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

NCT03050697 | Completed Results FDA Device

• 1 other identifier: CP-00004
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphakia; Corneal Astigmatism; Cataract

Keywords

Toric; Intraocular lens

Outcome Measures

Primary Outcomes (16)

• Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL

  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.

  Month 1 postoperative, Month 3 postoperative

• Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL

  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.

  Month 1 postoperative, Month 3 postoperative

• MRCYL PE for Eyes Implanted With HMTIOL Per Vector Analyses

  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.

  Month 1 postoperative, Month 3 postoperative

• Mean Reduction in Cylinder Power for Eyes Implanted With HMTIOL

  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.

  Baseline (Day 0 preoperative), Month 3 postoperative

• Mean Percent Reduction in Cylinder Power for Eyes Implanted With HMTIOL

  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.

  Baseline (Day 0 preoperative), Month 3 postoperative

• Mean Manifest Refraction Spherical Equivalent (MRSE) Prediction Error (PE)

  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.

  Month 1 postoperative, Month 3 postoperative

• Mean Absolute Misalignment of IOL Meridian - Target Versus Actual at Operative Visit

  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.

  Day 0 (operative)

• Mean Absolute Rotation of IOL Meridian by 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. No formal statistical hypothesis testing was planned.

  Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative

• Number of Eyes With Absolute Rotation of IOL Meridian by 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.

  Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative

• Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by 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.

  Baseline (Day 0 preoperative), Week 1 postoperative, Month 1 postoperative, Month 3 postoperative

• Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by 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). 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.

  Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative

• Standard Error of the Mean in Lens Power A-constant for Refinement

  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.

  Day 0 operative

• Number of Ocular Adverse Events Through Month 3

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

  Up to Month 3 postoperative

• Number of Device-Related Secondary Surgical Interventions (SSI) Other Than Optic Exchange and Rotational Adjustment of the HMTIOL

  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.

  Up to Month 3 postoperative

• Number of Device Deficiencies Post Implantation

  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.

  Up to Month 3 postoperative

• Number of Eyes With Preservation of Best Corrected Distance Visual Acuity (BCDVA) at Month 1 and Month 3

  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.

  Month 1 postoperative, Month 3 postoperative

Study Arms (1)

HMTIOL

EXPERIMENTAL

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; Procedure: Cataract extraction with intraocular lens (IOL) implantation

Interventions

HARMONI® Modular Toric Intraocular Lens DEVICE

Two-component system consisting of a base and a separate toric optic

Also known as: HMTIOL

HMTIOL

Cataract extraction with intraocular lens (IOL) implantation PROCEDURE

Cataract removal via manual phacoemulsification, followed by HMTIOL implantation

HMTIOL

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ClarVista Medical: lead

Study Sites (1)

ClarVista Investigative Site

Auckland, 99311, New Zealand

Location

MeSH Terms

Conditions

Aphakia; Astigmatism; Cataract

Interventions

Cataract Extraction; Lenses, Intraocular; Drug Implants

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Lenses; Optical Devices; Equipment and Supplies; Prostheses and Implants; Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Sr. Clinical Trial Lead, CDMA Surgical
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Sr. Clinical Trial Lead, CDMA Surgical

  Alcon Research, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: February 13, 2017
• Study Start: September 28, 2016
• Primary Completion: June 7, 2017
• Study Completion: July 28, 2017
• Last Updated: June 12, 2020
• Results First Posted: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)