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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03050697
Ethics application status
Date submitted
14/09/2016
Date registered
13/02/2017

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
Not applicable
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03050697