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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03050697




Registration number
NCT03050697
Ethics application status
Date submitted
14/09/2016
Date registered
13/02/2017
Date last updated
12/06/2020

Titles & IDs
Public title
Evaluation of the Safety and Performance of the HARMONI® Toric Lens
Scientific 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
Secondary ID [1] 0 0
CP-00004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aphakia 0 0
Corneal Astigmatism 0 0
Cataract 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - HARMONI® Modular Toric Intraocular Lens
Treatment: Surgery - Cataract extraction with intraocular lens (IOL) implantation

Experimental: HMTIOL - HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use


Treatment: Devices: HARMONI® Modular Toric Intraocular Lens
Two-component system consisting of a base and a separate toric optic

Treatment: Surgery: Cataract extraction with intraocular lens (IOL) implantation
Cataract removal via manual phacoemulsification, followed by HMTIOL implantation
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL
Timepoint [1] 0 0
Month 1 postoperative, Month 3 postoperative
Primary outcome [2] 0 0
Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL
Timepoint [2] 0 0
Month 1 postoperative, Month 3 postoperative
Primary outcome [3] 0 0
MRCYL PE for Eyes Implanted With HMTIOL Per Vector Analyses
Timepoint [3] 0 0
Month 1 postoperative, Month 3 postoperative
Primary outcome [4] 0 0
Mean Reduction in Cylinder Power for Eyes Implanted With HMTIOL
Timepoint [4] 0 0
Baseline (Day 0 preoperative), Month 3 postoperative
Primary outcome [5] 0 0
Mean Percent Reduction in Cylinder Power for Eyes Implanted With HMTIOL
Timepoint [5] 0 0
Baseline (Day 0 preoperative), Month 3 postoperative
Primary outcome [6] 0 0
Mean Manifest Refraction Spherical Equivalent (MRSE) Prediction Error (PE)
Timepoint [6] 0 0
Month 1 postoperative, Month 3 postoperative
Primary outcome [7] 0 0
Mean Absolute Misalignment of IOL Meridian - Target Versus Actual at Operative Visit
Timepoint [7] 0 0
Day 0 (operative)
Primary outcome [8] 0 0
Mean Absolute Rotation of IOL Meridian by Visit
Timepoint [8] 0 0
Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
Primary outcome [9] 0 0
Number of Eyes With Absolute Rotation of IOL Meridian by Visit
Timepoint [9] 0 0
Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
Primary outcome [10] 0 0
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit
Timepoint [10] 0 0
Baseline (Day 0 preoperative), Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
Primary outcome [11] 0 0
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit
Timepoint [11] 0 0
Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
Primary outcome [12] 0 0
Standard Error of the Mean in Lens Power A-constant for Refinement
Timepoint [12] 0 0
Day 0 operative
Primary outcome [13] 0 0
Number of Ocular Adverse Events Through Month 3
Timepoint [13] 0 0
Up to Month 3 postoperative
Primary outcome [14] 0 0
Number of Device-Related Secondary Surgical Interventions (SSI) Other Than Optic Exchange and Rotational Adjustment of the HMTIOL
Timepoint [14] 0 0
Up to Month 3 postoperative
Primary outcome [15] 0 0
Number of Device Deficiencies Post Implantation
Timepoint [15] 0 0
Up to Month 3 postoperative
Primary outcome [16] 0 0
Number of Eyes With Preservation of Best Corrected Distance Visual Acuity (BCDVA) at Month 1 and Month 3
Timepoint [16] 0 0
Month 1 postoperative, Month 3 postoperative

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
22 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/09/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/07/2017
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ClarVista Medical
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03050697
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sr. Clinical Trial Lead, CDMA Surgical
Address 0 0
Alcon Research, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries