Back to resultsPostmarket Study of an Intraocular Lens Power Selection System
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ORA with VerifEye+
Alcon Barrett Toric Calculator
Acrysof® IQ Toric IOL
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring IOL, Intraocular lens, Astigmatism, Cataract Surgery
Eligibility Criteria
Inclusion Criteria:
- Planned cataract surgery with IOL implantation
- Able to comprehend and sign the informed consent form
- Preoperative astigmatism of 0.75 to 3.00 Diopter
- Willing and able to complete all required postoperative visits
- Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
- Unclear intraocular media other than cataract
- Pregnant or lactating
- Presence or history of any condition or finding that makes the subject unsuitable as a candidate for cataract surgery or study participation or may confound the outcome of the study, in the opinion of the Investigator.
- Other protocol-defined exclusion criteria may apply
Sites / Locations
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ORA with VerifEye+
Barrett Toric Calculator
Arm Description
First surgical eye randomly assigned to Acrysof® IQ Toric IOL and ORA with VerifEye+ or Acrysof® IQ Toric IOL and Barrett Toric Calculator, with the second surgical eye (fellow eye) assigned to the alternative group.
First surgical eye randomly assigned to Acrysof® IQ Toric IOL and ORA with VerifEye+ or Acrysof® IQ Toric IOL and Barrett Toric Calculator, with the second surgical eye (fellow eye) assigned to the alternative group.
Outcomes
Primary Outcome Measures
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better at Month 6
Visual acuity (VA) was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. 20/20 represents normal distance eyesight. No hypothesis testing of the primary endpoint was specified.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03579433
Brief Title
Postmarket Study of an Intraocular Lens Power Selection System
Official Title
Postmarket Study of ORA With VerifEye+ and Barrett Toric Calculator Used for the Implantation of AcrySof Toric
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 16, 2018 (Actual)
Primary Completion Date
April 16, 2019 (Actual)
Study Completion Date
April 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study was to evaluate the visual acuity outcomes when using the Optiwave Refractive Analysis (ORA) with VerifEye+ and Barrett Toric Calculator for calculating intraocular lens (IOL) power and axis in subjects requiring cataract surgery and implanted with a toric IOL in both eyes.
Detailed Description
Surgery was done on each eye on different days, 7 to 14 days apart. Subjects were seen for a total of 10 visits with a follow-up duration of 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
IOL, Intraocular lens, Astigmatism, Cataract Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ORA with VerifEye+
Arm Type
Experimental
Arm Description
First surgical eye randomly assigned to Acrysof® IQ Toric IOL and ORA with VerifEye+ or Acrysof® IQ Toric IOL and Barrett Toric Calculator, with the second surgical eye (fellow eye) assigned to the alternative group.
Arm Title
Barrett Toric Calculator
Arm Type
Active Comparator
Arm Description
First surgical eye randomly assigned to Acrysof® IQ Toric IOL and ORA with VerifEye+ or Acrysof® IQ Toric IOL and Barrett Toric Calculator, with the second surgical eye (fellow eye) assigned to the alternative group.
Intervention Type
Device
Intervention Name(s)
ORA with VerifEye+
Intervention Description
Intraoperative device that measures total corneal astigmatism in the aphakic condition and is used for the selection of IOL power. In the pseudophakic condition, ORA provides guidance for the alignment of the toric axis mark.
Intervention Type
Other
Intervention Name(s)
Alcon Barrett Toric Calculator
Intervention Description
Web-based software application that utilizes an algorithm (Barrett Formula) to estimate the amount of post-operative corneal astigmatism in order to optimize IOL model selection and axis placement, with interoperative axis alignment done manually.
Intervention Type
Device
Intervention Name(s)
Acrysof® IQ Toric IOL
Intervention Description
Intraocular lens implanted as a replacement for the cataractous lens during cataract surgery (Model SN6AT3, SN6AT4, Model SN6AT5, Model SN6AT6)
Primary Outcome Measure Information:
Title
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better at Month 6
Description
Visual acuity (VA) was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. 20/20 represents normal distance eyesight. No hypothesis testing of the primary endpoint was specified.
Time Frame
Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Planned cataract surgery with IOL implantation
Able to comprehend and sign the informed consent form
Preoperative astigmatism of 0.75 to 3.00 Diopter
Willing and able to complete all required postoperative visits
Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
Unclear intraocular media other than cataract
Pregnant or lactating
Presence or history of any condition or finding that makes the subject unsuitable as a candidate for cataract surgery or study participation or may confound the outcome of the study, in the opinion of the Investigator.
Other protocol-defined exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Operations Lead, Surgical
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
Mount Dora
State/Province
Florida
ZIP/Postal Code
32757
Country
United States
Facility Name
Alcon Investigative Site
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Alcon Investigative Site
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12603
Country
United States
Facility Name
Alcon Investigative Site
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Alcon Investigative Site
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States
Facility Name
Alcon Investigative Site
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Alcon Investigative Site
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Alcon Investigative Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Alcon Investigative Site
City
Nacogdoches
State/Province
Texas
ZIP/Postal Code
75965
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Postmarket Study of an Intraocular Lens Power Selection System
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