A Comparison of the Checkup Vision Assessment System to Standard Vision Assessment Tools
CLEAR
The Correlation of the Checkup Vision Assessment System to Standard In Office Visual Assessment
1 other identifier
observational
143
1 country
12
Brief Summary
The CLEAR study is testing the level of agreement between visual acuity and Amsler grid testing using a mobile vision testing application, Checkup Study, and standard in office methods. In addition the percent of patients able to successfully complete home testing on the digital device will be assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2016
12 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
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 18, 2016
CompletedFirst Posted
Study publicly available on registry
August 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedJanuary 26, 2018
January 1, 2018
1.7 years
July 18, 2016
January 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Near Corrected Visual Acuity
Corrected Near Visual Acuity (CNVA) assessed with the Checkup System will be compared to the reference method CNVA (Lebensohn Near Card) in replicated measurements at each of two in-office visits.
Eight weeks
Amsler Grid
The Amsler Grid assessment with the Checkup will be compared to the reference method Amsler Grid in replicated measurements at each of two in-office visits
Eight weeks
Secondary Outcomes (2)
Feasibility of home testing using Paxos Checkup Mobile application
Eight weeks
Assess repeatability of mobile application testing
8 weeks
Study Arms (3)
Normal Vision
Patients without significant vision deficit (20/20 vision), when eligible and providing informed consent, assigned to evaluation with Paxos Checkup Study Mobile Medical Application
Age-related macular degeneration
Patients presenting with dry AMD or neovascular (wet) AMD, when eligible and providing informed consent, assigned to evaluation with Paxos Checkup Study Mobile Medical Application
Diabetic retinopathy
Patients presenting with Diabetic Retinopathy, when eligible and providing informed consent, assigned to evaluation with Paxos Checkup Study Mobile Medical Application
Interventions
The Digisight Paxos Checkup TM is mobile vision assessment system which consists of an application installed on a mobile device with an Internet connection, an Internet Cloud-based vision care network and a web site. The Paxos Checkup app contains a set of quantitative near vision tests, which a patient can take at home or elsewhere using an Internet capable mobile device.
Eligibility Criteria
Study population includes patients with no pathology, patients with Diabetic Retinopathy and patients with Adult Macular Degeneration.
You may qualify if:
- Male or female 18 years of age and older
- Best Corrected Near Visual acuity 20/200 or better in study eye(s)
- Able and willing to make the required study visits
- Able and willing to provide consent and comply with study assessments for the full duration of the study.
- Best Corrected Near Visual acuity 20/32 or better in each eye
- No concurrent systemic illness affecting the retina and vision.
- Diagnosis of either AMD or DR (all subgroups qualify)
You may not qualify if:
- Dementia or other neurologic or psychological limitation that would prevent the patient from performing regular self-testing of visual function
- Other comorbid ocular pathology affecting vision (with the exception of cataract, pseudophakia, refractive error, and/or presbyopia)
- Inability to successfully undergo training and certify ability to self-test with Paxos Checkup
- Inability to return for follow up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Mountain View, California, United States
Unknown Facility
Fort Myers, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Tallahassee, Florida, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Reno, Nevada, United States
Unknown Facility
Cleveland, Ohio, 44122, United States
Unknown Facility
Nashville, Tennessee, 37215, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Spokane, Washington, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Carol Hoang
Digisight Technologies, Inc.
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2016
First Posted
August 18, 2016
Study Start
July 1, 2016
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
January 26, 2018
Record last verified: 2018-01