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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02521766




Registration number
NCT02521766
Ethics application status
Date submitted
6/08/2015
Date registered
13/08/2015
Date last updated
14/05/2020

Titles & IDs
Public title
A Clinical Investigation of the ClarVista HARMONI™ Modular Intraocular Lens Implant Following Cataract Surgery
Scientific title
A Prospective, Multi-Center, Feasibility Trial of the ClarVista HARMONI™ Modular Intraocular Lens System for the Treatment of Aphakia Following Cataract Surgery
Secondary ID [1] 0 0
CP-00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Harmoni Modular Intraocular Lens
Treatment: Devices - Commercially Available Intraocular Lens
Treatment: Surgery - Optic exchange

Experimental: All HMIOL Cohort - HMIOL implantation with or without optic exchange

Experimental: Cohort 1 - HMIOL implantation with no optic exchange

Experimental: Cohort 2 - HMIOL implantation with optic exchange

Other: Fellow Eye - IOL implantation per standard of care


Treatment: Devices: Harmoni Modular Intraocular Lens
Two-component system consisting of a base and a separate optic that allows for an intraoperative exchange of the optic only without direct manipulation of the capsular bag

Treatment: Devices: Commercially Available Intraocular Lens
IOL per investigator's standard of care

Treatment: Surgery: Optic exchange
Removal of one optic and replacement with another for the purpose of improving refractive outcomes
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
Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - All HMIOL Cohort
Timepoint [1] 0 0
Month 1 postoperative, Month 3 postoperative
Primary outcome [2] 0 0
Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 1
Timepoint [2] 0 0
Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative
Primary outcome [3] 0 0
Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 2
Timepoint [3] 0 0
Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange
Primary outcome [4] 0 0
Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Fellow Eye
Timepoint [4] 0 0
Month 1 postoperative, Month 3 postoperative, Month 12 postoperative
Primary outcome [5] 0 0
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - All HMIOL Cohort
Timepoint [5] 0 0
Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
Primary outcome [6] 0 0
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1
Timepoint [6] 0 0
Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative
Primary outcome [7] 0 0
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2
Timepoint [7] 0 0
Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange
Primary outcome [8] 0 0
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Fellow Eye
Timepoint [8] 0 0
Month 1 postoperative, Month 3 postoperative, Month 12 postoperative
Primary outcome [9] 0 0
Mean BCDVA (Letters Read) by Study Visit - All HMIOL Cohort
Timepoint [9] 0 0
Day -90 to Day -1 preoperative, Month 1 postoperative, Month 3 postoperative
Primary outcome [10] 0 0
Mean BCDVA (Letters Read) by Study Visit - Cohort 1
Timepoint [10] 0 0
Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative
Primary outcome [11] 0 0
Mean BCDVA (Letters Read) by Study Visit - Cohort 2
Timepoint [11] 0 0
Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange
Primary outcome [12] 0 0
Mean BCDVA (Letters Read) by Study Visit - Fellow Eye
Timepoint [12] 0 0
Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Month 12 postoperative
Primary outcome [13] 0 0
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - All HMIOL Cohort
Timepoint [13] 0 0
Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
Primary outcome [14] 0 0
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 1
Timepoint [14] 0 0
Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative
Primary outcome [15] 0 0
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2
Timepoint [15] 0 0
Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Day 1 post-optic exchange, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exch
Primary outcome [16] 0 0
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Fellow Eye
Timepoint [16] 0 0
Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative
Primary outcome [17] 0 0
Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2
Timepoint [17] 0 0
Day 1 post-optic exchange, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange
Primary outcome [18] 0 0
Mesopic Best Corrected Distance Visual Acuity (mBCDVA) (With and Without Glare) (Letters Read) at Study Visit - All HMIOL Cohort
Timepoint [18] 0 0
Month 3 postoperative

Eligibility
Key inclusion criteria
* Must be able to understand and provide informed consent
* Must be willing and able to return for scheduled treatment and follow-up examinations for up to 15 month study duration
* Planned bilateral removal of visually significant bilateral cataracts
* Best-corrected distance visual acuity (BCDVA) projected to be better than 20/32 after IOL implantation in both eyes
* Preoperative bilateral BCDVA of 20/40 or worse
* Both eyes must have corneal astigmatism = 1.50 diopter (D)
* Women must be post-menopausal =1 year or surgically sterilized, or a pregnancy screen must be performed prior to the study and a reliable form of contraception, approved by the investigator, must be maintained during the study
* Dilated pupil size equal to or greater than 6 millimeters (mm) in primary study eye
* Other protocol-specified inclusion criteria may apply.
Minimum age
22 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participation in any other drug or device clinical trial within 30 days prior to enrolling in this study and/or during study participation
* History of any intraocular or corneal surgery in either eye (including refractive)
* History of any clinically significant retinal pathology or ocular diagnosis in either eye
* History of any ocular conditions which could affect the stability of the IOL
* Uncontrolled glaucoma in either eye
* Other protocol-specified exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
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
1/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/10/2017
Sample size
Target
Accrual to date
Final
217
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
Philippines
State/province [2] 0 0
Manila

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

Ethics approval
Ethics application status

Summary
Brief summary
The main objectives of this feasibility study were:

* To demonstrate the feasibility of HARMONI Modular Intraocular Lens (HMIOL) implantation and assembly in subjects undergoing cataract surgery (All HMIOL Cohort), and
* To demonstrate the feasibility of the HMIOL optic component exchange procedure (performed 3 months following primary cataract extraction) (Cohort 2).
Trial website
https://clinicaltrials.gov/study/NCT02521766
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sr. CDMA Project Lead, 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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02521766