A Clinical Study of the ACRYSOF® IQ Extended Depth of Focus Intraocular Lens (IOL)
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: DFT015 ACRYSOF® IQ Extended Depth of Focus Intraocular lens (IOL), bilateral implantation |
Device: 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.
Other Names:
Procedure: Cataract surgery
IOL bilateral implantation
|
Active Comparator: SN60WF ACRYSOF® IQ Monofocal IOL, bilateral implantation |
Device: ACRYSOF® IQ Monofocal IOL
Monofocal IOL implanted for long-term use over the lifetime of the pseudophakic subject
Other Names:
Procedure: Cataract surgery
IOL bilateral implantation
|
Outcome Measures
Primary Outcome Measures
- Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) [(Logarithm of the Minimum Angle of Resolution (logMAR)] 66 Centimeters (cm) From Spectacle Plane [Month 6 (120-180 days post second eye implantation)]
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.
- Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) logMAR [(4 Meters (m)] From Spectacle Plane [Month 6 (120-180 days post second eye implantation)]
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.
- Monocular Depth of Focus (Measured in the Negative Direction From 0) at 0.20 logMAR From the Mean Defocus Curve [Month 6 (120-180 days post second eye implantation)]
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.
- Percentage of Eyes Achieving Monocular Photopic DCIVA 0.20 logMAR or Better [Month 6 (120-180 days post second eye implantation)]
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.
- Percentage of Subjects With Ocular Adverse Events [Day 0 (first operative eye visit), up to Month 6 (120-180 days post second eye implantation)]
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.
- Mesopic Contrast Sensitivity [Month 6 (120-180 days post second eye implantation)]
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.
Secondary Outcome Measures
- Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) (logMAR) 40 cm From Spectacle Plane [Month 6 (120-180 days post second eye implantation)]
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.
- 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?" [Month 6 (120-180 days post second eye implantation)]
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.
- Monocular Photopic Uncorrected Intermediate Visual Acuity (UCIVA) (logMAR) 66 cm From Spectacle Plane [Month 6 (120-180 days post second eye implantation)]
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.
- Monocular Photopic Uncorrected Distance Visual Acuity (UCDVA) (logMAR) [Month 6 (120-180 days post second eye implantation)]
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.
- Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) [Month 6 (120-180 days post second eye implantation)]
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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Alcon Investigative Site | Birmingham | Alabama | United States | 35213 |
2 | Alcon Investigative Site | Fort Collins | Colorado | United States | 80528 |
3 | Alcon Investigative Site | Bradenton | Florida | United States | 34209 |
4 | Alcon Investigative Site | Sebring | Florida | United States | 33870 |
5 | Alcon Investigative Site | Gainesville | Georgia | United States | 30501 |
6 | Alcon Investigative Site | Rock Island | Illinois | United States | 61201 |
7 | Alcon Investigative Site | Cincinnati | Ohio | United States | 45242 |
8 | Alcon Investigative Site | Allenwood | Pennsylvania | United States | 17810 |
9 | Alcon Investigative Site | Kingston | Pennsylvania | United States | 18704 |
10 | Alcon Investigative Site | West Mifflin | Pennsylvania | United States | 15122 |
11 | Alcon Investigative Site | Sioux Falls | South Dakota | United States | 57108 |
Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Alcon Research, Alcon Research
Study Documents (Full-Text)
More Information
Publications
None provided.- ILI875-C002
Study Results
Participant Flow
Recruitment Details | Subjects were recruited from 11 investigative sites located in the United States. |
---|---|
Pre-assignment Detail | 21 subjects discontinued prior to randomization, and 1 subject discontinued after randomization but prior to attempted implantation. This reporting group includes all subjects with attempted implantation, as treated. Note: 1 subject randomized to DFT015 was implanted with SN60WF. Subject withdrew at the 1 month visit. |
Arm/Group Title | DFT015 | SN60WF |
---|---|---|
Arm/Group Description | ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation | ACRYSOF® IQ Monofocal IOL, bilateral implantation |
Period Title: Overall Study | ||
STARTED | 107 | 113 |
Successful Implantation, as Treated | 107 | 113 |
COMPLETED | 107 | 111 |
NOT COMPLETED | 0 | 2 |
Baseline Characteristics
Arm/Group Title | DFT015 | SN60WF | Total |
---|---|---|---|
Arm/Group Description | ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation | ACRYSOF® IQ Monofocal IOL, bilateral implantation | Total of all reporting groups |
Overall Participants | 107 | 113 | 220 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
68.8
(7.82)
|
68.8
(6.63)
|
68.8
(7.22)
|
Sex: Female, Male (Count of Participants) | |||
Female |
59
55.1%
|
64
56.6%
|
123
55.9%
|
Male |
48
44.9%
|
49
43.4%
|
97
44.1%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
2
1.9%
|
2
1.8%
|
4
1.8%
|
Not Hispanic or Latino |
104
97.2%
|
111
98.2%
|
215
97.7%
|
Unknown or Not Reported |
1
0.9%
|
0
0%
|
1
0.5%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
1
0.9%
|
1
0.5%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
1
0.9%
|
1
0.9%
|
2
0.9%
|
White |
105
98.1%
|
110
97.3%
|
215
97.7%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
1
0.9%
|
1
0.9%
|
2
0.9%
|
Outcome Measures
Title | Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) [(Logarithm of the Minimum Angle of Resolution (logMAR)] 66 Centimeters (cm) From Spectacle Plane |
---|---|
Description | 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. |
Time Frame | Month 6 (120-180 days post second eye implantation) |
Outcome Measure Data
Analysis Population Description |
---|
All-Implanted Analysis Set, as treated |
Arm/Group Title | DFT015 | SN60WF |
---|---|---|
Arm/Group Description | ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation | ACRYSOF® IQ Monofocal IOL, bilateral implantation |
Measure Participants | 107 | 111 |
Measure Eyes | 107 | 111 |
Least Squares Mean (Standard Error) [logMAR] |
0.148
(0.0120)
|
0.312
(0.0118)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | DFT015, SN60WF |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | 2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided. | |
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.164 | |
Confidence Interval |
(2-Sided) 95% -0.197 to -0.131 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.0168 |
|
Estimation Comments | Least squares mean difference (DFT015 - SN60WF) |
Title | Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) logMAR [(4 Meters (m)] From Spectacle Plane |
---|---|
Description | 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. |
Time Frame | Month 6 (120-180 days post second eye implantation) |
Outcome Measure Data
Analysis Population Description |
---|
All-Implanted Analysis Set, as treated |
Arm/Group Title | DFT015 | SN60WF |
---|---|---|
Arm/Group Description | ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation | ACRYSOF® IQ Monofocal IOL, bilateral implantation |
Measure Participants | 107 | 111 |
