- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03274986
A Clinical Study of the ACRYSOF® IQ Extended Depth of Focus Intraocular Lens (IOL)
March 25, 2020 updated by: Alcon Research
A Prospective, Randomized, Controlled, Multi-Center Clinical Study of the ACRYSOF® IQ Extended Depth of Focus IOL
The purpose of the study is to demonstrate the safety and performance of ACRYSOF IQ extended depth of focus (EDF) intraocular lens (IOL) at Month 6. Depth of focus (DOF) is the amount of focal plane displacement behind a lens that does not degrade the image quality of a distant object.
A larger DOF allows sharp images of closer objects and may provide improved vision at intermediate and near distances.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Both eyes of a subject must require cataract surgery to qualify for enrollment into this study.
Subjects participating in the trial will attend a total of 9 scheduled study visits over a 7-8 month period.
Of the 9 visits, 1 is preoperative, 2 are operative, and the remaining 6 are postoperative visits.
Primary endpoint data will be collected at the Month 6 (Day 120-180) post second eye implantation visit.
Study Type
Interventional
Enrollment (Actual)
242
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35213
- Alcon Investigative Site
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Colorado
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Fort Collins, Colorado, United States, 80528
- Alcon Investigative Site
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Florida
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Bradenton, Florida, United States, 34209
- Alcon Investigative Site
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Sebring, Florida, United States, 33870
- Alcon Investigative Site
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Georgia
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Gainesville, Georgia, United States, 30501
- Alcon Investigative Site
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Illinois
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Rock Island, Illinois, United States, 61201
- Alcon Investigative Site
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Ohio
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Cincinnati, Ohio, United States, 45242
- Alcon Investigative Site
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Pennsylvania
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Allenwood, Pennsylvania, United States, 17810
- Alcon Investigative Site
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Kingston, Pennsylvania, United States, 18704
- Alcon Investigative Site
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West Mifflin, Pennsylvania, United States, 15122
- Alcon Investigative Site
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South Dakota
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Sioux Falls, South Dakota, United States, 57108
- Alcon Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logarithm of the minimum angle of resolution (logMAR) (20/40 Snellen) or worse either with or without a glare source present (e.g., Brightness Acuity Tester)
- Preoperative regular astigmatism of < 1.0 D in both eyes
- Clear intraocular media other than cataract
- Diagnosed with cataract in both eyes
- Planned cataract removal by routine small incision surgery
- Calculated lens power between 18.0 and 25.0 diopter (D) [when targeted for emmetropia (0.0 D)]
- Willing and able to complete all required postoperative visits
- Able to comprehend and sign an ethics committee-approved statement of informed consent
- Potential postoperative BCDVA of 0.2 logMAR (20/32 Snellen) or better in each eye based on Investigator's medical opinion.
Exclusion Criteria:
- History of eye pathology and/or inflammation, as specified in the protocol
- Clinically significant/severe ocular surface disease that would affect study measurements based on Investigator expert medical opinion
- History of previous intraocular or corneal surgery
- Pregnant/lactating or has another condition with associated fluctuation of hormones that could lead to refractive changes
- Taking systemic medications that in the Investigator's best medical judgment may confound the outcome or increase the risk to the subject.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: DFT015
ACRYSOF® IQ Extended Depth of Focus Intraocular lens (IOL), bilateral implantation
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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.
Other Names:
IOL bilateral implantation
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Active Comparator: SN60WF
ACRYSOF® IQ Monofocal IOL, bilateral implantation
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IOL bilateral implantation
Monofocal IOL implanted for long-term use over the lifetime of the pseudophakic subject
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) [(Logarithm of the Minimum Angle of Resolution (logMAR)] 66 Centimeters (cm) From Spectacle Plane
Time Frame: Month 6 (120-180 days post second eye implantation)
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Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction adjusted for optical infinity, electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 66 cm from the spectacle plane.
DCIVA 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.
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Month 6 (120-180 days post second eye implantation)
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Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) logMAR [(4 Meters (m)] From Spectacle Plane
Time Frame: Month 6 (120-180 days post second eye implantation)
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VA was tested monocularly under photopic conditions using the correction obtained from the best correction and no optical infinity adjustment, electronic 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.
