Back to resultsA Clinical Study of the ACRYSOF® IQ EDF Intraocular Lens (IOL)
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ACRYSOF® IQ Extended Depth of Focus IOL
ACRYSOF® IQ Monofocal IOL
Cataract surgery
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
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.
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.
Sites / Locations
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DFT015
SN60WF
Arm Description
ACRYSOF® IQ Extended Depth of Focus Intraocular lens (IOL), bilateral implantation
ACRYSOF® IQ Monofocal IOL, bilateral implantation
Outcomes
Primary Outcome Measures
Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeters (cm)
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.
Percentage of Subjects With Ocular Adverse Events
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.
Secondary Outcome Measures
Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters (m)
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.
Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm
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.
Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve
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.
Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd)
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.
Percentage of Subjects Who Respond "Never" to Question 1 of the Spectacle Use Questionnaire: "How Often Do You Wear Eyeglasses for Any Purpose?"
Proportion of subjects was reported as a percentage. No formal statistical hypothesis testing was planned.
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)?"
No formal statistical hypothesis testing was planned.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03010254
Brief Title
A Clinical Study of the ACRYSOF® IQ EDF Intraocular Lens (IOL)
Official Title
A Prospective, Randomized, Controlled, Multi-Center Clinical Study of the ACRYSOF® IQ Extended Depth of Focus (EDF) IOL
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 21, 2017 (Actual)
Primary Completion Date
August 17, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to demonstrate the safety and performance of the ACRYSOF® IQ EDF IOL.
Detailed Description
Both eyes will be implanted. The second eye implantation will occur a minimum of 7 calendar days and a maximum of 28 calendar days from the first eye implantation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
322 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DFT015
Arm Type
Experimental
Arm Description
ACRYSOF® IQ Extended Depth of Focus Intraocular lens (IOL), bilateral implantation
Arm Title
SN60WF
Arm Type
Active Comparator
Arm Description
ACRYSOF® IQ Monofocal IOL, bilateral implantation
Intervention Type
Device
Intervention Name(s)
ACRYSOF® IQ Extended Depth of Focus IOL
Other Intervention Name(s)
Model DFT015
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
ACRYSOF® IQ Monofocal IOL
Other Intervention Name(s)
Model SN60WF
Intervention Description
Monofocal IOL implanted for long-term use over the lifetime of the pseudophakic subject
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery
Intervention Description
IOL bilateral implantation
Primary Outcome Measure Information:
Title
Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeters (cm)
Description
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.
Time Frame
Month 3 (70-100 days post second eye implantation)
Title
Percentage of Subjects With Ocular Adverse Events
Description
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.
Time Frame
Day 0 (first operative eye visit) up to Month 6 (120-180 days post second eye implantation)
Secondary Outcome Measure Information:
Title
Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters (m)
Description
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.
Time Frame
Month 3 (70-100 days post second eye implantation)
Title
Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm
Description
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.
Time Frame
Month 3 (70-100 days post second eye implantation)
Title
Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve
Description
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.
Time Frame
Month 3 (70-100 days post second eye implantation)
Title
Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd)
Description
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.
Time Frame
Month 6 (120-180 days post second eye implantation)
Title
Percentage of Subjects Who Respond "Never" to Question 1 of the Spectacle Use Questionnaire: "How Often Do You Wear Eyeglasses for Any Purpose?"
Description
Proportion of subjects was reported as a percentage. No formal statistical hypothesis testing was planned.
Time Frame
Month 6 (120-180 days post second eye implantation)
Title
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)?"
Description
No formal statistical hypothesis testing was planned.
Time Frame
Month 6 (120-180 days post second eye implantation)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Senior Clinical Manager, GCRA
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2150
Country
Australia
Facility Name
Alcon Investigative Site
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Alcon Investigative Site
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Alcon Investigative Site
City
Hawthorn East
State/Province
Victoria
ZIP/Postal Code
3123
Country
Australia
Facility Name
Alcon Investigative Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3N9
Country
Canada
Facility Name
Alcon Investigative Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5L1W8
Country
Canada
Facility Name
Alcon Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3N 2V7
Country
Canada
Facility Name
Alcon Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3A9
Country
Canada
Facility Name
Alcon Investigative Site
City
Boisbriand
State/Province
QU
ZIP/Postal Code
J7H 186
Country
Canada
Facility Name
Alcon Investigative Site
City
Québec
State/Province
QU
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Alcon Investigative Site
City
Sant Cugat del Vallès
State/Province
BCN
ZIP/Postal Code
08195
Country
Spain
Facility Name
Alcon Investigative Site
City
Jerez De La Frontera
State/Province
Cadiz
ZIP/Postal Code
11408
Country
Spain
Facility Name
Alcon Investigative Site
City
Barcelona
ZIP/Postal Code
08008
Country
Spain
Facility Name
Alcon Investigative Site
City
Barcelona
ZIP/Postal Code
08021
Country
Spain
Facility Name
Alcon Investigative Site
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Alcon Investigative Site
City
Madrid
ZIP/Postal Code
28003
Country
Spain
Facility Name
Alcon Investigative Site
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Alcon Investigative Site
City
Dartford
State/Province
Kent
ZIP/Postal Code
DA2 8DA
Country
United Kingdom
Facility Name
Alcon Investigative Site
City
Essex
ZIP/Postal Code
SS0 9AG
Country
United Kingdom
Facility Name
Alcon Investigative Site
City
London
ZIP/Postal Code
NW1 5QH
Country
United Kingdom
Facility Name
Alcon Investigative Site
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34288635
Citation
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.
Results Reference
derived
Learn more about this trial
A Clinical Study of the ACRYSOF® IQ EDF Intraocular Lens (IOL)
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