Evaluation of Letters Versus Numbers (ELEVEN) Study

NCT04520243 | Completed

• 1 other identifier: ELEVEN
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Visual Acuity

Keywords

ETDRS visual acuity; English alphabet illiterate; ETDRS number chart

Outcome Measures

Primary Outcomes (2)

• BCVA Measurements

  Assessment of BCVA using ETDRS numbers and letters chart and its comparison between the testing groups and intervention methods. All visual acuity tests were performed at 3 metres with at least 15 seconds between each chart. Subjects were asked to read as many optotypes as possible according to the ICO Visual Acuity Measurement Standard.

  1 day

• Testing Duration

  Assessment of testing duration using ETDRS numbers and letters and its comparison between the testing groups and intervention methods. The testing durations of each visual acuity test were measured and recorded by a single timekeeper with a standard digital chronometer.

  1 day

Study Arms (2)

English alphabet illiterate group

EXPERIMENTAL

Individuals with no self-reported understanding of English alphabet and recognition of \<6/10 Sloan Letters

Diagnostic Test: Visual acuity assessment by ETDRS charts

English alphabet literate group

ACTIVE COMPARATOR

Individuals with self-reported understanding of English alphabet and recognition of ≥6/10 Sloan Letters

Diagnostic Test: Visual acuity assessment by ETDRS charts

Interventions

Visual acuity assessment by ETDRS charts DIAGNOSTIC_TEST

All participants must complete VA measurement of both eyes using 2 charts including the ETDRS letters chart and ETDRS numbers chart.

English alphabet illiterate group; English alphabet literate group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hong Kong residents
• Age 50 years or above
• Attending Southern District Screening program

You may not qualify if:

• BCVA 20/200 or below
• Any clinically relevant ocular disease that might affect visual acuity

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

HKSDS Program

Hong Kong, 000000, Hong Kong

Location

Related Publications (10)

• Bailey IL, Lovie JE. New design principles for visual acuity letter charts. Am J Optom Physiol Opt. 1976 Nov;53(11):740-5. doi: 10.1097/00006324-197611000-00006.

  PMID: 998716 BACKGROUND

• Ferris FL 3rd, Bailey I. Standardizing the measurement of visual acuity for clinical research studies: Guidelines from the Eye Care Technology Forum. Ophthalmology. 1996 Jan;103(1):181-2. doi: 10.1016/s0161-6420(96)30742-2. No abstract available.

  PMID: 8628551 BACKGROUND

• Kniestedt C, Stamper RL. Visual acuity and its measurement. Ophthalmol Clin North Am. 2003 Jun;16(2):155-70, v. doi: 10.1016/s0896-1549(03)00013-0.

  PMID: 12809155 BACKGROUND

• Chaikitmongkol V, Nanegrungsunk O, Patikulsila D, Ruamviboonsuk P, Bressler NM. Repeatability and Agreement of Visual Acuity Using the ETDRS Number Chart, Landolt C Chart, or ETDRS Alphabet Chart in Eyes With or Without Sight-Threatening Diseases. JAMA Ophthalmol. 2018 Mar 1;136(3):286-290. doi: 10.1001/jamaophthalmol.2017.6290.

  PMID: 29346499 BACKGROUND

• Koenig S, Tonagel F, Schiefer U, Bach M, Heinrich SP. Assessing visual acuity across five disease types: ETDRS charts are faster with clinical outcome comparable to Landolt Cs. Graefes Arch Clin Exp Ophthalmol. 2014 Jul;252(7):1093-9. doi: 10.1007/s00417-014-2670-y. Epub 2014 May 28.

  PMID: 24867313 BACKGROUND

• Treacy MP, Hurst TP, Conway M, Duignan ES, Dimitrov BD, Brennan N, Cassidy L. The early treatment in diabetic retinopathy study chart compared with the tumbling-E and Landolt-C. Ophthalmology. 2015 May;122(5):1062-3.e1. doi: 10.1016/j.ophtha.2014.11.024. Epub 2015 Jan 10. No abstract available.

  PMID: 25582784 BACKGROUND

• Kuo HK, Kuo MT, Tiong IS, Wu PC, Chen YJ, Chen CH. Visual acuity as measured with Landolt C chart and Early Treatment of Diabetic Retinopathy Study (ETDRS) chart. Graefes Arch Clin Exp Ophthalmol. 2011 Apr;249(4):601-5. doi: 10.1007/s00417-010-1461-3. Epub 2010 Jul 24.

  PMID: 20658145 BACKGROUND

• Ruamviboonsuk P, Tiensuwan M, Kunawut C, Masayaanon P. Repeatability of an automated Landolt C test, compared with the early treatment of diabetic retinopathy study (ETDRS) chart testing. Am J Ophthalmol. 2003 Oct;136(4):662-9. doi: 10.1016/s0002-9394(03)00394-5.

  PMID: 14516806 BACKGROUND

• Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care. 2005 Jun;20(2):187-91; discussion 191-3. doi: 10.1016/j.jcrc.2005.04.005.

  PMID: 16139163 BACKGROUND

• Universal C: Visual Acuity Measurement Standard. Visual Functions Committee 1984.

  BACKGROUND

Study Officials

• Nicholas Fung

  Department of Ophthalmology, HKU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Prospective randomized controlled trial

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 20, 2020
• Study Start: August 1, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: August 20, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within 1 year of publication
• Access Criteria: For research publisher

Locations

HK (1)