Measure Eyes | 107 | 111 |
Least Squares Mean (Standard Error) [logMAR] |
0.016
(0.0091)
|
-0.036
(0.0089)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | DFT015, SN60WF |
---|---|---|
Comments | ||
Type of Statistical Test | Non-Inferiority | |
Comments | Non-Inferiority margin was 0.1 logMAR. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.052 | |
Confidence Interval |
(1-Sided) 95% to 0.073 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.0127 |
|
Estimation Comments | Least squares mean difference (DFT015 - SN60WF). The 1-sided 95% Upper Confidence Limit is presented. |
Title | Monocular Depth of Focus (Measured in the Negative Direction From 0) at 0.20 logMAR From the Mean Defocus Curve |
---|---|
Description | 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. |
Time Frame | Month 6 (120-180 days post second eye implantation) |
Outcome Measure Data
Analysis Population Description |
---|
All-Implanted Analysis Set, as treated. Number analyzed is the number of subjects/eyes with data available for analysis at specified defocus. |
Arm/Group Title | DFT015 | SN60WF |
---|---|---|
Arm/Group Description | ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation | ACRYSOF® IQ Monofocal IOL, bilateral implantation |
Measure Participants | 107 | 111 |
Measure Eyes | 107 | 111 |
Number [diopter] |
1.53
|
0.99
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | DFT015, SN60WF |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in depth of focus |
Estimated Value | 0.54 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Difference in depth of focus (DFT015 - SN60WF) |
Title | Percentage of Eyes Achieving Monocular Photopic DCIVA 0.20 logMAR or Better |
---|---|
Description | 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. |
Time Frame | Month 6 (120-180 days post second eye implantation) |
Outcome Measure Data
Analysis Population Description |
---|
All-Implanted Analysis Set, as treated. |
Arm/Group Title | DFT015 | SN60WF |
---|---|---|
Arm/Group Description | ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation | ACRYSOF® IQ Monofocal IOL, bilateral implantation |
Measure Participants | 107 | 111 |
Measure Eyes | 107 | 111 |
Number [percentage of eyes] |
72.9
|
25.2
|
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 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. |
Time Frame | Day 0 (first operative eye visit), up to Month 6 (120-180 days post second eye implantation) |
Outcome Measure Data
Analysis Population Description |
---|
This analysis population included all eyes with attempted IOL implantation (successful or aborted after contact with the eye) (Safety Analysis Set). |
Arm/Group Title | DFT015 First Eye | DFT015 Second Eye |
---|---|---|
Arm/Group Description | All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the first implanted eye | All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the second implanted eye |
Measure Participants | 107 | 106 |
Measure Eyes | 107 | 106 |
Cumulative: Cystoid macular oedema |
0.9
|
0.0
|
Cumulative: Hypopyon |
0.0
|
0.0
|
Cumulative: Endophthalmitis |
0.0
|
0.0
|
Cumulative: Lens dislocated from posterior chamber |
0.0
|
0.0
|
Cumulative: Pupillary block |
0.0
|
0.0
|
Cumulative: Retinal detachment |
0.0
|
0.0
|
Cumulative: Secondary surgical intervention |
0.0
|
1.9
|
Cumulative: Cataract operation complication |
0.0
|
1.9
|
Cumulative: Hyphaema |
0.9
|
0.0
|
Cumulative: Transient ischaemic attack |
0.9
|
0.0
|
Persistent: Corneal stroma oedema |
0.0
|
0.0
|
Persistent: Cystoid macular oedema |
0.0
|
0.0
|
Persistent: Iritis |
0.0
|
0.0
|
Persistent: Raised IOP requiring treatment |
0.0
|
0.0
|
Title | Mesopic Contrast Sensitivity |
---|---|
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 (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. |
