PresbyopiawDDARTNCT04618224
Development and Validation of an Internet-based Near and Intermediate-vision Reading Test
An observational study of Presbyopia and Refractive Errors, run by Democritus University of Thrace at 2 sites in Greece.
Trial summary
Primary objective of our study is to develop and validate an internet-based digital near and intermediate-vision reading test in the greek language. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia, Refractive Errors, Low Vision
- What is being tested?
- DDART Testing and wDDART Testing
- How many people
- 100 participants
- Where
- 2 sitesGreece
- Study dates
- 2 Dec 2020to 10 Feb 2021
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal- and low-sighted participants aged 18 to 75 years
Who may be able to join
- Adequate literacy of written Greek language
- Age between 18 to 75 years
Who cannot join
- Dyslexia
- Attention-deficiency
- Former diagnosis of mental and/or psychiatric diseases
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Department of Ophthalmology, University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100
Department of Computer Science and Biomedical Informatics, University of Thessaly
Lamía, Thessaly, 35100
About this study
Official title: Introduction of an Internet-based Near and Intermediate-vision Reading Test for Greek-speaking Normal and Low Vision Adults (wDDART): Development and Validation.
Primary objective of our study is to develop and validate an internet-based digital near and intermediate-vision reading test in the greek language.
Read the detailed description
Present study aims to develop and validate a computer-based digital near-vision reading test (web Democritus Digital Acuity Reading Test - wDDART) based on the validated digital DDART.
Specifically, present study aims to develop a new online reading test (wDDART) based on the corresponding digital DDART reading test for Windows and to evaluate the level of agreement between the two reading tests, as well as test-retest reliability of the online wDDART reading test.
The first part of the study is the development of the online reading test, which will include the following new smart features:
- Automatic calculation of the reading time of each sentence (each logMAR)
- Automatic calculation of the basic reading parameters - RA, MRS, CPS, ACC - immediately after the completion of the examination
- Adjustment of the font size according to the size of the computer screen used for the examination
- Real time calculation of the patient-screen distance through a face detection system
The second part of this study is the clinical validation of the online wDDART reading test. In this part, four reading parameters measured with the digital and the online version are compared. These parameters are the following:
- Reading Acuity (RA)
- Maximum Reading Speed (MRS)
- Critical Print Size (CPS)
- Accessibility Index (ACC) All the comparisons take place in two groups: a) a Normal Vision Group (NVG), and b) a Low Vision Group (LVG) in order to estimate the reading capacity in a population with a wide range of vision.
- Conditions
- Presbyopia, Refractive Errors, Low Vision, Near Vision, Reading
- Being tested
- DDART Testing, wDDART Testing
- Keywords
- internet-based digital reading test, smart features, face detection, reading acuity, reading speed, critical print size
- Medical subject headings
- Presbyopia, Refractive Errors, Vision, Low, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DDART TestingDiagnostic test
One randomly selected eye is included for each study participant. Participants respond to the DDART near vision test with defined environmental conditions at 40 cm viewing distance. All four parameters (RA, MRS, CPS and ACC) are evaluated.
wDDART TestingDiagnostic test
One randomly selected eye is included for each study participant. Participants respond to the wDDART near vision test with defined environmental conditions at 40 cm viewing distance. All four parameters (RA, MRS, CPS and ACC) are evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Control group | * 70 patients with normal vision (NVG) with adequate literacy of written Greek language
* 30 patients with low vision (LVG) with adequate literacy of written Greek language
These patients are tested on the digital reading test DDART. Receives: Diagnostic Test: DDART Testing | |
| Study group | The same patients as those in the control group (NVG, LVG) are tested on the online version of the Greek digital reading test DDART (wDDART). Receives: Diagnostic Test: wDDART Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading Acuity (RA)
The smallest print that can be read by the patient easily (measured in logMAR). It is calculated by the following formula:
RA = 1.4 - (sentences x 0.1) + (errors x 0.01).
Measured: through study completion, an average of 3 months
Maximum Reading Speed (MRS)
The patient's reading speed (measured in wpm) when reading is not limited by print size. It is calculated by averaging the reading speed of the sentences with print size larger than the CPS.
