Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04520243
Status:
COMPLETED
Last Update Posted:
2020-08-20
First Post:
2020-08-17
Brief Title:
Evaluation of Letters Versus Numbers ELEVEN Study
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Evaluation of Letters Versus Numbers ELEVEN Study ETDRS Visual Acuity Chart Performance in an English Alphabet Illiterate Population
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELEVEN
Brief Summary:
This is a prospective randomised controlled trial to determine the performance of Best Corrected Visual Acuity BCVA scores using the ETDRS number chart were compared with ETDRS alphabet chart in healthy eyes of patients who do not recognise the English alphabet
Detailed Description:
BACKGROUND The measurement of visual acuity is important in the clinical setting to assess visual function and treatment response while in research to provide objective clinical outcomes The current gold standard for visual acuity measurement in most research studies including major clinical trials is the Early Treatment Diabetic Retinopathy Study ETDRS chart designed by Bailey and Lovie However this may not be suitable for participants who are illiterate Alternatives exist including the ETDRS numbers chart Landolt C chart and Tumbling E chart Existing studies show that the Landolt C and Tumbling E charts are alternatives with agreement with ETDRS letters chart in healthy and diseased eyes However the charts are limited by their 25 if four orientations or 125 if eight orientations chance of guessing the orientation of the letter
The ETDRS numbers chart may overcome this limitation as it uses five unique numbers instead of a single rotating letter There are few studies evaluating the different types of visual acuity measurement among those unfamiliar with the English alphabet Though one study shows high repeatability and agreement between the ETDRS letters and numbers charts in healthy and diseased eyes of English literate individuals and shorter testing duration when using the numbers chart this finding has not been validated in individuals unfamiliar with the English alphabet This study aims to evaluate how the ETDRS letters and numbers charts compare in individuals unfamiliar with the English alphabet
METHODS Eligible subjects were divided into 2 groups according to level of literacy Literacy was determined by self-reported exposure to the English alphabet and recognition of the 10 Sloan letters C D H K N O R S V and Z Subjects included were classified into the 2 groups group A with no exposure to the English alphabet and recognition of 610 letters and group B with exposure to the English alphabet and recognition of 610 letters
Testing Each subject underwent 2 rounds of BCVA measurements using 2 types of ETDRS charts in randomized sequence as follows LN or NL L ETDRS letters chart N ETDRS numbers chart from Precision Vision PV The randomization of the testing sequence was performed by a study coordinator independent of study recruiter optometrist or investigator Sequentially numbered opaque and sealed envelopes were used for allocation concealment and opened by the optometrist prior to testing
The tests were performed and recorded by a single optometrist in the same testing room with similar lighting conditions For every round of testing the right eye was examined first followed by the left eye For the right eye numbers chart PV No 2702A and letters chart PV No 2173 were used For the left eye the numbers chart PV No 2714A and letters chart PV No 2174 were used Different charts with the same optotypes but in different order were used for right and left eyes to minimize the effect of learning between consecutive tests
The ETDRS numbers chart may overcome this limitation as it uses five unique numbers instead of a single rotating letter There are few studies evaluating the different types of visual acuity measurement among those unfamiliar with the English alphabet Though one study shows high repeatability and agreement between the ETDRS letters and numbers charts in healthy and diseased eyes of English literate individuals and shorter testing duration when using the numbers chart this finding has not been validated in individuals unfamiliar with the English alphabet This study aims to evaluate how the ETDRS letters and numbers charts compare in individuals unfamiliar with the English alphabet
METHODS Eligible subjects were divided into 2 groups according to level of literacy Literacy was determined by self-reported exposure to the English alphabet and recognition of the 10 Sloan letters C D H K N O R S V and Z Subjects included were classified into the 2 groups group A with no exposure to the English alphabet and recognition of 610 letters and group B with exposure to the English alphabet and recognition of 610 letters
Testing Each subject underwent 2 rounds of BCVA measurements using 2 types of ETDRS charts in randomized sequence as follows LN or NL L ETDRS letters chart N ETDRS numbers chart from Precision Vision PV The randomization of the testing sequence was performed by a study coordinator independent of study recruiter optometrist or investigator Sequentially numbered opaque and sealed envelopes were used for allocation concealment and opened by the optometrist prior to testing
The tests were performed and recorded by a single optometrist in the same testing room with similar lighting conditions For every round of testing the right eye was examined first followed by the left eye For the right eye numbers chart PV No 2702A and letters chart PV No 2173 were used For the left eye the numbers chart PV No 2714A and letters chart PV No 2174 were used Different charts with the same optotypes but in different order were used for right and left eyes to minimize the effect of learning between consecutive tests
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None