Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000708358
Ethics application status
Approved
Date submitted
4/05/2017
Date registered
17/05/2017
Date last updated
29/08/2019
Date data sharing statement initially provided
29/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
CLinical Evaluation of the FluidVision Mongoose X Accommodating Intraocular Lens for Accommodation Restoration
Scientific title
Clinical Evaluation of the FluidVision Mongoose X Accommodating Intraocular Lens for Accommodation Restoration in Adults with Cataract
Secondary ID [1] 291777 0
Powervision, CTP 08239
Universal Trial Number (UTN)
U1111-1192-5993
Trial acronym
CLEAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract 303070 0
Condition category
Condition code
Eye 302528 302528 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this investigation is to compare the safety and effectiveness of the investigational AIOL to the approved commercially available trifocal IOL (Alcon PanOptix IQ) (active control) in patients undergoing bilateral cataract extraction and bilateral intraocular lens implantation.

Patients diagnosed with cataracts in both eyes, who require bilateral cataract extraction by phacoemulsification and are eligible for bilateral IOL implantation.

The study is a prospective, randomized, controlled, bilateral, multinational, subject and assessor-blinded design. The randomization employs a 1:1 ratio for subjects to receive either the investigational AIOL or a commercially available trifocal IOL (Alcon PanOptix IQ) (active control).

Subjects will be randomly assigned to receive bilateral implantation of the Acrysof® IQ PanOptix Trifocal IOL (Model TFNT00, Alcon, TX, USA) with an Alcon qualified delivery system or the investigational FluidVision MX AIOL (PowerVision, CA, USA) using the PowerJect Injector System following standard cataract extraction.

The trifocal lens (Alcon PanOptix IQ) restores vision at more than one distance, by splitting or stretching the light entering the eye. The investigational AIOL is designed to use the eye’s natural forces to change the shape and power of the lens, producing a change in lens power when needed.

Randomization will be stratified by site and both arms of the study will enrol the same number of subjects.

Eligible subjects must be able to undergo the second eye surgery using the same device as the first eye treatment.

The second surgery will occur after the 1 Week follow up on the first eye surgery is complete. Subjects will be followed at 1 day, 1 week, and 1, 3, 6, and 12 months post-surgery.

The intervention is intended to be a single visit outpatient surgery with follow-up visits, also at the the study’s affiliated clinic(s), at 1 day, 1 week, 1 month, 3, 6, and 12 months post-surgery, for each treated eye.

The study team member assigned to perform visual acuity assessments at each follow-up visit will be masked to the type of IOL that the subject receives.

The subject will also be masked to the type of IOL implant used during surgery. The implanting investigator performing the procedure will not be masked to the treatment assignment.
Intervention code [1] 297938 0
Treatment: Devices
Comparator / control treatment
The study is a prospective, randomized, controlled, bilateral, multinational, subject and assessor-blinded design. The randomization employs a 1:1 ratio for subjects to receive either the investigational AIOL or a commercially available trifocal IOL (Alcon PanOptix IQ) (active control)
Control group
Active

Outcomes
Primary outcome [1] 301982 0
Primary effectiveness objective for FluidVision lens will be assessed by comparison of, Monocular distance corrected near visual acuity (DCNVA) at 40 cm between FluidVision lens and trifocal control lens (Alcon PanOptix IQ) at 100% contrast as assessed with the M&S Technologies Clinical Trial Suite System (electronic ETDRS charts).
Timepoint [1] 301982 0
Month 6
Secondary outcome [1] 334435 0
Secondary effectiveness objectives for FluidVision lens will be assessed by comparison of, monocular distance corrected intermediate visual acuity (DCIVA) at 66 cm between FluidVision lens and trifocal control lens (Alcon PanOptix IQ) at 100% contrast as assessed with the M&S Technologies Clinical Trial Suite System (electronic ETDRS charts).
Timepoint [1] 334435 0
Month 6
Secondary outcome [2] 334436 0
Secondary effectiveness objectives for FluidVision lens will be assessed by comparison of, low contrast (10%) monocular distance corrected intermediate visual acuity (DCIVA) at 66 cm between FluidVision lens and trifocal control lens (Alcon PanOptix IQ) at 10% contrast as assessed with the M&S Technologies Clinical Trial Suite System (electronic ETDRS charts).
Timepoint [2] 334436 0
Month 6
Secondary outcome [3] 334437 0
Secondary effectiveness objectives for FluidVision lens will be assessed by comparison of, low contrast (25%) monocular distance corrected intermediate visual acuity (DCIVA) at 66 cm between FluidVision lens and trifocal control lens (Alcon PanOptix IQ) at 25% as assessed with the M&S Technologies Clinical Trial Suite System (electronic ETDRS charts).
Timepoint [3] 334437 0
Month 6
Secondary outcome [4] 334438 0
Secondary effectiveness objectives for FluidVision lens will be assessed by comparison of, low contrast (10%) monocular distance corrected near visual acuity (DCNVA) at 40 cm between FluidVision lens and trifocal control lens (Alcon PanOptix IQ) at 10% as assessed with the M&S Technologies Clinical Trial Suite System (electronic ETDRS charts).
Timepoint [4] 334438 0
Month 6
Secondary outcome [5] 334439 0
Secondary effectiveness objectives for FluidVision lens assessed by comparison of, low contrast (25%) monocular distance corrected near visual acuity (DCNVA) at 40 cm between FluidVision lens and trifocal control lens (Alcon PanOptix IQ) 25% as assessed with the M&S Technologies Clinical Trial Suite System (electronic ETDRS charts).
Timepoint [5] 334439 0
Month 6
Secondary outcome [6] 334440 0
Secondary effectiveness objectives for FluidVision lens will demonstrate that range of vision between 4 m and 40 cm (binocular, as measured by defocus curve) is comparable to the control lens (comparison between FluidVision lens and trifocal control lens - Alcon PanOptix IQ) as assessed with the M&S Technologies Clinical Trial Suite System (electronic ETDRS)
Timepoint [6] 334440 0
Month 6

