Back to resultsClinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0]
Primary Purpose
Cataracts
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
AcrySof® IQ Monofocal IOL Model SN60WF
Sponsored by
About this trial
This is an interventional treatment trial for Cataracts focused on measuring Intraocular Lens, Monofocal, Multifocal
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of bilateral cataracts
- Willing and able to complete all required postoperative visits
- Calculated lens power within the available supply range
- Planned cataract removal by phacoemulsification
- Potential postoperative visual acuity of 0.2 logMAR or better in both eyes
- Preoperative astigmatism less than 1.0 diopter
- Clear intraocular media other than cataract in study eyes
- Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR
- Able to undergo second eye surgery between 7 days and 30 days of the first eye surgery
- Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
- Previous refractive surgery
- Inflammation or edema of the cornea
- Optic nerve atrophy
- Pregnancy
- Current participation in another investigational drug or device study
- Other protocol-defined exclusion criteria may apply
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Multifocal IOL
Monofocal IOL
Arm Description
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation
AcrySof® IQ Monofocal IOL Model SN60WF, bilateral implantation
Outcomes
Primary Outcome Measures
Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180
Visual acuity (VA) was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 53 centimeters (cm) on the nearpoint rod. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.
Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180
Cumulative and persistent adverse events were collected. This outcome measure was prespecified for the multifocal IOL.
Photopic Contrast Sensitivity Without Glare at Day 120-180
Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.
Photopic Contrast Sensitivity With Glare at Day 120-180
Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.
Mesopic Contrast Sensitivity Without Glare at Day 120-180
Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic (dim lighting) conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.
Mesopic Contrast Sensitivity With Glare at Day 120-180
Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.
Secondary Outcome Measures
Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180
VA was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast, ETDRS charts at a distance of 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.
Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180
VA was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.
Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180
Overall Spectacle Independence was rated using SILVER (Spectacle Independence Lens Vision Evaluation and Repurchase), a new patient reported outcome questionnaire. The participant was asked, "How often do you wear eyeglasses or contact lenses overall?"
Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180
Near Spectacle Independence was rated using SILVER, a new patient reported outcome questionnaire. The participant was asked, "How often do you wear eyeglasses or contact lenses for seeing objects up close?"
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01510717
Brief Title
Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0]
Official Title
Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the safety and efficacy of an investigational multifocal intraocular lens (IOL) to an FDA-approved monofocal IOL.
Detailed Description
Participants 21 years and older in need of cataract extraction were consented and randomized in a 1:1 ratio at each investigative site to receive either the AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] or the AcrySof® IQ Monofocal IOL Model SN60WF in both eyes. Each participant completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 7 postoperative visits, with monocular testing at Day 1-2, Day 7-14, and Day 30-60, and monocular and binocular testing at Day 120-180 following the second implantation. The first eye to be implanted was considered the primary eye. The second eye was implanted 7 and 30 days of the first. If the first eye was not implanted during surgery, the second eye was not eligible. If the second eye was not implanted during surgery, only the first eye was followed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts
Keywords
Intraocular Lens, Monofocal, Multifocal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
409 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multifocal IOL
Arm Type
Experimental
Arm Description
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation
Arm Title
Monofocal IOL
Arm Type
Active Comparator
Arm Description
AcrySof® IQ Monofocal IOL Model SN60WF, bilateral implantation
Intervention Type
Device
Intervention Name(s)
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
Intervention Description
Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient
Intervention Type
Device
Intervention Name(s)
AcrySof® IQ Monofocal IOL Model SN60WF
Intervention Description
Monofocal IOL implanted for long-term use over the lifetime of the cataract patient
Primary Outcome Measure Information:
Title
Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180
Description
Visual acuity (VA) was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 53 centimeters (cm) on the nearpoint rod. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.
Time Frame
Day 120-180 from second eye implantation
Title
Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180
Description
Cumulative and persistent adverse events were collected. This outcome measure was prespecified for the multifocal IOL.
Time Frame
Day 0 first operative eye visit, up to Day 120-180 from second eye implantation
Title
Photopic Contrast Sensitivity Without Glare at Day 120-180
Description
Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.
Time Frame
Day 120-180 from second eye implantation
Title
Photopic Contrast Sensitivity With Glare at Day 120-180
Description
Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.
Time Frame
Day 120-180 from second eye implantation
Title
Mesopic Contrast Sensitivity Without Glare at Day 120-180
Description
Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic (dim lighting) conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.
Time Frame
Day 120-180 from second eye implantation
Title
Mesopic Contrast Sensitivity With Glare at Day 120-180
Description
Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.
Time Frame
Day 120-180 from second eye implantation
Secondary Outcome Measure Information:
Title
Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180
Description
VA was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast, ETDRS charts at a distance of 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.
Time Frame
Day 120-180 from second eye implantation
Title
Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180
Description
VA was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.
Time Frame
Day 120-180 from second eye implantation
Title
Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180
Description
Overall Spectacle Independence was rated using SILVER (Spectacle Independence Lens Vision Evaluation and Repurchase), a new patient reported outcome questionnaire. The participant was asked, "How often do you wear eyeglasses or contact lenses overall?"
Time Frame
Day 120-180 from second eye implantation
Title
Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180
Description
Near Spectacle Independence was rated using SILVER, a new patient reported outcome questionnaire. The participant was asked, "How often do you wear eyeglasses or contact lenses for seeing objects up close?"
Time Frame
Day 120-180 from second eye implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of bilateral cataracts
Willing and able to complete all required postoperative visits
Calculated lens power within the available supply range
Planned cataract removal by phacoemulsification
Potential postoperative visual acuity of 0.2 logMAR or better in both eyes
Preoperative astigmatism less than 1.0 diopter
Clear intraocular media other than cataract in study eyes
Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR
Able to undergo second eye surgery between 7 days and 30 days of the first eye surgery
Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
Previous refractive surgery
Inflammation or edema of the cornea
Optic nerve atrophy
Pregnancy
Current participation in another investigational drug or device study
Other protocol-defined exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magda Michna, PhD
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
32600261
Citation
Williams JR, Kim HW, Crespi CM. Modeling observations with a detection limit using a truncated normal distribution with censoring. BMC Med Res Methodol. 2020 Jun 29;20(1):170. doi: 10.1186/s12874-020-01032-9.
Results Reference
derived
Learn more about this trial
Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0]
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