Time Frame | Month 6 (120-180 days post second eye implantation) |
Outcome Measure Data
Analysis Population Description |
---|
Safety Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at without glare and with glare assessments. |
Arm/Group Title | DFT015 | SN60WF |
---|---|---|
Arm/Group Description | ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation | ACRYSOF® IQ Monofocal IOL, bilateral implantation |
Measure Participants | 107 | 113 |
Measure Eyes | 107 | 113 |
1.5 cpd Without Glare |
1.506
(0.2560)
|
1.498
(0.2434)
|
3 cpd Without Glare |
1.447
(0.3381)
|
1.482
(0.2829)
|
6 cpd Without Glare |
1.340
(0.3850)
|
1.548
(0.3177)
|
12 cpd Without Glare |
0.840
(0.3681)
|
1.003
(0.3769)
|
1.5 cpd With Glare |
1.504
(0.2555)
|
1.475
(0.2569)
|
3 cpd With Glare |
1.458
(0.3304)
|
1.499
(0.2838)
|
6 cpd With Glare |
1.364
(0.3856)
|
1.529
(0.3256)
|
12 cpd With Glare |
0.817
(0.3494)
|
0.999
(0.4020)
|
Title | Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) (logMAR) 40 cm From Spectacle Plane |
---|---|
Description | 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. |
Time Frame | Month 6 (120-180 days post second eye implantation) |
Outcome Measure Data
Analysis Population Description |
---|
All-Implanted Analysis Set, as treated. |
Arm/Group Title | DFT015 | SN60WF |
---|---|---|
Arm/Group Description | ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation | ACRYSOF® IQ Monofocal IOL, bilateral implantation |
Measure Participants | 107 | 111 |
Measure Eyes | 107 | 111 |
Least Squares Mean (Standard Error) [logMAR] |
0.359
(0.0147)
|
0.515
(0.0144)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | DFT015, SN60WF |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | 2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided. | |
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.156 | |
Confidence Interval |
(2-Sided) 95% -0.197 to -0.115 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.0206 |
|
Estimation Comments | Least squares mean difference (DFT015 - SN60WF) |
Title | 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?" |
---|---|
Description | 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. |
Time Frame | Month 6 (120-180 days post second eye implantation) |
Outcome Measure Data
Analysis Population Description |
---|
All-Implanted Analysis Set, as treated. |
Arm/Group Title | DFT015 | SN60WF |
---|---|---|
Arm/Group Description | ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation | ACRYSOF® IQ Monofocal IOL, bilateral implantation |
Measure Participants | 102 | 111 |
Number [percentage of subjects] |
21.6
|
3.6
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | DFT015, SN60WF |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in percentage |
Estimated Value | 18 | |
Confidence Interval |
(2-Sided) 95% 9.65 to 27.37 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | 95% CI for the difference (DFT015 - SN60WF) is estimated using Miettinen-Nurminen method (1985). |
Title | Monocular Photopic Uncorrected Intermediate Visual Acuity (UCIVA) (logMAR) 66 cm From Spectacle Plane |
---|---|
Description | 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. |
Time Frame | Month 6 (120-180 days post second eye implantation) |
Outcome Measure Data
Analysis Population Description |
---|
All-Implanted Analysis Set, as treated. |
Arm/Group Title | DFT015 | SN60WF |
---|---|---|
Arm/Group Description | ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation | ACRYSOF® IQ Monofocal IOL, bilateral implantation |
Measure Participants | 107 | 111 |
Measure Eyes | 107 | 111 |
Mean (Standard Deviation) [logMAR] |
0.136
(0.110)
|
0.261
(0.147)
|
Title | Monocular Photopic Uncorrected Distance Visual Acuity (UCDVA) (logMAR) |