Eligibility
Key inclusion criteria
1. At least 50 years of age;
2. Willing and able to comply with schedule for follow-up visits;
3. Able to read and understand the Informed Consent Form and Patient Information materials;
4. Eligible for primary intraocular lens implantation for the correction of aphakia following cataract extraction
5. Corrected distance visual acuity is equal to or worse than 20/40 either with or without a glare source present OR presence of visually significant lens opacity;
6. Predicted corrected distance visual acuity in both eyes to be 20/32 or better after cataract removal and IOL implantation as determined by potential acuity meter (PAM) or other potential vision tests;
7. Less than or equal to 1.0 diopter (D) of preoperative or predicted post-operative corneal astigmatism;
8. Clear intraocular media other than cataract;
9. Preoperative central endothelial cell density of 2200 cells/mm2 or more;
10. Eligible for LASIK procedure or other corneal refraction correction procedure;
11. Willing to wear contact lenses and physically capable of wearing them per
investigator examination
12. Able to undergo second eye surgery within 14 days after the first eye surgery.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject is a member of a vulnerable population as defined in ISO 14155;
2. Current use of medications that may affect accommodation;
3. Current or historic use of systemic medications that may confound the outcome or increase the risk to the subject;
4. Sensitivity to planned study medications;
5. Pregnant, lactating, or has another condition with associated fluctuation of hormones that could lead to refractive changes;
6. Has systemic disease that could increase the operative risk or confound the outcome;
7. Ocular conditions that may predispose for future complications (e.g. anterior segment pathology including potentially occludable angles, corneal dystrophy, ocular inflammation);
8. Monocular patient or significant permanent visual function loss in one eye;
9. Previous refractive, intraocular or corneal surgery in either eye;
10. Diagnosed degenerative visual disorders that are predicted to cause future corrected distance visual acuity worse than 20/32;
11. Conditions that increase the risk of zonular rupture during procedure;
12. Simultaneous participation in other ophthalmic drug or device clinical trial;
13. Baseline dilated pupil size less than 8 mm in diameter;
14. Anterior Chamber Depth (ACD) less than 2.8 mm, based on IOL Master;
15. Grade 4 cataract in either eye, as assessed per the Quick Reference Guide (QRG)-8 published by the American Optometric Association;
16. Subject has any other condition(s), disease(s) or habit(s) that would interfere with completion of the study and follow-up visits, increase the risk(s) of the cataract and/or IOL procedure, or in the physician’s judgement, would interfere with compliance to the study or adversely impact study outcomes.
17. Subject randomized to AIOL with ocular dimensions not within range of manufacturer’s fitting algorithm.

Intraoperative Exclusion Criteria
18. Do not have an intact capsulorhexis and posterior capsule at the time of cataract
extraction and lens implantation;
19. Floppy/weak zonules, incomplete zonules or zonular rupture during cataract
extraction;
20. Posterior capsules that are found to be thin, brittle or fibrosed;
21. Decentered capsulorhexis of >1.0 mm in relation to the limbus;
22. Posterior capsular opacity observed after cataract extraction;
23. Complicated cataract surgery that prevents attempted implantation of the (A)IOL.

