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Validation of Romanian Version of Radner Reading Charts

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ClinicalTrials.gov Identifier: NCT03102073
Recruitment Status : Completed
First Posted : April 5, 2017
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Opera Contract Research Organization SRL

Brief Summary:
Interventional, parallel groups, single center trial with a prospective design

Condition or disease Intervention/treatment
Visual Acuity 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
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Validation of Romanian Version of Radner Reading Charts
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : February 27, 2017
Actual Study Completion Date : March 30, 2017

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 Name: Validation of the Romanian version-Radner Reading Charts




Primary Outcome Measures :
  1. Reading speed [ Time Frame: 2-4 months postsurgery ]
    in words per minute


Secondary Outcome Measures :
  1. Reading errors [ Time Frame: 2-4 months postsurgery ]
    count errors at each sentence



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy patients
Criteria

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

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): NCT03102073


Locations
Romania
Opera Contract Research Organization Srl
Timisoara, Timis, Romania, 300209
Sponsors and Collaborators
Opera Contract Research Organization SRL
Investigators
Study Director: Serban Rosu, MD OPERA CRO

Responsible Party: Opera Contract Research Organization SRL
ClinicalTrials.gov Identifier: NCT03102073     History of Changes
Other Study ID Numbers: OPRAD/0116/MD
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Opera Contract Research Organization SRL:
Reading speed