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A Comparison of the Checkup Vision Assessment System to Standard Vision Assessment Tools (CLEAR)

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ClinicalTrials.gov Identifier: NCT02871817
Recruitment Status : Active, not recruiting
First Posted : August 18, 2016
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Digisight Technologies, Inc.

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.

Condition or disease Intervention/treatment
Age - Related Macular Degeneration Diabetic Retinopathy Metamorphopsia Other: Paxos Checkup Study Mobile Medical Application

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 143 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Correlation of the Checkup Vision Assessment System to Standard In Office Visual Assessment
Actual Study Start Date : July 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Other: Paxos Checkup Study Mobile Medical Application
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.
Other Name: Checkup Study

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
Other: Paxos Checkup Study Mobile Medical Application
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.
Other Name: Checkup Study

Diabetic retinopathy
Patients presenting with Diabetic Retinopathy, when eligible and providing informed consent, assigned to evaluation with Paxos Checkup Study Mobile Medical Application
Other: Paxos Checkup Study Mobile Medical Application
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.
Other Name: Checkup Study




Primary Outcome Measures :
  1. Near Corrected Visual Acuity [ Time Frame: Eight weeks ]
    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.

  2. Amsler Grid [ Time Frame: Eight weeks ]
    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


Secondary Outcome Measures :
  1. Feasibility of home testing using Paxos Checkup Mobile application [ Time Frame: Eight weeks ]
    Assessment of study subjects ability to successfully complete a home test using the Feasibility of home testing measured by Paxos Checkup Mobile application.

  2. Assess repeatability of mobile application testing [ Time Frame: 8 weeks ]
    Assess the repeatability of in-office Checkup visual acuity and Amsler testing.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population includes patients with no pathology, patients with Diabetic Retinopathy and patients with Adult Macular Degeneration.
Criteria

Inclusion Criteria:

  • 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.

Specific Inclusion Criteria for Subgroup with Normal Eyes

  • Best Corrected Near Visual acuity 20/32 or better in each eye
  • No concurrent systemic illness affecting the retina and vision.

Specific Inclusion Criteria for Subgroups with AMD or DR

  • Diagnosis of either AMD or DR (all subgroups qualify)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871817


Locations
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United States, Arizona
Phoenix, Arizona, United States
United States, California
Mountain View, California, United States
United States, Florida
Fort Myers, Florida, United States
Miami, Florida, United States
Tallahassee, Florida, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Nevada
Reno, Nevada, United States
United States, Ohio
Cleveland, Ohio, United States, 44122
United States, Tennessee
Nashville, Tennessee, United States, 37215
United States, Texas
Austin, Texas, United States
San Antonio, Texas, United States
United States, Washington
Spokane, Washington, United States
Sponsors and Collaborators
Digisight Technologies, Inc.
Investigators
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Study Director: Carol Hoang Digisight Technologies, Inc.

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Responsible Party: Digisight Technologies, Inc.
ClinicalTrials.gov Identifier: NCT02871817     History of Changes
Other Study ID Numbers: SPD02000-01
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Digisight Technologies, Inc.:
Near Corrected Visual Acuity
Early Treatment Diabetes Retinopathy Study
Amsler Grid
Home Monitoring

Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Diabetic Retinopathy
Vision Disorders
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms