Back to resultsPilot Study of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring intraocular lens, multifocal, toric
Eligibility Criteria
Inclusion Criteria:
- Sign informed consent;
- Require cataract extraction followed by posterior IOL implantation or eligible for refractive lens exchange (RLE) in both eyes;
- Able to undergo second eye surgery within one month (30 days) of first eye surgery;
- Able to attend postoperative examinations per protocol schedule;
- Qualify for a AcrySof IQ Toric IOL in both eyes;
- Preoperative astigmatism of ≥0.75 to ≤2.5 diopters (D) in both eyes;
- Residual refractive cylinder of ≤0.5 D in both eyes;
- Good ocular health;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Planned multiple procedures, including LRI, during cataract/IOL implantation surgery;
- Amblyopia;
- Previous corneal surgery;
- Clinically significant corneal endothelial dystrophy;
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.);
- History of retinal detachment;
- Pregnant or planning to become pregnant during course of study;
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ReSTOR +3.0
Arm Description
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
Outcomes
Primary Outcome Measures
Uncorrected Visual Acuity Across a Range of Distances at Month 6
Visual acuity (VA) was tested binocularly (both eyes together) 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.
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6
VA was tested binocularly 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.
Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6
Manifest refraction was performed under well-lit conditions using an ETDRS chart. The subject was manually refracted to his/her best correction by an outcomes assessor using a phoropter or trial lenses. Manifest refraction was performed for each eye. Proportion of subjects that achieved spherical equivalent within ± 0.5D/ ± 0.75D/ ± 1.0D at Month 6 is reported as percentage of subjects.
Secondary Outcome Measures
Patient Reported Outcomes at Month 6
The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Distance specific tasks were rated (without / with corrective aids) 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
NCT01200511
Brief Title
Pilot Study of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)
Official Title
A Prospective Pilot Clinical Study of the AcrySof® IQ ReSTOR® Multifocal Toric IOL
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 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 describe visual outcomes, in particular spherical equivalent by manifest refraction and visual acuity across a range of distances, 6 months post implantation of the AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL in adult patients with corneal astigmatism. Additionally, patient reported outcomes will be assessed.
Detailed Description
Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 5 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1, Month 3, and Month 6 after the second implantation). The second implantation generally 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, multifocal, toric
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ReSTOR +3.0
Arm Type
Experimental
Arm Description
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
Intervention Type
Device
Intervention Name(s)
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
Other Intervention Name(s)
Models SND1T3, SND1T4, SND1T5
Intervention Description
Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
Primary Outcome Measure Information:
Title
Uncorrected Visual Acuity Across a Range of Distances at Month 6
Description
Visual acuity (VA) was tested binocularly (both eyes together) 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 6 from second eye implantation
Title
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6
Description
VA was tested binocularly 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 6 from second eye implantation
Title
Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6
Description
Manifest refraction was performed under well-lit conditions using an ETDRS chart. The subject was manually refracted to his/her best correction by an outcomes assessor using a phoropter or trial lenses. Manifest refraction was performed for each eye. Proportion of subjects that achieved spherical equivalent within ± 0.5D/ ± 0.75D/ ± 1.0D at Month 6 is reported as percentage of subjects.
Time Frame
Month 6 from second eye implantation
Secondary Outcome Measure Information:
Title
Patient Reported Outcomes at Month 6
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. Distance specific tasks were rated (without / with corrective aids) 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 6 from second eye implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sign informed consent;
Require cataract extraction followed by posterior IOL implantation or eligible for refractive lens exchange (RLE) in both eyes;
Able to undergo second eye surgery within one month (30 days) of first eye surgery;
Able to attend postoperative examinations per protocol schedule;
Qualify for a AcrySof IQ Toric IOL in both eyes;
Preoperative astigmatism of ≥0.75 to ≤2.5 diopters (D) in both eyes;
Residual refractive cylinder of ≤0.5 D in both eyes;
Good ocular health;
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Planned multiple procedures, including LRI, during cataract/IOL implantation surgery;
Amblyopia;
Previous corneal surgery;
Clinically significant corneal endothelial dystrophy;
History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.);
History of retinal detachment;
Pregnant or planning to become pregnant during course of study;
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
Pilot Study of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)
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