---|---|
Description | 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. |
Time Frame | Month 6 (120-180 days post second eye implantation) |
Outcome Measure Data
Analysis Population Description |
---|
All-Implanted Analysis Set, as treated. |
Arm/Group Title | DFT015 | SN60WF |
---|---|---|
Arm/Group Description | ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation | ACRYSOF® IQ Monofocal IOL, bilateral implantation |
Measure Participants | 107 | 111 |
Measure Eyes | 107 | 111 |
Mean (Standard Deviation) [logMAR] |
0.117
(0.122)
|
0.056
(0.148)
|
Title | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) |
---|---|
Description | 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. |
Time Frame | Month 6 (120-180 days post second eye implantation) |
Outcome Measure Data
Analysis Population Description |
---|
Safety Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at specified visual disturbances. |
Arm/Group Title | DFT015 | SN60WF |
---|---|---|
Arm/Group Description | ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation | ACRYSOF® IQ Monofocal IOL, bilateral implantation |
Measure Participants | 106 | 113 |
Severe: Starbursts |
3.8
|
2.7
|
Severe: Halos |
0.9
|
0.9
|
Severe: Glare |
0.0
|
0.0
|
Severe: Hazy vision |
0.0
|
0.0
|
Severe: Blurred vision |
0.0
|
0.0
|
Severe: Double vision |
0.0
|
0.0
|
Severe: Dark area |
0.9
|
0.9
|
Most Bothersome: Starbursts |
1.9
|
0.9
|
Most Bothersome: Halos |
0.9
|
0.0
|
Most Bothersome: Glare |
0.0
|
0.0
|
Most Bothersome: Hazy vision |
0.0
|
0.0
|
Most Bothersome: Blurred vision |
0.9
|
1.8
|
Most Bothersome: Double vision |
0.0
|
0.0
|
Most Bothersome: Dark area |
0.9
|
0.9
|
Adverse Events
Time Frame | Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes. | |||||||||||||
Arm/Group Title | Preoperative | DFT015 First Eye | DFT015 Second Eye | DFT015 Systemic | SN60WF First Eye | SN60WF Second Eye | SN60WF Systemic | |||||||
Arm/Group Description | All subjects in the safety analysis set prior to initiation of treatment | All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the first implanted eye | All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the second implanted eye | All subjects with attempted test article implantation (successful or aborted after contact with the eye) | All eyes with attempted control article implantation (successful or aborted after contact with the eye) in the first implanted eye | All eyes with attempted control article implantation (successful or aborted after contact with the eye) in the second implanted eye | All subjects with attempted control article implantation (successful or aborted after contact with the eye) | |||||||
All Cause Mortality |
||||||||||||||
Preoperative | DFT015 First Eye | DFT015 Second Eye | DFT015 Systemic | SN60WF First Eye | SN60WF Second Eye | SN60WF Systemic | ||||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/220 (0%) | 0/107 (0%) | 0/106 (0%) | 0/107 (0%) | 0/113 (0%) | 0/113 (0%) | 0/113 (0%) | |||||||
Serious Adverse Events |
||||||||||||||
Preoperative | DFT015 First Eye | DFT015 Second Eye | DFT015 Systemic | SN60WF First Eye | SN60WF Second Eye | SN60WF Systemic | ||||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/220 (0%) | 3/107 (2.8%) | 2/106 (1.9%) | 7/107 (6.5%) | 3/113 (2.7%) | 1/113 (0.9%) | 4/113 (3.5%) | |||||||
Cardiac disorders | ||||||||||||||
Coronary artery disease | 0/220 (0%) | 0/107 (0%) | 0/106 (0%) | 0/107 (0%) | 0/113 (0%) | 0/113 (0%) | 1/113 (0.9%) | |||||||
Heart valve incompetence | 0/220 (0%) | 0/107 (0%) | 0/106 (0%) | 0/107 (0%) | 0/113 (0%) | 0/113 (0%) | 1/113 (0.9%) | |||||||
Eye disorders | ||||||||||||||
Cystoid macular oedema | 0/220 (0%) | 1/107 (0.9%) | 0/106 (0%) | 0/107 (0%) | 1/113 (0.9%) | 1/113 (0.9%) | 0/113 (0%) | |||||||
