Cataract
Conditions
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.
Interventions
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
Monofocal IOL implanted for long-term use over the lifetime of the pseudophakic subject
PROCEDURECataract surgery
IOL bilateral implantation
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Australia, Canada, Spain, United Kingdom
Participant flow
Recruitment details
Subjects were recruited from 21 investigative sites located in Australia, Canada, Spain and the United Kingdom.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| DFT015 ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation | 156 |
| SN60WF ACRYSOF® IQ Monofocal IOL, bilateral implantation | 120 |
| Total | 276 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 4 | 0 |
| Overall Study | Other | 2 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | SN60WF | Total | DFT015 |
|---|---|---|---|
| Age, Continuous | 69.7 years STANDARD_DEVIATION 7.54 | 69.7 years STANDARD_DEVIATION 7.43 | 69.7 years STANDARD_DEVIATION 7.37 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 56 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 79 Participants | 186 Participants | 107 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 16 Participants | 34 Participants | 18 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 20 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 20 Participants | 10 Participants |
| Race (NIH/OMB) White | 101 Participants | 230 Participants | 129 Participants |
| Sex: Female, Male Female | 65 Participants | 159 Participants | 94 Participants |
| Sex: Female, Male Male | 55 Participants | 117 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 276 | 0 / 156 | 0 / 154 | 0 / 156 | 0 / 120 | 0 / 119 | 0 / 120 |
| other Total, other adverse events | 0 / 276 | 0 / 156 | 0 / 154 | 0 / 156 | 0 / 120 | 0 / 119 | 0 / 120 |
| serious Total, serious adverse events | 1 / 276 | 2 / 156 | 2 / 154 | 3 / 156 | 2 / 120 | 0 / 119 | 9 / 120 |
Outcome results
Primary
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.
Time frame: Month 3 (70-100 days post second eye implantation)
Population: All-Implanted Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DFT015 | Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeters (cm) | 0.175 logMAR | Standard Error 0.0137 |
| SN60WF | Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeters (cm) | 0.313 logMAR | Standard Error 0.0158 |
p-value: <0.00195% CI: [-0.18, -0.097]t-test, 2 sided
Primary
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.
Time frame: Day 0 (first operative eye visit) up to Month 6 (120-180 days post second eye implantation)
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Cumulative: Lens dislocated from posterior chamber | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Cumulative: Secondary surgical intervention | 0.6 percentage of subjects |
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Cumulative: Endophthalmitis | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Persistent: Corneal stroma oedema | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Cumulative: Pupillary block | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Persistent: Cystoid macular oedema | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Cumulative: Hypopyon | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Persistent: Iritis | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Cumulative: Retinal detachment | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Persistent: Raised IOP requiring treatment | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Cumulative: Cystoid macular oedema | 0.6 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Persistent: Raised IOP requiring treatment | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Cumulative: Cystoid macular oedema | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Cumulative: Hypopyon | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Cumulative: Endophthalmitis | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Cumulative: Lens dislocated from posterior chamber | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Cumulative: Pupillary block | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Cumulative: Retinal detachment | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Cumulative: Secondary surgical intervention | 0.6 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Persistent: Corneal stroma oedema | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Persistent: Cystoid macular oedema | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Persistent: Iritis | 0.0 percentage of subjects |
Secondary
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.
Time frame: Month 6 (120-180 days post second eye implantation)
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| DFT015 | Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd) | Without Glare | 0.799 log unit | Standard Error 0.0364 |
| DFT015 | Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd) | With Glare | 0.794 log unit | Standard Error 0.0357 |
| SN60WF | Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd) | Without Glare | 0.978 log unit | Standard Error 0.0413 |
| SN60WF | Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd) | With Glare | 0.975 log unit | Standard Error 0.0406 |
Comparison: Without glare
Comparison: With glare
Secondary
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.
Time frame: Month 3 (70-100 days post second eye implantation)
Population: All-Implanted Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DFT015 | Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters (m) | -0.007 logMAR | Standard Error 0.0076 |
| SN60WF | Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters (m) | -0.044 logMAR | Standard Error 0.0087 |
Secondary
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.
Time frame: Month 3 (70-100 days post second eye implantation)
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| DFT015 | Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve | 1.61 diopter |
| SN60WF | Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve | 1.09 diopter |
Secondary
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.
Time frame: Month 3 (70-100 days post second eye implantation)
Population: All-Implanted Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DFT015 | Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm | 0.420 logMAR | Standard Error 0.0142 |
| SN60WF | Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm | 0.510 logMAR | Standard Error 0.0163 |
p-value: <0.00195% CI: [-0.133, -0.048]t-test, 2 sided
Secondary
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.
Time frame: Month 6 (120-180 days post second eye implantation)
Population: All-Implanted Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DFT015 | Percentage of Subjects Who Respond Never to Question 1 of the Spectacle Use Questionnaire: How Often Do You Wear Eyeglasses for Any Purpose? | 30.2 percentage of subjects |
| SN60WF | Percentage of Subjects Who Respond Never to Question 1 of the Spectacle Use Questionnaire: How Often Do You Wear Eyeglasses for Any Purpose? | 10.0 percentage of subjects |
95% CI: [8.77, 31.04]
Secondary
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.
Time frame: Month 6 (120-180 days post second eye implantation)
Population: All-Implanted Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DFT015 | 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)? | 75.5 percentage of subjects |
| SN60WF | 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)? | 53.8 percentage of subjects |
95% CI: [7.92, 35.06]