absolute Rotation of IOL Meridian by Visit
Description	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.
Time Frame	Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative

Outcome Measure Data

Analysis Population Description

Implanted Eye: All eyes with successful HMTIOL implantation and data at visit. Analysis of IOL rotation was planned for rotation categories of ≤ 5°, < 10°, < 20°, and < 30°. Instead, IOL rotation was reported for categories of ≤ 5°, > 5° to ≤ 10°, > 10° to ≤ 20°, and > 20°.

Arm/Group Title	HMTIOL - Day 1 Postoperative	HMTIOL - Week 1 Postoperative	HMTIOL - Month 1 Postoperative	HMTIOL - Month 3 Postoperative
Arm/Group Description	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
Measure Participants	12	12	12	12
Measure eyes	13	13	13	13
Rotation from operative ≤ 5 degrees	12	12	12	12
Rotation from operative > 5 to ≤ 10 degrees	1	1	1	1
Rotation from operative > 10 to ≤ 20 degrees	0	0	0	0
Rotation from operative > 20 degrees	0	0	0	0

10. Primary Outcome

Title	Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit
Description	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.
Time Frame	Baseline (Day 0 preoperative), Week 1 postoperative, Month 1 postoperative, Month 3 postoperative

Outcome Measure Data

Analysis Population Description

Implanted Eye: All eyes with successful HMTIOL implantation and data at visit

Arm/Group Title	HMTIOL - Baseline (Day 0 Preoperative)	HMTIOL - Week 1 Postoperative	HMTIOL - Month 1 Postoperative	HMTIOL - Month 3 Postoperative
Arm/Group Description	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
Measure Participants	12	12	12	12
Measure eyes	17	17	17	17
20/20 Snellen or Better	35.3	82.4	82.4	88.2
20/25 Snellen or Better	47.1	88.2	94.1	88.2
20/32 Snellen or Better	64.7	88.2	94.1	100.0
20/40 Snellen or Better	64.7	94.1	94.1	100.0
Worse than 20/40 Snellen	35.3	5.9	5.9	0.0

11. Primary Outcome

Title	Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit
Description	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). 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.
Time Frame	Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative

Outcome Measure Data

Analysis Population Description

Implanted Eye: All eyes with successful HMTIOL implantation and data at visit

Arm/Group Title	HMTIOL - Baseline (Day 0 Preoperative)	HMTIOL - Day 1 Postoperative	HMTIOL - Week 1 Postoperative	HMTIOL - Month 1 Postoperative	HMTIOL - Month 3 Postoperative
Arm/Group Description	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
Measure Participants	12	12	12	12	12
Measure eyes	17	17	17	17	17
20/20 Snellen or Better	0.0	23.5	52.9	47.1	52.9
20/25 Snellen or Better	5.9	35.3	76.5	70.6	76.5
20/32 Snellen or Better	35.3	70.6	76.5	76.5	76.5
20/40 Snellen or Better	47.1	82.4	88.2	88.2	88.2
Worse than 20/40 Snellen	52.9	17.6	11.8	11.8	11.8

12. Primary Outcome

Title	Standard Error of the Mean in Lens Power A-constant for Refinement
Description	The A-constant (lens power constant) is a theoretical value that is used to calculate the power of the intraocular lens. It relates the lens power to the eye's axial length and keratometry. It is not expressed in units; it is specific to the design of the IOL and its intended location and orientation within the eye. A-constants are typically empirically developed for new IOLs based on hundreds of clinical uses. Data from a sufficient number of eyes are needed in order to reduce bias due to surgical technique, unusual eyes, and differences in equipment, such that the standard error of the mean in the lens power constant would be less than ±0.10 mm (approximately ±0.2 diopter). This study represented the first clinical use of the HMTIOL.
Time Frame	Day 0 operative

Outcome Measure Data

Analysis Population Description

The planned sample size of 200 eyes was calculated based on the planned refinement of the A-Constant; however, due to the change in the study design, a sample size of 30 was targeted and a total of 17 eyes were implanted. Refinement of the A-Constant was planned, but not completed, due to the change in study design. No data was collected.

