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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

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Cross-Sectional
Conditions Myopia
Hyperopia
Intervention Device: Vision device validation
Enrollment 205
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vision Device Validation
Hide 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
Arm/Group Title Vision Device Validation
Hide 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 Number of Baseline Participants 190
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
374
Hide Baseline Analysis Population Description
No difference in the population numbers.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 190 participants
52.44
(40 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants
Female
91
  47.9%
Male
99
  52.1%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
India Number Analyzed 190 participants
190
1.Primary Outcome
Title Accuracy of Assessment of Participants' Best Visual Acuity (in Diopters)
Hide Description Measurements of participants' best visual acuity as measured by mobile devices compared to "gold standard" of subjective refraction
Time Frame 1-2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
No difference in the analysis population
Arm/Group Title Vision Device Validation
Hide 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 Number of Participants Analyzed 190
Mean (95% Confidence Interval)
Unit of Measure: Diopters
Difference btw Subjective refraction and Retinomax
0.685
(.489 to .881)
Difference btw Subjective refraction and EyeNetra
-0.416
(-0.675 to -0.157)
Difference btw Subjective refraction and Quicksee
-0.039
(-0.250 to 0.171)
Time Frame [Not Specified]
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
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Vision Device Validation
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Vision Device Validation
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vision Device Validation
Affected / at Risk (%)
Total   0/0 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. David Bloom
Organization: Harvard TH Chan School of Public Health
Phone: 6174320650
EMail: dbloom@hsph.harvard.edu
Layout table for additonal information
Responsible Party: David Bloom, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT03456245    
Other Study ID Numbers: 22636
First Submitted: July 20, 2017
First Posted: March 7, 2018
Results First Submitted: October 15, 2019
Results First Posted: February 24, 2020
Last Update Posted: February 24, 2020