Measured: through study completion, an average of 3 months
Critical Print Size (CPS)
The smallest print size (measured in logMAR) that can be read with the MRS, i.e., with speed greater than or equal to the average reading speed of the larger logMAR print sentences minus 1.96 times the standard deviation (SD) of the reading speed of these sentences.
Measured: through study completion, an average of 3 months
Accessibility Index (ACC)
The mean reading speed of the 10 largest print sizes at 40 cm (1.3 to 0.4 logMAR), divided by 200 wpm, which is the mean reading speed of normally sighted young adults aged 18 to 39 years old. This parameter was designed for better evaluation of one's access to text across the range of the 10 most common print sizes found in everyday life. For instance, a value of 0 means no access to commonly encountered printed material, while 1.0 is the mean value for normally sighted young adults that indicates reading fluency within the everyday life print sizes.
Measured: through study completion, an average of 3 months
Secondary outcomes (1)
Intraclass Correlation Coefficients (ICCs) for study participants
Level of agreement between the digital and the online version are evaluated by calculation of the ICCs for the 4 reading parameters (RA, MRS, CPS, ACC).
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start2 Dec 2020
- Primary completion15 Jan 2021
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PresbyopiaStudies 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Collaborators
- University of Thessaly
- Responsible party
- Principal investigator, Georgios Labiris, Democritus University of Thrace
- Investigators
- Georgios Labiris, MD, PhD, Study chair, Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618224
- Sponsor's protocol ID
- ES13/Th29/22-10-2020
- Acronym
- wDDART
- Status last verified
- Feb 2021
- First submitted
- 31 Oct 2020
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Labiris G, Panagiotopoulou EK, Chatzimichael E, Tzinava M, Mataftsi A, Delibasis K. Introduction of a digital near-vision reading test for normal and low vision adults: development and validation. Eye Vis (Lond). 2020 Oct 22;7:51. doi: 10.1186/s40662-020-00216-0. eCollection 2020.
PubMed 33102611Labiris G, Panagiotopoulou EK, Duzha E, Tzinava M, Perente A, Konstantinidis A, Delibasis K. Development and Validation of a Web-Based Reading Test for Normal and Low Vision Patients. Clin Ophthalmol. 2021 Sep 22;15:3915-3929. doi: 10.2147/OPTH.S314943. eCollection 2021.
PubMed 34588763
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introduction of an Internet-based Near and Intermediate-vision Reading Test for Greek-speaking Normal and Low Vision Adults (wDDART): Development and Validation.
- ClinicalTrials.gov ID
- NCT04618224
- Acronym / sponsor ID
- wDDART / ES13/Th29/22-10-2020
- Conditions
- Presbyopia, Refractive Errors, Low Vision, Near Vision, Reading
- Keywords
- internet-based digital reading test, smart features, face detection, reading acuity, reading speed, critical print size
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Collaborators
- University of Thessaly
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 5 Nov 2020 (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.
Primary objective of our study is to develop and validate an internet-based digital near and intermediate-vision reading test in the greek language.
Detailed description
Present study aims to develop and validate a computer-based digital near-vision reading test (web Democritus Digital Acuity Reading Test - wDDART) based on the validated digital DDART.
Specifically, present study aims to develop a new online reading test (wDDART) based on the corresponding digital DDART reading test for Windows and to evaluate the level of agreement between the two reading tests, as well as test-retest reliability of the online wDDART reading test.
