Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
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)
Query!
Scientific title
A Prospective, Randomized, Controlled, Multi-Center Clinical Study of the ACRYSOF® IQ Extended Depth of Focus (EDF) IOL
Query!
Secondary ID [1]
0
0
ILI875-C001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Cataract
0
0
Query!
Condition category
Condition code
Eye
0
0
0
0
Query!
Diseases / disorders of the eye
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Intervention code [2]
0
0
Treatment: Surgery
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeters (cm)
Query!
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.
Query!
Timepoint [1]
0
0
Month 3 (70-100 days post second eye implantation)
Query!
Primary outcome [2]
0
0
Percentage of Subjects With Ocular Adverse Events
Query!
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.
Query!
Timepoint [2]
0
0
Day 0 (first operative eye visit) up to Month 6 (120-180 days post second eye implantation)
Query!
Secondary outcome [1]
0
0
Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters (m)
Query!
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.
Query!
Timepoint [1]
0
0
Month 3 (70-100 days post second eye implantation)
Query!
Secondary outcome [2]
0
0
Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm
Query!
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.
Query!
Timepoint [2]
0
0
Month 3 (70-100 days post second eye implantation)
Query!
Secondary outcome [3]
0
0
Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve
Query!
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.
Query!
Timepoint [3]
0
0
Month 3 (70-100 days post second eye implantation)
Query!
Secondary outcome [4]
0
0
Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd)
Query!
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.
Query!
Timepoint [4]
0
0
Month 6 (120-180 days post second eye implantation)
Query!
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?"
Query!
Assessment method [5]
0
0
Proportion of subjects was reported as a percentage. No formal statistical hypothesis testing was planned.
Query!
Timepoint [5]
0
0
Month 6 (120-180 days post second eye implantation)
Query!
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)?"
Query!
Assessment method [6]
0
0
No formal statistical hypothesis testing was planned.
Query!
Timepoint [6]
0
0
Month 6 (120-180 days post second eye implantation)
Query!
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.
Query!
Minimum age
22
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
NA
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
21/03/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
31/10/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
322
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
Alcon Investigative Site - Sydney
Query!
Recruitment hospital [2]
0
0
Alcon Investigative Site - Southport
Query!
Recruitment hospital [3]
0
0
Alcon Investigative Site - Footscray
Query!
Recruitment hospital [4]
0
0
Alcon Investigative Site - Hawthorn East
Query!
Recruitment postcode(s) [1]
0
0
2150 - Sydney
Query!
Recruitment postcode(s) [2]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [3]
0
0
3011 - Footscray
Query!
Recruitment postcode(s) [4]
0
0
3123 - Hawthorn East
Query!
Recruitment outside Australia
Country [1]
0
0
Canada
Query!
State/province [1]
0
0
British Columbia
Query!
Country [2]
0
0
Canada
Query!
State/province [2]
0
0
Ontario
Query!
Country [3]
0
0
Canada
Query!
State/province [3]
0
0
QU
Query!
Country [4]
0
0
Spain
Query!
State/province [4]
0
0
BCN
Query!
Country [5]
0
0
Spain
Query!
State/province [5]
0
0
Cadiz
Query!
Country [6]
0
0
Spain
Query!
State/province [6]
0
0
Barcelona
Query!
Country [7]
0
0
Spain
Query!
State/province [7]
0
0
Madrid
Query!
Country [8]
0
0
Spain
Query!
State/province [8]
0
0
Valencia
Query!
Country [9]
0
0
United Kingdom
Query!
State/province [9]
0
0
Kent
Query!
Country [10]
0
0
United Kingdom
Query!
State/province [10]
0
0
Essex
Query!
Country [11]
0
0
United Kingdom
Query!
State/province [11]
0
0
London
Query!
Country [12]
0
0
United Kingdom
Query!
State/province [12]
0
0
Manchester
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Alcon Research
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of the study is to demonstrate the safety and performance of the ACRYSOF® IQ EDF IOL.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03010254
Query!
Trial related presentations / publications
Bala C, Poyales F, Guarro M, Mesa RR, Mearza A, Varma DK, Jasti S, Lemp-Hull J. Multicountry clinical outcomes of a new nondiffractive presbyopia-correcting IOL. J Cataract Refract Surg. 2022 Feb 1;48(2):136-143. doi: 10.1097/j.jcrs.0000000000000712.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Senior Clinical Manager, GCRA
Query!
Address
0
0
Alcon Research
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/54/NCT03010254/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/54/NCT03010254/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03010254