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Month 6 (120-180 days post second eye implantation)
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Monocular Depth of Focus (Measured in the Negative Direction From 0) at 0.20 logMAR From the Mean Defocus Curve
Time Frame: Month 6 (120-180 days post second eye implantation)
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Depth of focus was assessed at 4 meters under photopic (well-lit) conditions using best corrected distance refraction and added defocus.
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.
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Month 6 (120-180 days post second eye implantation)
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Percentage of Eyes Achieving Monocular Photopic DCIVA 0.20 logMAR or Better
Time Frame: Month 6 (120-180 days post second eye implantation)
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VA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS charts at a distance of 66 cm from the eye.
DCIVA 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.
No formal statistical hypothesis testing was planned.
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Month 6 (120-180 days post second eye implantation)
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Percentage of Subjects With Ocular Adverse Events
Time Frame: Day 0 (first operative eye visit), up to Month 6 (120-180 days post second eye implantation)
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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 in ISO 11979-7:2014 were collected.
This outcome measure was prespecified for the Model DFT015 first and second eyes.
No formal statistical hypothesis testing was planned.
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Day 0 (first operative eye visit), up to Month 6 (120-180 days post second eye implantation)
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Mesopic Contrast Sensitivity
Time Frame: Month 6 (120-180 days post second eye implantation)
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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 (2.45 m) feet from the eye at a spatial frequency of 1.5, 3, 6, and 12 cycles per degree (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.
No formal statistical hypothesis testing was planned.
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Month 6 (120-180 days post second eye implantation)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) (logMAR) 40 cm From Spectacle Plane
Time Frame: Month 6 (120-180 days post second eye implantation)
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VA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS chart set at 40 cm 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.
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Month 6 (120-180 days post second eye implantation)
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Percentage of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire: "Overall, in the Past 7 Days, How Often Did You Need to Wear Eyeglasses to See?"
Time Frame: Month 6 (120-180 days post second eye implantation)
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The IOLSAT questionnaire assessed the subjective quality of vision with respect to need for spectacles, as well as the subject's expectation and satisfaction with their quality of vision at 6 months.
Results are reported consistent with multiple testing strategy.
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Month 6 (120-180 days post second eye implantation)
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Monocular Photopic Uncorrected Intermediate Visual Acuity (UCIVA) (logMAR) 66 cm From Spectacle Plane
Time Frame: Month 6 (120-180 days post second eye implantation)
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VA was tested monocularly under photopic conditions with no refractive correction or adjustment for optical infinity, using electronic ETDRS charts at a distance of 66 cm from the spectacle plane.
UCIVA 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.
No formal statistical hypothesis testing was planned.
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Month 6 (120-180 days post second eye implantation)
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Monocular Photopic Uncorrected Distance Visual Acuity (UCDVA) (logMAR)
Time Frame: Month 6 (120-180 days post second eye implantation)
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VA was tested monocularly under photopic conditions without refractive correction but with adjustment for optical infinity, electronic ETDRS charts at a distance of 4 m from the eye.
+0.25 D spherical power was applied to correct for optical infinity.
UCDVA 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.
No formal statistical hypothesis testing was planned.
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Month 6 (120-180 days post second eye implantation)
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Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)
Time Frame: Month 6 (120-180 days post second eye implantation)
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Rates of severe and most bothersome visual disturbances as reported by the subjects on the QUVID questionnaire, a Patient Reported Outcome (PRO) questionnaire.
No formal statistical hypothesis testing was planned.
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Month 6 (120-180 days post second eye implantation)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 11, 2017
Primary Completion (Actual)
October 16, 2018
Study Completion (Actual)
October 16, 2018
Study Registration Dates
First Submitted
September 5, 2017
First Submitted That Met QC Criteria
September 5, 2017
First Posted (Actual)
September 7, 2017
Study Record Updates
Last Update Posted (Actual)
April 7, 2020
Last Update Submitted That Met QC Criteria
March 25, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ILI875-C002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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