Visual AcuityNCT03102073
Validation of Romanian Version of Radner Reading Charts
An observational study of Visual Acuity, run by Opera CRO, a TIGERMED Group Company at 1 site in Romania.
Trial summary
Interventional, parallel groups, single center trial with a prospective design Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- Radner test
- How many people
- 70 participants
- Where
- 1 siteRomania
- Study dates
- 1 Dec 2016to 30 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy patients
Who may be able to join
- 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
Who cannot join
- Ocular pathologies that can influence the study results
- Alcohol ingestion
- Concomitant medication that can influence visual acuity
Trial locations and contacts
1 site in 1 country.
Romania1 site
Opera Contract Research Organization Srl
Timișoara, Timiș County, 300209
About this study
Interventional, parallel groups, single center trial with a prospective design
Read the 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.
- Conditions
- Visual Acuity
- Being tested
- Radner test
- Keywords
- Reading speed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radner testDiagnostic test
Also called Validation of the Romanian version-Radner Reading Charts
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Radner test | reading speed evaluation Receives: Diagnostic Test: Radner test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading speed
in words per minute
Measured: 2-4 months postsurgery
Secondary outcomes (1)
Reading errors
count errors at each sentence
Measured: 2-4 months postsurgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start1 Dec 2016
- Primary completion27 Feb 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual AcuityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Opera CRO, a TIGERMED Group Company
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serban Rosu, MD, Study director, OPERA CRO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102073
- Sponsor's protocol ID
- OPRAD/0116/MD
- Status last verified
- Mar 2017
- First submitted
- 17 Mar 2017
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Romanian Version of Radner Reading Charts
- ClinicalTrials.gov ID
- NCT03102073
- Acronym / sponsor ID
- OPRAD/0116/MD
- Conditions
- Visual Acuity
- Keywords
- Reading speed
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Opera CRO, a TIGERMED Group CompanyUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 27 Feb 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radner test | – | Diagnostic Test: Radner testreading speed evaluation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Ocular pathologies that can influence the study results
- Alcohol ingestion
- Concomitant medication that can influence visual acuity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radner testAlso: Validation of the Romanian version-Radner Reading Charts* 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. | Diagnostic test | Radner test |
Primary outcome
Reading speed
Time frame: 2-4 months postsurgery
in words per minute
1 secondary outcome
Reading errors
Time frame: 2-4 months postsurgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serban Rosu, MD study director
OPERA CRO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Acuity, run by Opera CRO, a TIGERMED Group Company at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reading speed (time frame: 2-4 months postsurgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.