- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03102073
Validation of Romanian Version of Radner Reading Charts
January 11, 2018 updated by: Opera CRO, a TIGERMED Group Company
Interventional, parallel groups, single center trial with a prospective design
Study Overview
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Timis
-
Timisoara, Timis, Romania, 300209
- Opera Contract Research Organization SRL
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Radner test
reading speed evaluation
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reading speed
Time Frame: 2-4 months postsurgery
|
in words per minute
|
2-4 months postsurgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reading errors
Time Frame: 2-4 months postsurgery
|
count errors at each sentence
|
2-4 months postsurgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Serban Rosu, MD, OPERA CRO
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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