Visual ImpairmentNCT04391166
Validity of at Home Visual Acuity Measurements for Telemedicine During Corona Virus (COVID-19) Pandemic
An observational study of Visual Impairment, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Impairment
- What is being tested?
- Non invasive visual acuity testing
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2020to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Eye Institute
Nashville, Tennessee, 37232
About this study
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.
Read the 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
- Conditions
- Visual Impairment
- Being tested
- Non invasive visual acuity testing
- Keywords
- ETDRS Visual acuity
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive visual acuity testingOther
This will be visual acuity at home and visual acuity in clinic both using an ETDRS chart.
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity (BCVA) Per Eye
Best Visual Acuity per eye
Measured: From the time they sign the consent until we take their BCVA in clinic. Approximately 1-2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start20 May 2020
- Primary completion10 Jul 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual ImpairmentStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sapna Gangaputra, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391166
- Sponsor's protocol ID
- 200826
- Status last verified
- Mar 2021
- First submitted
- 15 May 2020
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of at Home Visual Acuity Measurements for Telemedicine During Corona Virus (COVID-19) Pandemic
- ClinicalTrials.gov ID
- NCT04391166
- Acronym / sponsor ID
- 200826
- Conditions
- Visual Impairment
- Keywords
- ETDRS Visual acuity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 10 Jul 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non invasive visual acuity testingThis will be visual acuity at home and visual acuity in clinic both using an ETDRS chart. | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Impairment, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.