Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03456245
Recruitment Status : Completed
First Posted : March 7, 2018
Results First Posted : February 24, 2020
Last Update Posted : February 24, 2020
Sponsor:
Collaborator:
Sankara Eye Hospital
Information provided by (Responsible Party):
David Bloom, Harvard School of Public Health

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
Myopia Hyperopia Device: Vision device validation

Show Show detailed description

Layout table for study information
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 : August 15, 2016
Actual Primary Completion Date : September 1, 2016
Actual Study Completion Date : September 1, 2016

Resource links provided by the National Library of Medicine


Group/Cohort 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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456245


Sponsors and Collaborators
Harvard School of Public Health
Sankara Eye Hospital
Investigators
Layout table for investigator information
Principal Investigator: David E Bloom, PhD Harvard School of Public Health

Layout table for additonal information
Responsible Party: David Bloom, Professor, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT03456245    
Other Study ID Numbers: 22636
First Posted: March 7, 2018    Key Record Dates
Results First Posted: February 24, 2020
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Hyperopia
Refractive Errors
Eye Diseases