MyopiaNCT03456245
Comparing Low-cost Handheld Autorefractors - a Practical Approach to Measuring Refraction in Low Resource Settings
An observational study of Myopia and Hyperopia, run by Harvard School of Public Health (HSPH).
Trial summary
Study compares four portable vision measurement and eye-imaging technologies in terms of accuracy and time and ease of use with older adult (ages 40-100) participants in a developing-country setting (India). Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- What is being tested?
- Vision device validation
- Type of treatment
- Medical device
- How many people
- 205 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2016to 1 Sep 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals aged 40-100 coming to Sankara Eye Hospital for standard eyesight evaluation from surrounding urban/rural communities
Who may be able to join
- Individuals aged 40-100 coming to Sankara Eye Hospital from surrounding urban/rural communities.
Who cannot join
- Individuals under the age of 40.
- Blind individuals
- Individuals with acute glaucoma, eye trauma/injury, infections such as conjunctivitis
- Individuals physically/cognitively incapable of following basic instructions and sitting/standing still in order to use devices.
About this study
Official title: A Validation Study of Mobile Technologies for Assessing Visual Acuity and Eye Health Among Older Adults in India
Study compares four portable vision measurement and eye-imaging technologies in terms of accuracy and time and ease of use with older adult (ages 40-100) participants in a developing-country setting (India). Specifically, the five portable devices will be measured against the baseline of the traditional eye-examination techniques, including the use of eye charts and phoropters.
Read the detailed description
Non-communicable diseases (NCDs) are a large and increasingly costly problem for India. Recent research estimates that NCDs could cost the Indian economy US$6.2 trillion from 2012-2030 if left unaddressed. For some NCDs, new solutions will need to be developed for diagnosis and treatment, while, for others, the necessary interventions exist but are not readily available to all who need them. Visual impairment is one area of health in which limited access to diagnostic and treatment technologies jeopardizes the health and economic well-being of the population. This is particularly true in India, where the population is rapidly aging and, despite the presence of some high-quality medical facilities, there remains a large burden of unaddressed visual impairment.
Loss of visual acuity can negatively impact individual and household income by reducing productivity or hours worked among the visually impaired; it can also affect economic wellbeing via the need for caretakers. There are two key tests that determine visual acuity and measure vision loss:
- Basic visual acuity (BVA), which is assessed using the naked eye or, when applicable, eyeglasses, and
- Best-corrected visual acuity (BCVA), which uses refraction to determine eyeglass/contact lens prescription.
In addition, diagnosing vision-hindering eye conditions requires specific medications or surgical procedures. Diagnosis of glaucoma, cataracts, or diabetic retinopathy typically requires a physician to examine a patient's retinas, corneas, and/or pupils at close range using specialized equipment, in conjunction with the visual acuity tests described above.
BCVA tests typically require heavy, cumbersome, and expensive equipment such as phoropters (instruments that measure the refractive state of the eye). Likewise, eye diseases typically require the use of specialized equipment such as slit lamp microscopes, ophthalmoscopes, and tonometers.
However, the recent and anticipated availability of affordable and lightweight portable technologies which can be used both by medical professionals and by trained laypeople has made eye testing easier and faster. This study will validate a number of new handheld devices developed for visual acuity measurement and retinal imaging.
This study explores testing for visual acuity and other impairments like diabetic retinopathy, glaucoma, age-related macular degeneration (AMD), and cataract without the use of traditional stationery and expensive instruments such as phoropters and conventional autorefractors and at a comparatively low cost. If the devices are proven able to accurately evaluate visual acuity and produce high-quality retinal images that can be used to aid diagnosis, it will be a breakthrough in reducing barriers of access to eye care facilities encountered by the majority of the rural population in India and other developing countries.