Additional Intraoperative Exclusion Criteria for the FluidVision AIOL
24. Unable to attain and maintain a dilated pupil size =7 mm in diameter;
25. Capsulorhexis size of less than 6.0 mm or greater than 6.5 mm.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocated unmasked study staff member will perform the paper-randomization process, without masked study staff present. The Randomisation Envelopes (REs) with lowest number on top must be used in sequence: 1 through 30. The REs are sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study is a prospective, randomized, controlled, bilateral, multinational, subject and assessor-blinded design. The randomization employs a 1:1 ratio for subjects to receive either the investigational AIOL or a commercially available trifocal IOL (Alcon PanOptix IQ) (active control).
Randomization will be sequence generated using a randomisation table created by computer software (ie computerised sequence generation and stratified by site). Both arms of the study will enrol the same number of subjects.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Enrollment
A maximum of 90 subjects will be enrolled. Forty-five (45) subjects will be assigned to each
cohort to allow for 40 evaluable subjects in each cohort.
Each study site is expected to enroll a minimum of 4 and a maximum of 22 subjects

Investigational Site Locations
Up to 15 clinical sites in up to 6 countries: Australia, New Zealand, South Africa, El Salvador, Canada, and the United Kingdom.

All subjects in whom an implant of either type is attempted (defined as insertion of cartridge tip into cornea with intent to implant a trifocal IOL (Alcon PanOptix IQ) or FluidVision MX AIOL) will be followed for the duration of the study, whether the assigned lens is successfully implanted or not.

Based on the subject biometry, the sponsor will assign each subject a lens that is best suited for the subject to provide optimal results for them.

Each interventional treatment provider will be required to complete an in-person hands on implant/explant training session and and will be provided an Instructions for Use document prior to implanting any device at their affiliated clinic/hospital. In addition, each procedure will be attended by a Sponsor-appointed proctor.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Additional detail regarding data analysis is in the study’s Statistical Analysis Plan.
The proposed sample size (N = 40 evaluable per arm) will provide 80% power for the non-inferiority
hypothesis with respect to mean monocular DCNVA when tested at the 0.05 level of significance (one sided)with a non-inferiority margin of 0.10 logMAR assuming the difference in means is 0.0 logMAR (SD =0.18).

Data analysis will be completed for the following categories
A. Analyses Population
B. Subject Accountability
C. Demographics and Baseline characteristics
D. Interim Analyses
The primary analysis of primary and secondary effectiveness endpoints will be based on results from the 6 Month visit, except Rotational Stability which will be analyzed at the 3 Month visit. No interim analyses for the purposes of early stopping for benefit or modifications to the protocol are planned. Safety analysis of ISO-defined adverse events and rate of device deficiencies will be assessed at 6 Months and 12 Months.
Analyses of Primary Effectiveness Endpoint
1. Monocular Distance Corrected Near Visual Acuity at 40 cm at 100% contrast
Analyses of Secondary Effectiveness Endpoints
1. Monocular Distance Corrected Intermediate Visual Acuity at 66 cm at 100% contrast
2. Monocular Distance Corrected Intermediate Visual Acuity at 66 cm at 10% contrast
3. Monocular Distance Corrected Intermediate Visual Acuity at 66 cm at 25% contrast
4. Monocular Distance Corrected Near Visual Acuity 40 cm at 10% contrast
5. Monocular Distance Corrected Near Visual Acuity at 40 cm at 25% contrast
6. Range of vision between 4 m and 40 cm with the FluidVision lens (binocular, as measured by defocus curve testing)
Analysis of Safety Endpoints
1. Adverse Events and Device Deficiencies
2. Safety on the implantation procedure as defined by change in endothelial cell count
3. Evaluate contrast sensitivity
Descriptive summaries (counts and percentages) for ISO-defined and specific Anticipated Ocular AEs will be presented by IOL group.

Incidence rates observed for each IOL group will be compared to the ISO-defined cumulative (adverse events which occurred at any time during the investigation) and persistent (adverse events which are present at the 6 Month and 12 Month visit) adverse event SPE for posterior chamber IOLs using the 1-sided exact 95% lower confidence limit. In addition to SPE rates predefined in ISO 11979-7, the rate of adverse events that may be specifically related to test IOL design features; and any other significant events will be provided. These rates will be accompanied by 1-sided exact 95% lower/upper confidence limits.

The number and percentage of all adverse events will be tabulated with a breakdown by IOL group and implanted eye. A listing of all ocular adverse events will also be provided.