The first part of the study is the development of the online reading test, which will include the following new smart features:
- Automatic calculation of the reading time of each sentence (each logMAR)
- Automatic calculation of the basic reading parameters - RA, MRS, CPS, ACC - immediately after the completion of the examination
- Adjustment of the font size according to the size of the computer screen used for the examination
- Real time calculation of the patient-screen distance through a face detection system
The second part of this study is the clinical validation of the online wDDART reading test. In this part, four reading parameters measured with the digital and the online version are compared. These parameters are the following:
- Reading Acuity (RA)
- Maximum Reading Speed (MRS)
- Critical Print Size (CPS)
- Accessibility Index (ACC) All the comparisons take place in two groups: a) a Normal Vision Group (NVG), and b) a Low Vision Group (LVG) in order to estimate the reading capacity in a population with a wide range of vision.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Diagnostic Test: DDART Testing* 70 patients with normal vision (NVG) with adequate literacy of written Greek language * 30 patients with low vision (LVG) with adequate literacy of written Greek language These patients are tested on the digital reading test DDART. |
| Study group | – | Diagnostic Test: wDDART TestingThe same patients as those in the control group (NVG, LVG) are tested on the online version of the Greek digital reading test DDART (wDDART). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal- and low-sighted participants aged 18 to 75 years
Key inclusion criteria (2 listed)
- Adequate literacy of written Greek language
- Age between 18 to 75 years
Key exclusion criteria (3 listed)
- Dyslexia
- Attention-deficiency
- Former diagnosis of mental and/or psychiatric diseases
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 |
|---|---|---|
| DDART TestingOne randomly selected eye is included for each study participant. Participants respond to the DDART near vision test with defined environmental conditions at 40 cm viewing distance. All four parameters (RA, MRS, CPS and ACC) are evaluated. | Diagnostic test | Control group |
| wDDART TestingOne randomly selected eye is included for each study participant. Participants respond to the wDDART near vision test with defined environmental conditions at 40 cm viewing distance. All four parameters (RA, MRS, CPS and ACC) are evaluated. | Diagnostic test | Study group |
Primary outcome
Reading Acuity (RA)
Time frame: through study completion, an average of 3 months
The smallest print that can be read by the patient easily (measured in logMAR). It is calculated by the following formula: RA = 1.4 - (sentences x 0.1) + (errors x 0.01).
Maximum Reading Speed (MRS)
Time frame: through study completion, an average of 3 months
The patient's reading speed (measured in wpm) when reading is not limited by print size. It is calculated by averaging the reading speed of the sentences with print size larger than the CPS.
Critical Print Size (CPS)
Time frame: through study completion, an average of 3 months
The smallest print size (measured in logMAR) that can be read with the MRS, i.e., with speed greater than or equal to the average reading speed of the larger logMAR print sentences minus 1.96 times the standard deviation (SD) of the reading speed of these sentences.
Accessibility Index (ACC)
Time frame: through study completion, an average of 3 months
The mean reading speed of the 10 largest print sizes at 40 cm (1.3 to 0.4 logMAR), divided by 200 wpm, which is the mean reading speed of normally sighted young adults aged 18 to 39 years old. This parameter was designed for better evaluation of one's access to text across the range of the 10 most common print sizes found in everyday life. For instance, a value of 0 means no access to commonly encountered printed material, while 1.0 is the mean value for normally sighted young adults that indicates reading fluency within the everyday life print sizes.
1 secondary outcome
Intraclass Correlation Coefficients (ICCs) for study participants
Time frame: through study completion, an average of 3 months
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 Feb 2021.
- Results publication: PubMed 33102611Labiris G, Panagiotopoulou EK, Chatzimichael E, Tzinava M, Mataftsi A, Delibasis K. Introduction of a digital near-vision reading test for normal and low vision adults: development and validation. Eye Vis (Lond). 2020 Oct 22;7:51. doi: 10.1186/s40662-020-00216-0. eCollection 2020.
- Derived from this study: PubMed 34588763Labiris G, Panagiotopoulou EK, Duzha E, Tzinava M, Perente A, Konstantinidis A, Delibasis K. Development and Validation of a Web-Based Reading Test for Normal and Low Vision Patients. Clin Ophthalmol. 2021 Sep 22;15:3915-3929. doi: 10.2147/OPTH.S314943. eCollection 2021.
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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.
Georgios Labiris, MD, PhD study chair
Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Presbyopia and Refractive Errors, run by Democritus University of Thrace at 2 sites in Greece.
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 2 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 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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 Acuity (RA) (time frame: through study completion, an average of 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04618224, which also lists 2 linked publications.
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 Feb 2021.