Back to resultsA Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting Intraocular Lenses (IOLs)
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT
Acri.LISA® 366D IOL
Acri.LISA® 466TD Toric IOL
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Intraocular Lens, Presbyopia, multifocal
Eligibility Criteria
Inclusion Criteria:
- Sign informed consent;
- Able to attend postoperative examinations per protocol schedule;
- Diagnosed with bilateral cataracts;
- Planned cataract removal by phacoemulsification with implantation of an intraocular lens (IOL);
- Preoperative astigmatism ≤ 2.5 diopter;
- Good ocular health, with the exception of cataracts;
- Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and Acri.LISA package inserts;
- Able to undergo second eye surgery within one month of the first eye surgery;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Previous corneal surgery;
- Planned multiple procedures during cataract/IOL implantation surgery;
- Any ocular disease and/or condition that may compromise study results;
- Pregnant or planning pregnancy during course of study;
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
- Diabetic retinopathy;
- Macular degeneration;
- History of retinal detachment;
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ReSTOR +3
Acri.LISA
Arm Description
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
Outcomes
Primary Outcome Measures
Mean Binocular Defocus VA at Month 3
Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in logarithm of the minimum angle of resolution (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.
Secondary Outcome Measures
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3
Visual acuity (VA) was tested binocularly (both eyes together) with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (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.
Uncorrected Visual Acuity Across a Range of Distances at Month 3
VA was tested binocularly unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (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.
Mean Refractive Spherical Equivalent at Month 3
A manifest refraction (vision check) was performed using a 100% contrast ETDRS chart under well-lit conditions. Results were documented for sphere, cylinder and axis readings. The refractive spherical equivalent was calculated according to the formula: sphere + ½ cylinder power. Both eyes contributed to the mean.
Mean Radner Reading Speed
Reading performance was measured using the Radner Reading Chart with no correction (without) and with best distance corrective aids (with). Reading speed was measured in words per minute.
Patient Reported Outcomes at Month 3
The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Tasks were rated using a 1 to 5 point scale, where 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish. Individual scores for each task were averaged to obtain the overall score for each vision type/function. Near vision was defined as less than 50 cm; intermediate vision as 50 cm to 1 m; extended intermediate vision as 90 cm to 4 m; and distant vision as more than 4 m.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01257217
Brief Title
A Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting Intraocular Lenses (IOLs)
Official Title
A Randomized, Subject-Masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting IOLs
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (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 evaluate visual and refractive parameters in a series of subjects bilaterally implanted with presbyopia-correcting intraocular lenses (IOLs) during cataract surgery.
Detailed Description
Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 4 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1 and Month 3 after the second implantation). The second implantation occurred within 30 days of the first.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Intraocular Lens, Presbyopia, multifocal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ReSTOR +3
Arm Type
Experimental
Arm Description
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
Arm Title
Acri.LISA
Arm Type
Active Comparator
Arm Description
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
Intervention Type
Device
Intervention Name(s)
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1
Intervention Description
Multifocal IOL implanted for long-term use over the lifetime of the cataract patient
Intervention Type
Device
Intervention Name(s)
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT
Other Intervention Name(s)
Models SND1T2, SND1T3, SND1T4, SND1T5, SND1T6
Intervention Description
Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
Intervention Type
Device
Intervention Name(s)
Acri.LISA® 366D IOL
Intervention Description
Aspheric diffractive IOL with +3.75 D add power implanted for long-term use over the lifetime of the cataract patient
Intervention Type
Device
Intervention Name(s)
Acri.LISA® 466TD Toric IOL
Intervention Description
Aspheric diffractive IOL with +3.75 D add power and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
Primary Outcome Measure Information:
Title
Mean Binocular Defocus VA at Month 3
Description
Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in logarithm of the minimum angle of resolution (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.
Time Frame
Month 3 from second eye implantation
Secondary Outcome Measure Information:
Title
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3
Description
Visual acuity (VA) was tested binocularly (both eyes together) with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (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.
Time Frame
Month 3 from second eye implantation
Title
Uncorrected Visual Acuity Across a Range of Distances at Month 3
Description
VA was tested binocularly unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (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.
Time Frame
Month 3 from second eye implantation
Title
Mean Refractive Spherical Equivalent at Month 3
Description
A manifest refraction (vision check) was performed using a 100% contrast ETDRS chart under well-lit conditions. Results were documented for sphere, cylinder and axis readings. The refractive spherical equivalent was calculated according to the formula: sphere + ½ cylinder power. Both eyes contributed to the mean.
Time Frame
Month 3 from second eye implantation
Title
Mean Radner Reading Speed
Description
Reading performance was measured using the Radner Reading Chart with no correction (without) and with best distance corrective aids (with). Reading speed was measured in words per minute.
Time Frame
Month 3 from second eye implantation
Title
Patient Reported Outcomes at Month 3
Description
The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Tasks were rated using a 1 to 5 point scale, where 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish. Individual scores for each task were averaged to obtain the overall score for each vision type/function. Near vision was defined as less than 50 cm; intermediate vision as 50 cm to 1 m; extended intermediate vision as 90 cm to 4 m; and distant vision as more than 4 m.
Time Frame
Month 3 from second eye implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sign informed consent;
Able to attend postoperative examinations per protocol schedule;
Diagnosed with bilateral cataracts;
Planned cataract removal by phacoemulsification with implantation of an intraocular lens (IOL);
Preoperative astigmatism ≤ 2.5 diopter;
Good ocular health, with the exception of cataracts;
Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and Acri.LISA package inserts;
Able to undergo second eye surgery within one month of the first eye surgery;
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Previous corneal surgery;
Planned multiple procedures during cataract/IOL implantation surgery;
Any ocular disease and/or condition that may compromise study results;
Pregnant or planning pregnancy during course of study;
History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
Diabetic retinopathy;
Macular degeneration;
History of retinal detachment;
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brand Lead, Surgical, Global Medical Affairs
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting Intraocular Lenses (IOLs)
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