Comparing Low-cost Handheld Autorefractors - a Practical Approach to Measuring Refraction in Low Resource Settings

• Sponsor: Harvard School of Public Health (HSPH) (Other)
• Overall Status: Completed
• CT.gov ID: NCT03456245
• Collaborator: Sankara Eye Hospital (Other)
• Enrollment: 205
• Actual Duration (Days): 17

Study Details

Study Description

Brief 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). 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.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Hyperopia	Device: Vision device validation

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:

1. Basic visual acuity (BVA), which is assessed using the naked eye or, when applicable, eyeglasses, and

2. 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

• Study Type: Observational
• Actual Enrollment: 205 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: A Validation Study of Mobile Technologies for Assessing Visual Acuity and Eye Health Among Older Adults in India
• Actual Study Start Date: Aug 15, 2016
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: Vision device validation; 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.

Outcome Measures

Primary Outcome Measures

1. Accuracy of Assessment of Participants' Best Visual Acuity (in Diopters) [1-2 hours]

   Measurements of participants' best visual acuity as measured by mobile devices compared to "gold standard" of subjective refraction

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Individuals aged 40-100 coming to Sankara Eye Hospital from surrounding urban/rural communities.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Harvard School of Public Health (HSPH)
• Sankara Eye Hospital

Investigators

• Principal Investigator: David E Bloom, PhD, Harvard School of Public Health (HSPH)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Bloom, Professor, Harvard School of Public Health (HSPH)
• ClinicalTrials.gov Identifier: NCT03456245
• Other Study ID Numbers: 22636
• First Posted: Mar 7, 2018
• Last Update Posted: Feb 24, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Hyperopia

Study Results

Participant Flow

Arm/Group Title	Vision Device Validation
Arm/Group Description	In the single arm of this study, all members of this group were examined using a number of mobile eyesight assessment devices. Vision device validation: Group members had their vision tested with the following devices/methods: D-EYE Portable Retinal Imaging System, Eyenetra NETRA, PlenOptika Quicksee, Right Manufacturing Retinomax K Plus 3, and standard eyesight tests using eye charts, phoropters, and slit lens lamp imaging.
Period Title: Overall Study
STARTED	205
COMPLETED	190
NOT COMPLETED	15

Baseline Characteristics

Arm/Group Title	Vision Device Validation
Arm/Group Description	In the single arm of this study, all members of this group were examined using a number of mobile eyesight assessment devices. Vision device validation: Group members had their vision tested with the following devices/methods: D-EYE Portable Retinal Imaging System, Eyenetra NETRA, PlenOptika Quicksee, Right Manufacturing Retinomax K Plus 3, and standard eyesight tests using eye charts, phoropters, and slit lens lamp imaging.
Overall Participants	190
Overall Eyes	374
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	52.44
Sex: Female, Male (Count of Participants)
Female	91 47.9%
Male	99 52.1%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
India	190 100%

Outcome Measures

1. Primary Outcome

Title	Accuracy of Assessment of Participants' Best Visual Acuity (in Diopters)
Description	Measurements of participants' best visual acuity as measured by mobile devices compared to "gold standard" of subjective refraction
Time Frame	1-2 hours

Outcome Measure Data

Analysis Population Description

No difference in the analysis population

Arm/Group Title	Vision Device Validation
Arm/Group Description	In the single arm of this study, all members of this group were examined using a number of mobile eyesight assessment devices. Vision device validation: Group members had their vision tested with the following devices/methods: D-EYE Portable Retinal Imaging System, Eyenetra NETRA, PlenOptika Quicksee, Right Manufacturing Retinomax K Plus 3, and standard eyesight tests using eye charts, phoropters, and slit lens lamp imaging.
Measure Participants	190
Difference btw Subjective refraction and Retinomax	0.685
Difference btw Subjective refraction and EyeNetra	-0.416
Difference btw Subjective refraction and Quicksee	-0.039

Adverse Events

Adverse Event Reporting Description	All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
Arm/Group Title	Vision Device Validation
Arm/Group Description
All Cause Mortality
	Vision Device Validation
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Vision Device Validation
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Vision Device Validation
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.