- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01510717
Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0]
May 8, 2015 updated by: Alcon Research
Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
409
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Multifocal IOL
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation
|
Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient
|
Active Comparator: Monofocal IOL
AcrySof® IQ Monofocal IOL Model SN60WF, bilateral implantation
|
Monofocal IOL implanted for long-term use over the lifetime of the cataract patient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180
Time Frame: Day 120-180 from second eye implantation
|
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.
|
Day 120-180 from second eye implantation
|
Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180
Time Frame: Day 0 first operative eye visit, up to Day 120-180 from second eye implantation
|
Cumulative and persistent adverse events were collected.
This outcome measure was prespecified for the multifocal IOL.
|
Day 0 first operative eye visit, up to Day 120-180 from second eye implantation
|
Photopic Contrast Sensitivity Without Glare at Day 120-180
Time Frame: Day 120-180 from second eye implantation
|
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.
|
Day 120-180 from second eye implantation
|
Photopic Contrast Sensitivity With Glare at Day 120-180
Time Frame: Day 120-180 from second eye implantation
|
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.
|
Day 120-180 from second eye implantation
|
Mesopic Contrast Sensitivity Without Glare at Day 120-180
Time Frame: Day 120-180 from second eye implantation
|
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.
|
Day 120-180 from second eye implantation
|
Mesopic Contrast Sensitivity With Glare at Day 120-180
Time Frame: Day 120-180 from second eye implantation
|
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.
|
Day 120-180 from second eye implantation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180
Time Frame: Day 120-180 from second eye implantation
|
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.
|
Day 120-180 from second eye implantation
|
Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180
Time Frame: Day 120-180 from second eye implantation
|
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.
|
Day 120-180 from second eye implantation
|
Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180
Time Frame: Day 120-180 from second eye implantation
|
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?"
|
Day 120-180 from second eye implantation
|
Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180
Time Frame: Day 120-180 from second eye implantation
|
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?"
|
Day 120-180 from second eye implantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Magda Michna, PhD, Alcon Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
January 12, 2012
First Submitted That Met QC Criteria
January 12, 2012
First Posted (Estimate)
January 16, 2012
Study Record Updates
Last Update Posted (Estimate)
May 27, 2015
Last Update Submitted That Met QC Criteria
May 8, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-10-016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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