Validation of Romanian Version of Radner Reading Charts

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

Study Overview

• Status: Completed
• Conditions: Visual Acuity
• Intervention / Treatment: Diagnostic test: Radner test

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Romania
  • Timis
    • Timisoara, Timis, Romania, 300209
      • Opera Contract Research Organization SRL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Radner test; reading speed evaluation

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.; Other Names: Validation of the Romanian version-Radner Reading Charts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reading speed	in words per minute	2-4 months postsurgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reading errors	count errors at each sentence	2-4 months postsurgery

Collaborators and Investigators

• Sponsor: Opera CRO, a TIGERMED Group Company
• Investigators: Study Director: Serban Rosu, MD, OPERA CRO

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): February 27, 2017
• Study Completion (Actual): March 30, 2017

Study Registration Dates

• First Submitted: March 17, 2017
• First Submitted That Met QC Criteria: March 29, 2017
• First Posted (Actual): April 5, 2017

Study Record Updates

• Last Update Posted (Actual): January 16, 2018
• Last Update Submitted That Met QC Criteria: January 11, 2018
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Reading speed
• Other Study ID Numbers: OPRAD/0116/MD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No