Back to resultsA Comparison of Corneal Aberrations in Subjects With Contralateral AcrySof IQ Toric Intraocular Lens (IOL) and AcrySof IQ IOL With Limbal Relaxing Incision (LRI)
Primary Purpose
Cataract, Astigmatism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AcrySof IQ Toric IOL
AcrySof IQ Aspheric IOL
Limbal Relaxing Incision (LRI)
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Cataract, Toric, IOL, AcrySof, LRI, Astigmatism
Eligibility Criteria
Inclusion Criteria:
Ocular criteria must be met in both eyes.
- Willing and able to understand and sign an informed consent;
- Willing and able to attend postoperative examinations per protocol schedule;
- Have cataracts that require extraction followed by implantation of a posterior chamber intraocular lens and used as an on-label procedure;
- Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and AcrySof IQ Toric package inserts;
- Have regular, bowtie shaped corneal astigmatism and qualify for an SN6AT3, SN6AT4 or SN6AT5 Intraocular Lens (IOL) in both eyes;
- Have the second surgery at least one week following the first eye implant but not later than one month after the first implant.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Previous corneal surgery;
- Planned multiple procedures during cataract/IOL implantation surgery;
- Ocular disease and/or condition that may compromise study results;
- Pregnant or planning pregnancy during course of study;
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Contact Alcon Call Center for Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IQ Toric IOL
IQ Aspheric IOL + LRI
Arm Description
AcrySof IQ Toric intraocular lens (IOL) randomly assigned to one eye, with AcrySof IQ Aspheric IOL with Limbal Relaxing Incision (LRI) procedure in the fellow eye for contralateral implantation.
AcrySof IQ Aspheric intraocular lens (IOL) with Limbal Relaxing Incision (LRI) procedure randomly assigned to one eye, with AcrySof IQ Toric IOL in the fellow eye for contralateral implantation
Outcomes
Primary Outcome Measures
Corneal Aberration
Secondary Outcome Measures
Visual Acuity
Corneal Cylinder
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01045733
Brief Title
A Comparison of Corneal Aberrations in Subjects With Contralateral AcrySof IQ Toric Intraocular Lens (IOL) and AcrySof IQ IOL With Limbal Relaxing Incision (LRI)
Official Title
A Prospective Contralateral Comparison of Corneal Aberrations in Subjects Undergoing Aspheric Lens Implantation With Concomitant LRI and Aspheric Toric IOL Implantation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 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 was to evaluate and compare postoperative corneal aberrations and visual parameters in patients contralaterally implanted with an AcrySof IQ Toric intraocular lens (IOL) and AcrySof IQ Aspheric IOL with concomitant limbal relaxing incision.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Astigmatism
Keywords
Cataract, Toric, IOL, AcrySof, LRI, Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IQ Toric IOL
Arm Type
Experimental
Arm Description
AcrySof IQ Toric intraocular lens (IOL) randomly assigned to one eye, with AcrySof IQ Aspheric IOL with Limbal Relaxing Incision (LRI) procedure in the fellow eye for contralateral implantation.
Arm Title
IQ Aspheric IOL + LRI
Arm Type
Active Comparator
Arm Description
AcrySof IQ Aspheric intraocular lens (IOL) with Limbal Relaxing Incision (LRI) procedure randomly assigned to one eye, with AcrySof IQ Toric IOL in the fellow eye for contralateral implantation
Intervention Type
Device
Intervention Name(s)
AcrySof IQ Toric IOL
Other Intervention Name(s)
AcrySof IQ Toric IOL Model SN6AT3, AcrySof IQ Toric IOL Model SN6AT4, AcrySof IQ Toric IOL Model SN6AT5
Intervention Description
AcrySof IQ Toric intraocular lens implanted in the capsular bag of the eye during cataract surgery. The IOL is intended for the lifetime of the patient.
Intervention Type
Device
Intervention Name(s)
AcrySof IQ Aspheric IOL
Other Intervention Name(s)
AcrySof IQ Aspheric IOL Model SN60WF
Intervention Description
AcrySof IQ aspheric intraocular lens implanted in the capsular bag of the eye during cataract surgery. The IOL is intended for the lifetime of the patient.
Intervention Type
Procedure
Intervention Name(s)
Limbal Relaxing Incision (LRI)
Intervention Description
An incision was made at the corneal-limbal junction during cataract surgery for the purpose of relaxing corneal curvature, ie., correcting astigmatism.
Primary Outcome Measure Information:
Title
Corneal Aberration
Time Frame
Month 6 postoperative
Secondary Outcome Measure Information:
Title
Visual Acuity
Time Frame
Month 6 postoperative
Title
Corneal Cylinder
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ocular criteria must be met in both eyes.
Willing and able to understand and sign an informed consent;
Willing and able to attend postoperative examinations per protocol schedule;
Have cataracts that require extraction followed by implantation of a posterior chamber intraocular lens and used as an on-label procedure;
Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and AcrySof IQ Toric package inserts;
Have regular, bowtie shaped corneal astigmatism and qualify for an SN6AT3, SN6AT4 or SN6AT5 Intraocular Lens (IOL) in both eyes;
Have the second surgery at least one week following the first eye implant but not later than one month after the first implant.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Previous corneal surgery;
Planned multiple procedures during cataract/IOL implantation surgery;
Ocular disease and/or condition that may compromise study results;
Pregnant or planning pregnancy during course of study;
Other protocol-defined exclusion criteria may apply.
Facility Information:
Facility Name
Contact Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Corneal Aberrations in Subjects With Contralateral AcrySof IQ Toric Intraocular Lens (IOL) and AcrySof IQ IOL With Limbal Relaxing Incision (LRI)
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