Diabetic Retinopathy Clinical Trial
— CLEAROfficial title:
The Correlation of the Checkup Vision Assessment System to Standard In Office Visual Assessment
Verified date | January 2018 |
Source | Digisight Technologies, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 143 |
Est. completion date | March 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Digisight Technologies, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Feasibility of home testing using Paxos Checkup Mobile application | Assessment of study subjects ability to successfully complete a home test using the Feasibility of home testing measured by Paxos Checkup Mobile application. | Eight weeks | |
Secondary | Assess repeatability of mobile application testing | Assess the repeatability of in-office Checkup visual acuity and Amsler testing. | 8 weeks |
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