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Trial record 87 of 81593 for:    measured

Repeatability and Concordance of VA Measured With ETDRS Numeric , Landolt C, and Letter Charts in Thai Individuals

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ClinicalTrials.gov Identifier: NCT02810665
Recruitment Status : Unknown
Verified June 2016 by Voraporn Chaikitmongkol, Chiang Mai University.
Recruitment status was:  Recruiting
First Posted : June 23, 2016
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
Voraporn Chaikitmongkol, Chiang Mai University

Brief Summary:
This is a cross-sectional study to determine the repeatability and concordance of visual acuity level measured with the original ETDRS letter, ETDRS Landolt C, and ETDRS numeric chart in Thai individuals.

Condition or disease Intervention/treatment
Visual Nonspecific Behavioral: Visual acuity measurement by ETDRS chart

Detailed Description:

The ETDRS visual acuity chart has been used as a standard visual acuity measurement chart in ophthalmic clinical trials due to its proven high repeatability comparing to other visual acuity chart. However, the original ETDRS alphabet chart could not be used in every individual around the world, especially those who are non-english speakers. Landolt C chart has been a recommended chart to test visual acuity in those living in a country where English is not a common language, however, some difficulties including right-left confusion occurred when testing with the Landolt C chart, leading to the unreliable results of visual acuity measurement using the Landolt C chart. Recently, the ETDRS numeric chart was introduced by some medical equipment companies but there is limited information regarding the repeatability and concordance of the new ETDRS numeric chart comparing to the original ETDRS alphabet and Landolt C chart.

Therefore, this study aims to determine the repeatability and concordance of visual acuity level measured with the original ETDRS alphabet, the ETDRS Landolt C, and the ETDRS numeric chart. Results from this study would be able to suggest an appropriate ETDRS chart to be used in clinical studies in Thailand or other countries where English is not the native language.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 180 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Repeatability and Concordance of Visual Acuity Level Measured With ETDRS Numeric Charts, ETDRS Landolt C Charts, and Original ETDRS Letter Visual Acuity Charts in Thai Individuals
Study Start Date : July 2015
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

Group/Cohort Intervention/treatment
Normal vision group
Individuals with VA 20/20 to 20/25
Behavioral: Visual acuity measurement by ETDRS chart
All participants must complete VA measurement of the study eye using 3 charts including the original ETDRS alphabet, ETDRS Landolt C, and ETDRS numeric charts for 2 times, at least 30 minutes apart.

Impaired vision group
Individuals with impaired vision: VA of 20/32 to 20/200 due to either cataract, diabetic macular edema, or age-related macular degeneration
Behavioral: Visual acuity measurement by ETDRS chart
All participants must complete VA measurement of the study eye using 3 charts including the original ETDRS alphabet, ETDRS Landolt C, and ETDRS numeric charts for 2 times, at least 30 minutes apart.




Primary Outcome Measures :
  1. Concordance of VA tested with ETDRS alphabet, Landolt C and numeric visual acuity charts [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Repeatability of VA tested with ETDRS alphabet, Landolt C and numeric visual acuity charts [ Time Frame: Day 1 ]
  2. Differences in testing duration of VA measurement across the 3 ETDRS charts [ Time Frame: Day 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants with normal vision (VA of 20/20 to 20/25) and decreased vision (VA of 20/32 to 20/200 due to cataract, diabetic macular edema, or age-related macular degeneration) who gave consent to participate in this study
Criteria

Inclusion Criteria:

  • Thai nationality
  • More than 18 years of age
  • Educational level: at least high school
  • Able to read English alphabet

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): NCT02810665


Contacts
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Contact: Voraporn Chaikitmongkol, MD 66-53-93-5512 vchaikitmongkol@gmail.com
Contact: Onnisa Nanegrungsunk, MD 66-53-93-5512 tiennaneg@gmail.com

Locations
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Thailand
Voraporn Chaikitmongkol Recruiting
Muang Chiang Mai, Chiang Mai, Thailand, 50200
Contact: Voraporn Chaikitmongkol, MD    66-53-935512    vchaikitmongkol@gmail.com   
Contact: Onnisa Nanegrungsunk, MD       tiennaneg@gmail.com   
Sponsors and Collaborators
Chiang Mai University

Additional Information:

Publications of Results:
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Responsible Party: Voraporn Chaikitmongkol, Instructor, Chiang Mai University
ClinicalTrials.gov Identifier: NCT02810665     History of Changes
Other Study ID Numbers: OPT-2558-03133
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Voraporn Chaikitmongkol, Chiang Mai University:
Repeatability
Concordance
Agreement
ETDRS visual acuity chart
numeric
Landolt C
Roman alphabet