Photopsia | 0/220 (0%) | 0/107 (0%) | 0/106 (0%) | 0/107 (0%) | 1/113 (0.9%) | 0/113 (0%) | 0/113 (0%) | |||||||
Retinal detachment | 0/220 (0%) | 0/107 (0%) | 0/106 (0%) | 0/107 (0%) | 1/113 (0.9%) | 0/113 (0%) | 0/113 (0%) | |||||||
Hyphaema | 0/220 (0%) | 1/107 (0.9%) | 0/106 (0%) | 0/107 (0%) | 0/113 (0%) | 0/113 (0%) | 0/113 (0%) | |||||||
Gastrointestinal disorders | ||||||||||||||
Peptic ulcer | 0/220 (0%) | 0/107 (0%) | 0/106 (0%) | 1/107 (0.9%) | 0/113 (0%) | 0/113 (0%) | 0/113 (0%) | |||||||
General disorders | ||||||||||||||
Ulcer haemorrhage | 0/220 (0%) | 0/107 (0%) | 0/106 (0%) | 0/107 (0%) | 0/113 (0%) | 0/113 (0%) | 1/113 (0.9%) | |||||||
Hepatobiliary disorders | ||||||||||||||
Cholelithiasis | 0/220 (0%) | 0/107 (0%) | 0/106 (0%) | 1/107 (0.9%) | 0/113 (0%) | 0/113 (0%) | 0/113 (0%) | |||||||
Infections and infestations | ||||||||||||||
Abdominal abscess | 0/220 (0%) | 0/107 (0%) | 0/106 (0%) | 1/107 (0.9%) | 0/113 (0%) | 0/113 (0%) | 0/113 (0%) | |||||||
Pneumonia | 0/220 (0%) | 0/107 (0%) | 0/106 (0%) | 2/107 (1.9%) | 0/113 (0%) | 0/113 (0%) | 0/113 (0%) | |||||||
Injury, poisoning and procedural complications | ||||||||||||||
Bladder injury | 0/220 (0%) | 0/107 (0%) | 0/106 (0%) | 1/107 (0.9%) | 0/113 (0%) | 0/113 (0%) | 0/113 (0%) | |||||||
Cataract operation complication | 0/220 (0%) | 0/107 (0%) | 2/106 (1.9%) | 0/107 (0%) | 0/113 (0%) | 0/113 (0%) | 0/113 (0%) | |||||||
Femoral neck fracture | 0/220 (0%) | 0/107 (0%) | 0/106 (0%) | 0/107 (0%) | 0/113 (0%) | 0/113 (0%) | 1/113 (0.9%) | |||||||
Post procedural bile leak | 0/220 (0%) | 0/107 (0%) | 0/106 (0%) | 1/107 (0.9%) | 0/113 (0%) | 0/113 (0%) | 0/113 (0%) | |||||||
Spinal fracture | 0/220 (0%) | 0/107 (0%) | 0/106 (0%) | 1/107 (0.9%) | 0/113 (0%) | 0/113 (0%) | 0/113 (0%) | |||||||
Surgical procedure repeated | 0/220 (0%) | 0/107 (0%) | 2/106 (1.9%) | 0/107 (0%) | 0/113 (0%) | 0/113 (0%) | 0/113 (0%) | |||||||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||
Breast cancer | 0/220 (0%) | 0/107 (0%) | 0/106 (0%) | 1/107 (0.9%) | 0/113 (0%) | 0/113 (0%) | 0/113 (0%) | |||||||
Nervous system disorders | ||||||||||||||
Transient ischaemic attack | 0/220 (0%) | 1/107 (0.9%) | 0/106 (0%) | 0/107 (0%) | 0/113 (0%) | 0/113 (0%) | 0/113 (0%) | |||||||
Psychiatric disorders | ||||||||||||||
Panic attack | 0/220 (0%) | 0/107 (0%) | 0/106 (0%) | 1/107 (0.9%) | 0/113 (0%) | 0/113 (0%) | 0/113 (0%) | |||||||
Respiratory, thoracic and mediastinal disorders | ||||||||||||||
Chronic obstructive pulmonary disease | 0/220 (0%) | 0/107 (0%) | 0/106 (0%) | 1/107 (0.9%) | 0/113 (0%) | 0/113 (0%) | 0/113 (0%) | |||||||
Surgical and medical procedures | ||||||||||||||
Aneurysm repair | 0/220 (0%) | 0/107 (0%) | 0/106 (0%) | 0/107 (0%) | 0/113 (0%) | 0/113 (0%) | 1/113 (0.9%) | |||||||
Lens extraction | 0/220 (0%) | 0/107 (0%) | 0/106 (0%) | 0/107 (0%) | 1/113 (0.9%) | 0/113 (0%) | 0/113 (0%) | |||||||
Vitrectomy | 0/220 (0%) | 0/107 (0%) | 0/106 (0%) | 0/107 (0%) | 1/113 (0.9%) | 0/113 (0%) | 0/113 (0%) | |||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||
Preoperative | DFT015 First Eye | DFT015 Second Eye | DFT015 Systemic | SN60WF First Eye | SN60WF Second Eye | SN60WF Systemic | ||||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/220 (0%) | 5/107 (4.7%) | 6/106 (5.7%) | 0/107 (0%) | 9/113 (8%) | 8/113 (7.1%) | 0/113 (0%) | |||||||
Eye disorders | ||||||||||||||
Posterior capsule opacification | 0/220 (0%) | 5/107 (4.7%) | 6/106 (5.7%) | 0/107 (0%) | 9/113 (8%) | 8/113 (7.1%) | 0/113 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Name/Title | CDMA Project Lead |
---|---|
Organization | Alcon Research |
Phone | 1-888-451-3937 |
alcon.medinfo@alcon.com |
- ILI875-C002