Also, since these devices are convenient and relatively easy to use, they can be easily used in household/community surveys involving vision measurement; the investigators are proposing to perform data collection for this study in India partially in order to investigate the potential for use of one or more of handheld devices in upcoming waves of the Longitudinal Aging Study in India (Protocol Number 16715), a nationally-representative aging and retirement study that collects data on multiple dimensions of aging, including socioeconomic, cognitive, and health indicators with the aim of informing national policy and practice relating to older adults. Specifically, the study involves an extensive biomarkers module which includes direct measurement of multiple medical and anthropometric indicators, such as blood pressure, grip strength, lung function, height, and weight. The current version of the biomarkers module calls for the use of a traditional eye chart to measure BVA; however, future versions of the study would greatly benefit from the use, if feasible, of portable and inexpensive devices which would allow researchers to collect richer and more accurate data on visual acuity and/or eye conditions and therefore provide a more detailed picture on older adults' eye health, as well as the predictors and correlates of eye health, on a national level.
Through the data gained from this study, the investigators hope to be able to develop useful recommendations for researchers, community health organizations, and health care professionals whose studies and patients would benefit from access to relatively low-cost portable vision measurement and retinal imaging devices. In particular, Indian consumers will have access to all devices pending market approval.
- Being tested
- Vision device validation
- Medical subject headings
- Myopia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vision device validationDevice
Group members had their vision tested with the following devices/methods: Eyenetra NETRA, PlenOptika Quicksee, Right Manufacturing Retinomax K Plus 3, and standard eyesight tests using eye charts, phoropters, and slit lens lamp imaging.
| Study group | Role | What they receive |
|---|---|---|
| Vision device validation | In the single arm of this study, all members of this group were examined using a number of mobile eyesight assessment devices. Receives: Device: Vision device validation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Assessment of Participants' Best Visual Acuity (in Diopters)
Measurements of participants' best visual acuity as measured by mobile devices compared to "gold standard" of subjective refraction
Measured: 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start15 Aug 2016
- Primary completion1 Sep 2016
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MyopiaStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Sankara Eye Hospital
- Responsible party
- Principal investigator, David Bloom, Harvard School of Public Health (HSPH)
- Investigators
- David E Bloom, PhD, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456245
- Sponsor's protocol ID
- 22636
- Status last verified
- Feb 2020
- First submitted
- 20 Jul 2017
- Last updated
- 24 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation Study of Mobile Technologies for Assessing Visual Acuity and Eye Health Among Older Adults in India
- ClinicalTrials.gov ID
- NCT03456245
- Acronym / sponsor ID
- 22636
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Sankara Eye Hospital
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 7 Mar 2018 (actual)
- Results
- Posted 24 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study compares four portable vision measurement and eye-imaging technologies in terms of accuracy and time and ease of use with older adult (ages 40-100) participants in a developing-country setting (India). Specifically, the five portable devices will be measured against the baseline of the traditional eye-examination techniques, including the use of eye charts and phoropters.
Detailed description
Non-communicable diseases (NCDs) are a large and increasingly costly problem for India. Recent research estimates that NCDs could cost the Indian economy US$6.2 trillion from 2012-2030 if left unaddressed. For some NCDs, new solutions will need to be developed for diagnosis and treatment, while, for others, the necessary interventions exist but are not readily available to all who need them. Visual impairment is one area of health in which limited access to diagnostic and treatment technologies jeopardizes the health and economic well-being of the population. This is particularly true in India, where the population is rapidly aging and, despite the presence of some high-quality medical facilities, there remains a large burden of unaddressed visual impairment.
Loss of visual acuity can negatively impact individual and household income by reducing productivity or hours worked among the visually impaired; it can also affect economic wellbeing via the need for caretakers. There are two key tests that determine visual acuity and measure vision loss:
- Basic visual acuity (BVA), which is assessed using the naked eye or, when applicable, eyeglasses, and
- Best-corrected visual acuity (BCVA), which uses refraction to determine eyeglass/contact lens prescription.
