Validation of Romanian Version of Radner Reading Charts

Visual Acuity Clinical Trial

Official title:

Validation of Romanian Version of Radner Reading Charts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03102073
• Other study ID #: OPRAD/0116/MD
• Status: Completed
• Phase: N/A
• First received: March 17, 2017
• Last updated: January 11, 2018
• Start date: December 1, 2016
• Est. completion date: March 30, 2017

Study information

• Verified date: March 2017
• Source: Opera Contract Research Organization SRL
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Interventional, parallel groups, single center trial with a prospective design

Description:

The "Radner Reading Charts" have been developed on the basis of the concept of "sentence optotypes" for the standardized examination of reading acuity and reading speed. Print sizes are logarithmically scaled (LogRAD) to permit statistical analysis, and the results obtained can be compared to other logarithmically scaled vision systems (e.g., LogMAR). To guarantee accurate, reproducible and standardized measurements of reading acuity and reading speed at every viewing distance, "sentence optotypes" have been created to minimize the variations between the test items and to keep the geometric proportions as constant as possible at all distances. Through interdisciplinary cooperation, a series of test sentences were developed that are highly comparable in terms of the number of words (14 words), as well as the word length, number of syllables, position of words, lexical difficulty and syntactical complexity. The most similar sentences were statistically selected for the Radner Reading Charts.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 30, 2017
• Est. primary completion date: February 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Men or women aged =18 years

• Visual acuity = 20/20 Snellen in each eye

• Average daily reading time for students 5-7 hours and for non-students 0,5-2 hours

• Willingness to provide signed informed consent

Exclusion Criteria:

• Ocular pathologies that can influence the study results

• Alcohol ingestion

• Concomitant medication that can influence visual acuity

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Diagnostic Test:
• Radner test
The A5 reading booklet is held by the subject The subject is instructed to read sentence by sentence, by turning consecutively the pages of the booklet (on the first side is the number of sentence and the backward side contains the sentence) The subject is instructed to read the sentences aloud as quickly and accurately as possible to the end, and to not correct reading errors. One assessor is writing the reading time and records any reading errors on the scoring sheet while the second assessor is audio recording the operation Stop criterion: reading time longer than 20 seconds or severe errors.

Locations

Country	Name	City	State
Romania	Opera Contract Research Organization Srl	Timisoara	Timis

Sponsors (1)

Lead Sponsor	Collaborator
Opera Contract Research Organization SRL

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reading speed	in words per minute	2-4 months postsurgery
Secondary	Reading errors	count errors at each sentence	2-4 months postsurgery