A Clinical Study of the ACRYSOF® IQ EDF Intraocular Lens (IOL)
Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT03010254
Collaborator
(none)
322
21
2
19.4
15.3
0.8
Study Details
Study Description
Brief Summary
The purpose of the study is to demonstrate the safety and performance of the ACRYSOF® IQ EDF IOL.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
322 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Prospective, Randomized, Controlled, Multi-Center Clinical Study of the ACRYSOF® IQ Extended Depth of Focus (EDF) IOL
Actual Study Start Date
:
Mar 21, 2017
Actual Primary Completion Date
:
Aug 17, 2018
Actual Study Completion Date
:
Oct 31, 2018
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; intended for long-term use over the lifetime of the pseudophakic subject
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) at 66 Centimeters (cm) [Month 3 (70-100 days post second eye implantation)]
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 [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 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) [Month 3 (70-100 days post second eye implantation)]
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 [Month 3 (70-100 days post second eye implantation)]
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 [Month 3 (70-100 days post second eye implantation)]
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) [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 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?" [Month 6 (120-180 days post second eye implantation)]
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)?" [Month 6 (120-180 days post second eye implantation)]
No formal statistical hypothesis testing was planned.
Eligibility Criteria
Criteria
Ages Eligible for Study:
22 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alcon Investigative Site | Sydney | New South Wales | Australia | 2150 |
| 2 | Alcon Investigative Site | Southport | Queensland | Australia | 4215 |
| 3 | Alcon Investigative Site | Footscray | Victoria | Australia | 3011 |
| 4 | Alcon Investigative Site | Hawthorn East | Victoria | Australia | 3123 |
| 5 | Alcon Investigative Site | Vancouver | British Columbia | Canada | V5Z 3N9 |
| 6 | Alcon Investigative Site | Mississauga | Ontario | Canada | L5L1W8 |
| 7 | Alcon Investigative Site | Toronto | Ontario | Canada | M3N 2V7 |
| 8 | Alcon Investigative Site | Toronto | Ontario | Canada | M5T 3A9 |
| 9 | Alcon Investigative Site | Boisbriand | QU | Canada | J7H 186 |
| 10 | Alcon Investigative Site | Québec | QU | Canada | G1S 4L8 |
| 11 | Alcon Investigative Site | Sant Cugat del Vallès | BCN | Spain | 08195 |
| 12 | Alcon Investigative Site | Jerez De La Frontera | Cadiz | Spain | 11408 |
| 13 | Alcon Investigative Site | Barcelona | Spain | 08008 | |
| 14 | Alcon Investigative Site | Barcelona | Spain | 08021 | |
| 15 | Alcon Investigative Site | Barcelona | Spain | 08022 | |
| 16 | Alcon Investigative Site | Madrid | Spain | 28003 | |
| 17 | Alcon Investigative Site | Valencia | Spain | 46015 | |
| 18 | Alcon Investigative Site | Dartford | Kent | United Kingdom | DA2 8DA |
| 19 | Alcon Investigative Site | Essex | United Kingdom | SS0 9AG | |
| 20 | Alcon Investigative Site | London | United Kingdom | NW1 5QH | |
| 21 | Alcon Investigative Site | Manchester | United Kingdom | M13 9WL |
Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Senior Clinical Manager, GCRA, Alcon Research
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT03010254
Other Study ID Numbers:
- ILI875-C001
First Posted:
Jan 5, 2017
Last Update Posted:
Apr 7, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Subjects were recruited from 21 investigative sites located in Australia, Canada, Spain and the United Kingdom. |
|---|---|
| Pre-assignment Detail | A total of 322 subjects were enrolled in the study, out of which 39 subjects exited due to screen failure and 1 subject discontinued due to site being closed before actual screening visit and randomization. This reporting group includes all randomized subjects. |
| Arm/Group Title | DFT015 | SN60WF |
|---|---|---|
| Arm/Group Description | ACRYSOF® IQ Extended Depth of Focus Intraocular lens (IOL), bilateral implantation | ACRYSOF® IQ Monofocal IOL, bilateral implantation |
| Period Title: Overall Study | ||
| STARTED | 159 | 123 |
| Attempted Implantation | 156 | 120 |
| Successful Implantation | 156 | 120 |
| COMPLETED | 152 | 118 |
| NOT COMPLETED | 7 | 5 |
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 | 156 | 120 | 276 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
69.7
(7.37)
|
69.7
(7.54)
|
69.7
(7.43)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
94
60.3%
|
65
54.2%
|
159
57.6%
|
| Male |
62
39.7%
|
55
45.8%
|
117
42.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
31
19.9%
|
25
20.8%
|
56
20.3%
|
