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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 CRO, a TIGERMED Group Company

Tracking Information
First Submitted Date March 17, 2017
First Posted Date April 5, 2017
Last Update Posted Date January 16, 2018
Actual Study Start Date December 1, 2016
Actual Primary Completion Date February 27, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 29, 2017)
Reading speed [ Time Frame: 2-4 months postsurgery ]
in words per minute
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 29, 2017)
Reading errors [ Time Frame: 2-4 months postsurgery ]
count errors at each sentence
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validation of Romanian Version of Radner Reading Charts
Official Title Validation of Romanian Version of Radner Reading Charts
Brief Summary Interventional, parallel groups, single center trial with a prospective design
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
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy patients
Condition 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.
Other Name: Validation of the Romanian version-Radner Reading Charts
Study Groups/Cohorts Radner test
reading speed evaluation
Intervention: Diagnostic Test: Radner test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 29, 2017)
70
Original Actual Enrollment Same as current
Actual Study Completion Date March 30, 2017
Actual Primary Completion Date February 27, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Romania
Removed Location Countries  
 
Administrative Information
NCT Number NCT03102073
Other Study ID Numbers OPRAD/0116/MD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Opera CRO, a TIGERMED Group Company
Study Sponsor Opera CRO, a TIGERMED Group Company
Collaborators Not Provided
Investigators
Study Director: Serban Rosu, MD OPERA CRO
PRS Account Opera CRO, a TIGERMED Group Company
Verification Date March 2017