Postmarket Study of an Intraocular Lens Power Selection System
Postmarket Study of ORA With VerifEye+ and Barrett Toric Calculator Used for the Implantation of AcrySof Toric
1 other identifier
interventional
124
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2018
Shorter than P25 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2018
CompletedFirst Posted
Study publicly available on registry
July 6, 2018
CompletedStudy Start
First participant enrolled
August 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 16, 2019
CompletedResults Posted
Study results publicly available
April 7, 2020
CompletedApril 7, 2020
April 1, 2020
8 months
June 26, 2018
March 23, 2020
April 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Month 6
Study Arms (2)
ORA with VerifEye+
EXPERIMENTALFirst 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.
Barrett Toric Calculator
ACTIVE COMPARATORFirst 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.
Interventions
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.
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.
Intraocular lens implanted as a replacement for the cataractous lens during cataract surgery (Model SN6AT3, SN6AT4, Model SN6AT5, Model SN6AT6)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (9)
Alcon Investigative Site
Mt. Dora, Florida, 32757, United States
Alcon Investigative Site
Panama City, Florida, 32405, United States
Alcon Investigative Site
Poughkeepsie, New York, 12603, United States
Alcon Investigative Site
Kingston, Pennsylvania, 18704, United States
Alcon Investigative Site
Florence, South Carolina, 29501, United States
Alcon Investigative Site
Mt. Pleasant, South Carolina, 29464, United States
Alcon Investigative Site
Sioux Falls, South Dakota, 57108, United States
Alcon Investigative Site
Nashville, Tennessee, 37205, United States
Alcon Investigative Site
Nacogdoches, Texas, 75965, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. CDMA Project Lead, Surgical
- Organization
- Alcon Research, LLC
Study Officials
- STUDY DIRECTOR
Clinical Operations Lead, Surgical
Alcon Research, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2018
First Posted
July 6, 2018
Study Start
August 16, 2018
Primary Completion
April 16, 2019
Study Completion
April 16, 2019
Last Updated
April 7, 2020
Results First Posted
April 7, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share