| Not Hispanic or Latino |
107
68.6%
|
79
65.8%
|
186
67.4%
|
| Unknown or Not Reported |
18
11.5%
|
16
13.3%
|
34
12.3%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
12
7.7%
|
8
6.7%
|
20
7.2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
4
2.6%
|
1
0.8%
|
5
1.8%
|
| White |
129
82.7%
|
101
84.2%
|
230
83.3%
|
| More than one race |
1
0.6%
|
0
0%
|
1
0.4%
|
| Unknown or Not Reported |
10
6.4%
|
10
8.3%
|
20
7.2%
|
Outcome Measures
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All-Implanted Analysis Set |
| 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 | 153 | 115 |
| Measure Eyes | 153 | 115 |
| Least Squares Mean (Standard Error) [logMAR] |
0.175
(0.0137)
|
0.313
(0.0158)
|
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 | -0.138 | |
| Confidence Interval |
(2-Sided) 95% -0.180 to -0.097 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.0210 |
|
| Estimation Comments | Least squares mean difference (DFT015 - SN60WF) | |
| 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) |
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). This outcome measure was pre-specified for the ACRYSOF® IQ Extended Depth of Focus IOL DTF015 only. |
| 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 | 156 | 154 |
| Measure Eyes | 156 | 154 |
| Cumulative: Cystoid macular oedema |
0.6
|
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 |
0.6
|
0.6
|
| 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 | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All-Implanted Analysis Set |
| 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 | 153 | 115 |
| Measure Eyes | 153 | 115 |
| Least Squares Mean (Standard Error) [logMAR] |
-0.007
(0.0076)
|
-0.044
(0.0087)
|
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 | 0.037 | |
| Confidence Interval |
(1-Sided) 97.5% to 0.059 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.0115 |
|
| Estimation Comments | Least squares mean difference (DFT015 - SN60WF).The 1-sided 97.5% Upper Confidence Limit is presented. | |
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All-Implanted Analysis Set |
| 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 | 153 | 115 |
| Measure Eyes | 153 | 115 |
| Least Squares Mean (Standard Error) [logMAR] |
0.420
(0.0142)
|
0.510
(0.0163)
|
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 | -0.090 | |
| Confidence Interval |
(2-Sided) 95% -0.133 to -0.048 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.0216 |
|
| Estimation Comments | Least squares mean difference (DFT015 - SN60WF) | |
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population included all eyes successfully implanted that had at least 1 postoperative visit, no macular degeneration at any time, and no major protocol violations (Best-case Analysis Set). 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 | 151 | 104 |
| Measure Eyes | 151 | 104 |
| Number [diopter] |
1.61
|
1.09
|
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 | Mean difference in depth of focus |
| Estimated Value | 0.52 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Mean difference in depth of focus (DFT015 - SN60WF) | |
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All-Implanted 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 | 156 | 120 |
| Measure Eyes | 156 | 120 |
| Without Glare |
0.799
(0.0364)
|
0.978
(0.0413)
|
| With Glare |
0.794
(0.0357)
|
0.975
(0.0406)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DFT015, SN60WF |
|---|---|---|
| Comments | Without glare | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | Non-inferiority margin was -0.15 log unit | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -0.179 | |
| Confidence Interval |
(1-Sided) 97.5% -0.287 to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.0551 |
|
| Estimation Comments | Least squares mean difference (DFT015 - SN60WF). The 1-sided 97.5 Lower Limit Confidence Interval is presented. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | DFT015, SN60WF |
|---|---|---|
| Comments | With glare | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | Non-inferiority margin was -0.15 log unit | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -0.181 | |
| Confidence Interval |
(1-Sided) 97.5% -0.287 to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.0541 |
|
| Estimation Comments | Least squares mean difference (DFT015 - SN60WF). The 1-sided 97.5 Lower Limit Confidence Interval is presented. | |
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All-Implanted Analysis Set |
| 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 | 80 |
| Number [percentage of subjects] |
30.2
|
10.0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DFT015, SN60WF |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in percentage |
| Estimated Value | 20.2 | |
| Confidence Interval |
