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

NCT03456245 | Completed Results FDA Device

• 1 other identifier: 22636
• Study Type: observational
• Target: 205
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myopia; Hyperopia

Outcome Measures

Primary Outcomes (1)

• 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

  1-2 hours

Study Arms (1)

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

Interventions

Vision device validation DEVICE

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.

Vision device validation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals aged 40-100 coming to Sankara Eye Hospital for standard eyesight evaluation from surrounding urban/rural communities

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Myopia; Hyperopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Dr. David Bloom
• Organization: Harvard TH Chan School of Public Health

dbloom@hsph.harvard.edu

6174320650

Study Officials

• David E Bloom, PhD

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: March 7, 2018
• Study Start: August 15, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 24, 2020
• Results First Posted: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share