In addition, diagnosing vision-hindering eye conditions requires specific medications or surgical procedures. Diagnosis of glaucoma, cataracts, or diabetic retinopathy typically requires a physician to examine a patient's retinas, corneas, and/or pupils at close range using specialized equipment, in conjunction with the visual acuity tests described above.
BCVA tests typically require heavy, cumbersome, and expensive equipment such as phoropters (instruments that measure the refractive state of the eye). Likewise, eye diseases typically require the use of specialized equipment such as slit lamp microscopes, ophthalmoscopes, and tonometers.
However, the recent and anticipated availability of affordable and lightweight portable technologies which can be used both by medical professionals and by trained laypeople has made eye testing easier and faster. This study will validate a number of new handheld devices developed for visual acuity measurement and retinal imaging.
This study explores testing for visual acuity and other impairments like diabetic retinopathy, glaucoma, age-related macular degeneration (AMD), and cataract without the use of traditional stationery and expensive instruments such as phoropters and conventional autorefractors and at a comparatively low cost. If the devices are proven able to accurately evaluate visual acuity and produce high-quality retinal images that can be used to aid diagnosis, it will be a breakthrough in reducing barriers of access to eye care facilities encountered by the majority of the rural population in India and other developing countries.
Also, since these devices are convenient and relatively easy to use, they can be easily used in household/community surveys involving vision measurement; the investigators are proposing to perform data collection for this study in India partially in order to investigate the potential for use of one or more of handheld devices in upcoming waves of the Longitudinal Aging Study in India (Protocol Number 16715), a nationally-representative aging and retirement study that collects data on multiple dimensions of aging, including socioeconomic, cognitive, and health indicators with the aim of informing national policy and practice relating to older adults. Specifically, the study involves an extensive biomarkers module which includes direct measurement of multiple medical and anthropometric indicators, such as blood pressure, grip strength, lung function, height, and weight. The current version of the biomarkers module calls for the use of a traditional eye chart to measure BVA; however, future versions of the study would greatly benefit from the use, if feasible, of portable and inexpensive devices which would allow researchers to collect richer and more accurate data on visual acuity and/or eye conditions and therefore provide a more detailed picture on older adults' eye health, as well as the predictors and correlates of eye health, on a national level.
Through the data gained from this study, the investigators hope to be able to develop useful recommendations for researchers, community health organizations, and health care professionals whose studies and patients would benefit from access to relatively low-cost portable vision measurement and retinal imaging devices. In particular, Indian consumers will have access to all devices pending market approval.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vision device validation | – | Device: Vision device validationIn the single arm of this study, all members of this group were examined using a number of mobile eyesight assessment devices. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals aged 40-100 coming to Sankara Eye Hospital for standard eyesight evaluation from surrounding urban/rural communities
Key inclusion criteria (1 listed)
- Individuals aged 40-100 coming to Sankara Eye Hospital from surrounding urban/rural communities.
Key exclusion criteria (4 listed)
- Individuals under the age of 40.
- Blind individuals
- Individuals with acute glaucoma, eye trauma/injury, infections such as conjunctivitis
- Individuals physically/cognitively incapable of following basic instructions and sitting/standing still in order to use devices.
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 |
|---|---|---|
| Vision device validationGroup members had their vision tested with the following devices/methods: Eyenetra NETRA, PlenOptika Quicksee, Right Manufacturing Retinomax K Plus 3, and standard eyesight tests using eye charts, phoropters, and slit lens lamp imaging. | Device | Vision device validation |
Primary outcome
Accuracy of Assessment of Participants' Best Visual Acuity (in Diopters)
Time frame: 1-2 hours
Measurements of participants' best visual acuity as measured by mobile devices compared to "gold standard" of subjective refraction
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
David E Bloom, PhD principal investigator
Harvard School of Public Health (HSPH)
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia and Hyperopia, run by Harvard School of Public Health (HSPH).
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 4 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 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 24 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Accuracy of Assessment of Participants' Best Visual Acuity (in Diopters) (time frame: 1-2 hours). 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 24 Feb 2020.