Arm/Group Title	HMTIOL
Arm/Group Description	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
Measure Participants	0

13. Primary Outcome

Title	Number of Ocular Adverse Events Through Month 3
Description	Ocular adverse events were identified as outlined in ISO 11979-2014 Annex B. No formal statistical hypothesis testing was planned.
Time Frame	Up to Month 3 postoperative

Outcome Measure Data

Analysis Population Description

Safety Analysis: All eyes with attempted study lens implantation (successful or aborted after contact with the eye)

Arm/Group Title	HMTIOL
Arm/Group Description	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
Measure Participants	12
Measure eyes	17
Astigmatism	1
Ciliary zonular dehiscence	1
Intraocular injection	1
Macular oedema	1
Vitrectomy	1

14. Primary Outcome

Title	Number of Device-Related Secondary Surgical Interventions (SSI) Other Than Optic Exchange and Rotational Adjustment of the HMTIOL
Description	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.
Time Frame	Up to Month 3 postoperative

Outcome Measure Data

Analysis Population Description

Safety Analysis: All eyes with attempted study lens implantation (successful or aborted after contact with the eye)

Arm/Group Title	HMTIOL
Arm/Group Description	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
Measure Participants	12
Measure eyes	17
Number [SSI]	1

15. Primary Outcome

Title	Number of Device Deficiencies Post Implantation
Description	A device deficiency 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.
Time Frame	Up to Month 3 postoperative

Outcome Measure Data

Analysis Population Description

Safety Analysis: All eyes with attempted study lens implantation (successful or aborted after contact with the eye)

Arm/Group Title	HMTIOL
Arm/Group Description	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
Measure Participants	12
Measure eyes	17
Number [device deficiency]	0

16. Primary Outcome

Title	Number of Eyes With Preservation of Best Corrected Distance Visual Acuity (BCDVA) at Month 1 and Month 3
Description	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.
Time Frame	Month 1 postoperative, Month 3 postoperative

Outcome Measure Data

Analysis Population Description

Safety Analysis: All eyes with attempted study lens implantation (successful or aborted after contact with the eye)

Arm/Group Title	HMTIOL - Month 1 Postoperative	HMTIOL - Month 3 Postoperative
Arm/Group Description	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use	HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
Measure Participants	12	12
Measure eyes	17	17
Loss < 1 line	16	16
Loss >= 1 line	1	1
Loss >= 2 lines	0	0
Loss >= 3 lines	0	0
Loss >= 4 lines	0	0

Adverse Events

Time Frame	Adverse events were collected from time of consent until study exit (up to 6 months).
Adverse Event Reporting Description	An adverse event was defined as any untoward medical event that does not necessarily have a causal relationship to the study device or protocol. "At Risk" population for ocular adverse events is reported with unit of eye.
Arm/Group Title	HMTIOL - Nonocular AEs		HMTIOL - Ocular AEs
Arm/Group Description	All subjects with attempted study lens implantation (successful or aborted after contact with the eye)		All eyes with attempted study lens implantation (successful or aborted after contact with the eye)
All Cause Mortality
	HMTIOL - Nonocular AEs		HMTIOL - Ocular AEs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/17 (0%)
Serious Adverse Events
	HMTIOL - Nonocular AEs		HMTIOL - Ocular AEs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	HMTIOL - Nonocular AEs		HMTIOL - Ocular AEs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		2/17 (11.8%)
Eye disorders
Astigmatism	0/12 (0%)		1/17 (5.9%)
Macular oedema	0/12 (0%)		1/17 (5.9%)
Injury, poisoning and procedural complications
Procedural complication	0/12 (0%)		1/17 (5.9%)
Surgical and medical procedures
Intra-ocular injection	0/12 (0%)		1/17 (5.9%)
Vitrectomy	0/12 (0%)		1/17 (5.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.