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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)
Assessment method [1] 0 0
Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
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
Assessment method [2] 0 0
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular AEs are events localized to the eye. Cumulative and persistent serious adverse events as defined by ISO 11979-7:2014 were collected for Model DFT015 first and second eyes. No formal statistical hypothesis testing was planned.
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)
Assessment method [1] 0 0
VA was tested monocularly under photopic conditions using the correction obtained from the manual manifest refraction and 100% contrast, ETDRS charts at a distance of 4 m from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
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
Assessment method [2] 0 0
VA was tested monocularly under photopic conditions using best distance correction (distance refraction) and high contrast, ETDRS chart set at 40 cm from the spectacle plane using the near point rod. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
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
Assessment method [3] 0 0
Depth of focus was assessed at 4 meters under photopic (well-lit) conditions using best corrected distance refraction, added defocus and 100% contrast ETDRS charts. VA was measured between +1.50 Diopter (D) and -2.50 D in 0.5 D defocus steps, except in the region from +0.50 D through -0.50 D, which was assessed in 0.25 D steps. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified for the first operative eye. No formal statistical hypothesis testing was planned.
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)
Assessment method [4] 0 0
Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed monocularly with the subject's best spectacle correction under mesopic (low, but not quite dark) conditions at a distance of 8 feet (2.45 m) from the eye at a spatial frequency of 12 cpd using the Vector Vision CSV 1000-HGT with and without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. A higher numeric value represented better contrast sensitivity. This analysis was prespecified for the first operative eye.
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?"
Assessment method [5] 0 0
Proportion of subjects was reported as a percentage. No formal statistical hypothesis testing was planned.
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)?"
Assessment method [6] 0 0
No formal statistical hypothesis testing was planned.
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
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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


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