- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04391166
Validity of at Home Visual Acuity Measurements for Telemedicine During Corona Virus (COVID-19) Pandemic
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Project Title Validity of Home Visual Acuity Measurements with an ETDRS Chart
Project Summary Prompted by the current COVID-19 pandemic, the American Academy of Ophthalmology has recommended the use of telemedicine to continue ophthalmic care while maintaining patient and provider social distancing. As part of remote examinations, patients may be expected to perform home eye testing for visual acuity and the use of various home visual acuity charts have been proposed to provide clinicians with this vital data. However, the use of home visual acuity exams has not been validated in our patient population. This project aims to determine the efficacy and validity of measuring visual acuity at home with a printed-out ETDRS chart.
Project Description Rationale: Many ophthalmology visits are being conducted remotely via telehealth. The use of home ETDRS charts is being proposed for patients to report their visual acuity. However, the efficacy and validity of this method in our population should be determined.
Objective: Determine the efficacy and validity of measuring visual acuity at home with a printed-out ETDRS chart in the population served by Vanderbilt Eye Institute. Our hypothesis is that measuring visual acuity at home with a printed-out ETDRS is non-inferior to visual acuity measurements by a trained technician in the clinic.
Methodology: The study population will include patients scheduled for in-person visits for various subspecialties (Glaucoma, Retina/Uveitis, Pediatrics and Cornea) at Vanderbilt Eye Institute's (VEI) Nashville campus during the period of 4/27/20-5/27/20. Patients will be excluded if they have a last best corrected visual acuity worse than 20/200, have not activated a My Health at Vanderbilt (MHAV) account, or do not speak English. Patients will also need to be between the ages of 18-90 to Approximately one week prior to their appointments, patients will be called to obtain e-consent and provide detailed instructions for measuring best corrected visual acuity at home with the ETDRS chart that is calibrated for 5 feet. Instructions will also be sent via MHAV along with the ETDRS chart and the consent form. Data collected will include age, sex, and primary ophthalmological diagnosis as well as last measured Snellen visual acuity (+/-3months). The department, provider, and date of the in-person appointment will also be collected. Patients will be instructed to complete a home visual acuity check two-four days prior to appointment and send a message through MHAV with the results. Participants will record the smallest full line ( 5 letters) in each eye that they can read. If a message is not received two days prior to the appointment, a research assistant will call the patient back to reconfirm the plan. At the in-person visit, patients will begin their encounter with an ETDRS assessment at VEI, using the ETDRS chart at 20 feet. Again, the full line of 5 letters read will be used for analysis. Patients will receive a survey to be completed in clinic with a 5-point Likert scale to rate the ease of home visual acuity as well as a short response question about barriers to assessment.
Data Management and Analysis: Data will be collected from the electronic health record (EHR) and kept in a password-protected deidentified Excel document. Visual acuities will be converted to logMAR for analysis.
Ethical Considerations: There are no ethical considerations to report.
Barriers to Home Visual acuity testing
- Poor/no access to the technical requirements - computer, printer, internet
- Do not feel confident of being able to test vision accurately at home
- Attempted to test vision at home but was unable to follow instructions completely
- Do not want to try it at home, medical procedures should be done in a clinic
- Vision too poor to perform these tasks
The Home visual acuity test was easy to set up and perform
- Strongly disagree
- Disagree
- Neither agree nor disagree
- Agree
- Strongly agree
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt Eye Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The study population will include patients scheduled for in-person visits for various subspecialties (Glaucoma, Retina/Uveitis, pediatrics and Cornea) at Vanderbilt Eye Institute's (VEI) Nashville campus during the period of 4/27/20-5/8/20.
Between the ages of 18-90.
Description
Inclusion Criteria:
- The study population will include patients scheduled for in-person visits for various subspecialties (Glaucoma, Retina/Uveitis, pediatrics and Cornea) at Vanderbilt Eye Institute's (VEI) Nashville campus during the period of 4/27/20-5/8/20.
Exclusion Criteria:
- Patients will be excluded if they have a last best corrected visual acuity worse than 20/200.
- If they have not activated a My Health at Vanderbilt (MHAV) account
- If they do not speak English.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best Corrected Visual Acuity (BCVA) Per Eye
Time Frame: From the time they sign the consent until we take their BCVA in clinic. Approximately 1-2 weeks.
|
Best Visual Acuity per eye
|
From the time they sign the consent until we take their BCVA in clinic. Approximately 1-2 weeks.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200826
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Visual Impairment
-
Universitaire Ziekenhuizen KU LeuvenKU Leuven; University Ghent; Research Foundation Flanders; Free University of Brussels and other collaboratorsUnknowniVision - Development of a Game-based Therapy for Children With Cerebral Visual Impairment (iVision)Visual Perceptual Weakness (Disorder) | Cerebral Visual ImpairmentBelgium
-
Novartis PharmaceuticalsCompletedNeovascular AMD, Visual Impairment Due to DME, Visual Impairment Due to Macular Oedema Secondary to Branch or Central RVO, Visual Impairment Due to CNVGermany
-
Universitaire Ziekenhuizen KU LeuvenVrije Universiteit Brussel; Fund for Scientific Research, Flanders, BelgiumRecruitingCerebral Visual ImpairmentBelgium
-
Russell L. WoodsResearch to Prevent Blindness / Lions Club International FoundationNot yet recruitingCentral Visual Impairment
-
Children's Hospital Medical Center, CincinnatiCompleted
-
Clinique Rive GaucheCompletedVisual Impairment in ChildrenFrance
-
Nantes University HospitalTerminatedCentral or Peripheral Visual ImpairmentFrance
-
VA Office of Research and DevelopmentCompletedScotoma, Central | Central Visual ImpairmentUnited States
-
University Health Network, TorontoNot yet recruitingStroke | Cognitive Impairment | Virtual Reality | Visual Impairment | Low Vision | Driving Impaired | Visual Spatial Processing | Visual Processing Speed | Visual Field DefectCanada
Clinical Trials on Non invasive visual acuity testing
-
Vienna Institute for Research in Ocular SurgeryCompletedEpiretinal MembraneAustria
-
Shahid Beheshti University of Medical SciencesUnknownInherited Retinal Dystrophy Primarily Involving Sensory Retina | Inherited Retinal Dystrophy Primarily Involving Retinal Pigment EpitheliumIran, Islamic Republic of
-
Democritus University of ThraceUnknownMacular Edema | Refractive Errors | Low VisionGreece
-
University of BaselCompletedVisual AcuitySwitzerland
-
Assistance Publique - Hôpitaux de ParisCompleted
-
TheradexUnknownPancreatic CancerUnited States
-
University of MichiganNational Eye Institute (NEI)Recruiting
-
Fondation Ophtalmologique Adolphe de RothschildRecruiting
-
University of Texas Southwestern Medical CenterWithdrawnAtrial FibrillationUnited States
-
Moorfields Eye Hospital NHS Foundation TrustKing's College London; Cardiff University; University College, London; Newcastle... and other collaboratorsRecruiting