The number and percentage of all device deficiencies will be tabulated with a breakdown by IOL group and implanted eye. A listing of all device deficiencies will also be provided.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2017
Actual
27/02/2018
Date of last participant enrolment
Anticipated
Actual
14/11/2018
Date of last data collection
Anticipated
11/12/2019
Actual
Sample size
Target
90
Accrual to date
Final
96
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14658 0
Peninsula Eye Centre - Mornington
Recruitment hospital [2] 14659 0
Armadale Eye Clinic - Armadale
Recruitment hospital [3] 14660 0
Vision Eye Institute, Footscray - Footscray
Recruitment postcode(s) [1] 27687 0
3931 - Mornington
Recruitment postcode(s) [2] 27688 0
3143 - Armadale
Recruitment postcode(s) [3] 27689 0
3011 - Footscray
Recruitment outside Australia
Country [1] 8871 0
New Zealand
State/province [1] 8871 0
Country [2] 8889 0
South Africa
State/province [2] 8889 0
Country [3] 21815 0
Canada
State/province [3] 21815 0
Country [4] 21816 0
El Salvador
State/province [4] 21816 0

Funding & Sponsors
Funding source category [1] 296282 0
Commercial sector/Industry
Name [1] 296282 0
PowerVision, Inc.
Country [1] 296282 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
PowerVision
Address
298 Harbor Blvd
Belmont, CA 94002
Country
United States of America
Secondary sponsor category [1] 295202 0
None
Name [1] 295202 0
Address [1] 295202 0
Country [1] 295202 0
Other collaborator category [1] 280927 0
Commercial sector/Industry
Name [1] 280927 0
Alcon Laboratories
Address [1] 280927 0
6201 South Fwy, Fort Worth, TX 76134, USA
Country [1] 280927 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297515 0
Health and Disability Ethics Committee
Ethics committee address [1] 297515 0
Ethics committee country [1] 297515 0
New Zealand
Date submitted for ethics approval [1] 297515 0
01/02/2017
Approval date [1] 297515 0
03/04/2017
Ethics approval number [1] 297515 0
Ethics committee name [2] 297581 0
Bellberry Limited
Ethics committee address [2] 297581 0
Ethics committee country [2] 297581 0
Australia
Date submitted for ethics approval [2] 297581 0
10/03/2017
Approval date [2] 297581 0
15/02/2018
Ethics approval number [2] 297581 0
Ethics committee name [3] 304202 0
National Ethics Committee for Health Research (CNEIS) El Salvador
Ethics committee address [3] 304202 0
Ethics committee country [3] 304202 0
El Salvador
Date submitted for ethics approval [3] 304202 0
18/12/2017
Approval date [3] 304202 0
21/02/2018
Ethics approval number [3] 304202 0
Please contact sponsor for details
Ethics committee name [4] 304203 0
South African Medical Association Research Ethics Committee (SAMARC)
Ethics committee address [4] 304203 0
Ethics committee country [4] 304203 0
South Africa
Date submitted for ethics approval [4] 304203 0
04/01/2017
Approval date [4] 304203 0
30/03/2017
Ethics approval number [4] 304203 0
Please contact sponsor for details
Ethics committee name [5] 304204 0
Military Hospital Ethics Committee
Ethics committee address [5] 304204 0
Ethics committee country [5] 304204 0
South Africa
Date submitted for ethics approval [5] 304204 0
04/01/2017
Approval date [5] 304204 0
30/03/2017
Ethics approval number [5] 304204 0
Please contact sponsor for details
Ethics committee name [6] 304205 0
Veritas Independent Review Board (IRB), Canada
Ethics committee address [6] 304205 0
Ethics committee country [6] 304205 0
Canada
Date submitted for ethics approval [6] 304205 0
20/02/2018
Approval date [6] 304205 0
04/05/2018
Ethics approval number [6] 304205 0
Please contact sponsor for details

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74286 0
Dr Richard Wolfe
Address 74286 0
Peninsula Eye Centre, 937 Nepean Highway, Mornington, VIC 3931
Country 74286 0
Australia
Phone 74286 0
+61 3 5975 9999
Fax 74286 0
Email 74286 0
[email protected]
Contact person for public queries
Name 74287 0
Bettina Kohler
Address 74287 0
PowerVision
298 Harbor Boulevard
Belmont, CA 94002
Country 74287 0
United States of America
Phone 74287 0
+1 6506209948
Fax 74287 0
+1 6506204607
Email 74287 0
[email protected]
Contact person for scientific queries
Name 74288 0
Bettina Kohler
Address 74288 0
PowerVision
298 Harbor Boulevard
Belmont, CA 94002
Country 74288 0
United States of America
Phone 74288 0
+1 6506209948
Fax 74288 0
Email 74288 0
[email protected]

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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.