(2-Sided) 95% 8.77 to 31.04 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 95% CI for the difference (DFT015 - SN60WF) is estimated using Miettinen-Nurminen method (1985). | |
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All-Implanted Analysis Set |
| 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 | 80 |
| Number [percentage of subjects] |
75.5
|
53.8
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DFT015, SN60WF |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percent difference |
| Estimated Value | 21.7 | |
| Confidence Interval |
(2-Sided) 95% 7.92 to 35.06 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 95% CI for the difference (DFT015 - SN60WF) is estimated using Miettinen-Nurminen method (1985). | |
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 |
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| 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 | 0/276 (0%) | 0/156 (0%) | 0/154 (0%) | 0/156 (0%) | 0/120 (0%) | 0/119 (0%) | 0/120 (0%) | |||||||
Serious Adverse Events |
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| 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 | 1/276 (0.4%) | 2/156 (1.3%) | 2/154 (1.3%) | 3/156 (1.9%) | 2/120 (1.7%) | 0/119 (0%) | 9/120 (7.5%) | |||||||
| Cardiac disorders | ||||||||||||||
| Acute myocardial infarction | 0/276 (0%) | 0/156 (0%) | 0/154 (0%) | 0/156 (0%) | 0/120 (0%) | 0/119 (0%) | 1/120 (0.8%) | |||||||
| Eye disorders | ||||||||||||||
| Cystoid macular oedema | 0/276 (0%) | 1/156 (0.6%) | 0/154 (0%) | 0/156 (0%) | 1/120 (0.8%) | 0/119 (0%) | 0/120 (0%) | |||||||
| Posterior capsule rupture | 0/276 (0%) | 0/156 (0%) | 1/154 (0.6%) | 0/156 (0%) | 1/120 (0.8%) | 0/119 (0%) | 0/120 (0%) | |||||||
| Refraction disorder | 0/276 (0%) | 0/156 (0%) | 1/154 (0.6%) | 0/156 (0%) | 0/120 (0%) | 0/119 (0%) | 0/120 (0%) | |||||||
| Vitreous loss | 0/276 (0%) | 0/156 (0%) | 1/154 (0.6%) | 0/156 (0%) | 1/120 (0.8%) | 0/119 (0%) | 0/120 (0%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Ileus | 0/276 (0%) | 0/156 (0%) | 0/154 (0%) | 1/156 (0.6%) | 0/120 (0%) | 0/119 (0%) | 0/120 (0%) | |||||||
| Pancreatitis | 0/276 (0%) | 0/156 (0%) | 0/154 (0%) | 0/156 (0%) | 0/120 (0%) | 0/119 (0%) | 1/120 (0.8%) | |||||||
| Hepatobiliary disorders | ||||||||||||||
| Cholelithiasis | 0/276 (0%) | 0/156 (0%) | 0/154 (0%) | 1/156 (0.6%) | 0/120 (0%) | 0/119 (0%) | 0/120 (0%) | |||||||
| Infections and infestations | ||||||||||||||
| Cholecystitis infective | 0/276 (0%) | 0/156 (0%) | 0/154 (0%) | 0/156 (0%) | 0/120 (0%) | 0/119 (0%) | 1/120 (0.8%) | |||||||
| Influenza | 0/276 (0%) | 0/156 (0%) | 0/154 (0%) | 1/156 (0.6%) | 0/120 (0%) | 0/119 (0%) | 0/120 (0%) | |||||||
| Pneumonia | 1/276 (0.4%) | 0/156 (0%) | 0/154 (0%) | 0/156 (0%) | 0/120 (0%) | 0/119 (0%) | 1/120 (0.8%) | |||||||
| Injury, poisoning and procedural complications | ||||||||||||||
| Craniocerebral injury | 0/276 (0%) | 0/156 (0%) | 0/154 (0%) | 0/156 (0%) | 0/120 (0%) | 0/119 (0%) | 1/120 (0.8%) | |||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||
| Breast cancer metastatic | 0/276 (0%) | 0/156 (0%) | 0/154 (0%) | 0/156 (0%) | 0/120 (0%) | 0/119 (0%) | 1/120 (0.8%) | |||||||
| Nervous system disorders | ||||||||||||||
| Cerebral infarction | 0/276 (0%) | 0/156 (0%) | 0/154 (0%) | 0/156 (0%) | 0/120 (0%) | 0/119 (0%) | 1/120 (0.8%) | |||||||
| Syncope | 0/276 (0%) | 0/156 (0%) | 0/154 (0%) | 0/156 (0%) | 0/120 (0%) | 0/119 (0%) | 1/120 (0.8%) | |||||||
| Product Issues | ||||||||||||||
| Device dislocation | 0/276 (0%) | 1/156 (0.6%) | 0/154 (0%) | 0/156 (0%) | 0/120 (0%) | 0/119 (0%) | 0/120 (0%) | |||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| Chronic obstructive pulmonary disease | 0/276 (0%) | 0/156 (0%) | 0/154 (0%) | 0/156 (0%) | 0/120 (0%) | 0/119 (0%) | 1/120 (0.8%) | |||||||
| Surgical and medical procedures | ||||||||||||||
| Hip arthroplasty | 0/276 (0%) | 0/156 (0%) | 0/154 (0%) | 0/156 (0%) | 0/120 (0%) | 0/119 (0%) | 1/120 (0.8%) | |||||||
| Intraocular lens repositioning | 0/276 (0%) | 1/156 (0.6%) | 0/154 (0%) | 0/156 (0%) | 0/120 (0%) | 0/119 (0%) | 0/120 (0%) | |||||||
| Keratomileusis | 0/276 (0%) | 0/156 (0%) | 1/154 (0.6%) | 0/156 (0%) | 0/120 (0%) | 0/119 (0%) | 0/120 (0%) | |||||||
| Vitrectomy | 0/276 (0%) | 0/156 (0%) | 1/154 (0.6%) | 0/156 (0%) | 1/120 (0.8%) | 0/119 (0%) | 0/120 (0%) | |||||||
Other (Not Including Serious) Adverse Events |
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| 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 | 0/276 (0%) | 0/156 (0%) | 0/154 (0%) | 0/156 (0%) | 0/120 (0%) | 0/119 (0%) | 0/120 (0%) | |||||||
Limitations/Caveats
[Not Specified]
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 |
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT03010254
Other Study ID Numbers:
- ILI875-C001
First Posted:
Jan 5, 2017
Last Update Posted:
Apr 7, 2020
Last Verified:
Mar 1, 2020