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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03010254




Registration number
NCT03010254
Ethics application status
Date submitted
3/01/2017
Date registered
5/01/2017

Titles & IDs
Public title
A Clinical Study of the ACRYSOF® IQ EDF Intraocular Lens (IOL)
Scientific title
A Prospective, Randomized, Controlled, Multi-Center Clinical Study of the ACRYSOF® IQ Extended Depth of Focus (EDF) IOL
Secondary ID [1] 0 0
ILI875-C001
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 - ACRYSOF® IQ Extended Depth of Focus IOL
Treatment: Devices - ACRYSOF® IQ Monofocal IOL
Treatment: Surgery - Cataract surgery

Experimental: DFT015 - ACRYSOF® IQ Extended Depth of Focus Intraocular lens (IOL), bilateral implantation

Active comparator: SN60WF - ACRYSOF® IQ Monofocal IOL, bilateral implantation


Treatment: Devices: ACRYSOF® IQ Extended Depth of Focus IOL
Implantable IOL intending to extend the depth of focus and provide continuous functional vision from distance to near while maintaining distance vision and a visual disturbance profile comparable to a monofocal IOL; intended for long-term use over the lifetime of the pseudophakic subject

Treatment: Devices: ACRYSOF® IQ Monofocal IOL
Monofocal IOL implanted for long-term use over the lifetime of the pseudophakic subject

Treatment: Surgery: Cataract surgery
IOL bilateral 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
Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeters (cm)
Timepoint [1] 0 0
Month 3 (70-100 days post second eye implantation)
Primary outcome [2] 0 0
Percentage of Subjects With Ocular Adverse Events
Timepoint [2] 0 0
Day 0 (first operative eye visit) up to Month 6 (120-180 days post second eye implantation)
Secondary outcome [1] 0 0
Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters (m)
Timepoint [1] 0 0
Month 3 (70-100 days post second eye implantation)
Secondary outcome [2] 0 0
Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm
Timepoint [2] 0 0
Month 3 (70-100 days post second eye implantation)
Secondary outcome [3] 0 0
Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve
Timepoint [3] 0 0
Month 3 (70-100 days post second eye implantation)
Secondary outcome [4] 0 0
Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd)
Timepoint [4] 0 0
Month 6 (120-180 days post second eye implantation)
Secondary outcome [5] 0 0
Percentage of Subjects Who Respond "Never" to Question 1 of the Spectacle Use Questionnaire: "How Often Do You Wear Eyeglasses for Any Purpose?"
Timepoint [5] 0 0
Month 6 (120-180 days post second eye implantation)
Secondary outcome [6] 0 0
Percentage of Subjects Who Respond "Never" to Question 3 of the Spectacle Use Questionnaire: "How Often Do You Wear Eyeglasses for Intermediate Tasks (e.g., Computer)?"
Timepoint [6] 0 0
Month 6 (120-180 days post second eye implantation)

Eligibility
Key inclusion criteria
* Able to understand and sign an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB) approved Informed Consent Form;
* Diagnosed with cataract in both eyes;
* Planned cataract removal by routine small incision surgery;
* Calculated IOL power is within the clinical study supply range (18.0-25.0 diopter (D) in 0.5 D steps);
* Preoperative regular astigmatism of less than 1.0 D.
Minimum age
22 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnancy or lactation current or planned during the course of the study;
* History of anterior segment (corneal, anterior chamber, sulcus) or posterior segment (uveal, vitreo-retinal) pathology including retinal vascular occlusive disease, retinal detachment or peripheral retinal laser photocoagulation, age-related macular degeneration (ARMD), glaucoma (uncontrolled or controlled with medication) or ocular hypertension, diabetic retinopathy, retinitis pigmentosa and any optic nerve pathology.

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)
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 receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
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
21/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/10/2018
Sample size
Target
Accrual to date
Final
322
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Alcon Investigative Site - Sydney
Recruitment hospital [2] 0 0
Alcon Investigative Site - Southport
Recruitment hospital [3] 0 0
Alcon Investigative Site - Footscray
Recruitment hospital [4] 0 0
Alcon Investigative Site - Hawthorn East
Recruitment postcode(s) [1] 0 0
2150 - Sydney
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
3011 - Footscray
Recruitment postcode(s) [4] 0 0
3123 - Hawthorn East
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Canada
State/province [3] 0 0
QU
Country [4] 0 0
Spain
State/province [4] 0 0
BCN
Country [5] 0 0
Spain
State/province [5] 0 0
Cadiz
Country [6] 0 0
Spain
State/province [6] 0 0
Barcelona
Country [7] 0 0
Spain
State/province [7] 0 0
Madrid
Country [8] 0 0
Spain
State/province [8] 0 0
Valencia
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Kent
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Essex
Country [11] 0 0
United Kingdom
State/province [11] 0 0
London
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alcon Research
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Senior Clinical Manager, GCRA
Address 0 0
Alcon Research
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/NCT03010254