PresbyopiaDeDARTNCT04242836
Development and Validation of a Digital Optotype for Near Vision in Greek Language.
An observational study of Presbyopia and Low Vision, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
Primary objective of our study is to develop and validate a computer-based digital near-vision optotype based on the Greek version of the print MNREAD. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia, Low Vision, Near Vision
- What is being tested?
- MNREAD testing
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 28 Mar 2019to 28 Nov 2019
- How long will I take part?
- 15 Days
- 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
Who cannot join
- dyslexia
- attention-deficiency
- former diagnosis of mental diseases
- former diagnosis of psychiatric diseases
Trial locations and contacts
1 site in 1 country.
Greece1 site
University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100
About this study
Official title: Development and Validation of a Computer-based Digital Near-vision Optotype Based on the Greek Version of the Print MNREAD.
Primary objective of our study is to develop and validate a computer-based digital near-vision optotype based on the Greek version of the print MNREAD.
Read the detailed description
Present study aims to develop and validate a computer-based digital near-vision optotype based on the Greek version of the print MNREAD.
Specifically, it aims to evaluate the level of agreement between the conventional printed greek MNREAD chart and the corresponding digital chart, as well as test-retest reliability of the digital optotype.
To address these aims, four reading parameters measured with the print and the digital 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, Low Vision, Near Vision
- Being tested
- MNREAD testing
- Keywords
- digital near vision chart, critical print size, reading acuity, reading speed, digital Greek MNREAD
- Medical subject headings
- Presbyopia, Vision, Low, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MNREAD testingDiagnostic test
One randomly selected eye is included for each study participant. Participants respond to the near vision chart with defined environmental circumstances at 40cm viewing distance. All four parameters (RA, MRS, CPS and ACC) are evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Control group | 1. 70 patients with normal vision (NVG) with adequate literacy of written Greek language
2. 30 patients with low vision (LVG) with adequate literacy of written Greek language
These patients are tested on the printed Greek MNREAD Receives: Diagnostic Test: MNREAD testing | |
| Study group | The same patients as those in the control group (NVG, LVG) are tested on the digital version of the Greek MNREAD (DeDART) Receives: Diagnostic Test: MNREAD 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 the patient can read without making significant errors, and can be calculated by the following formula:
Acuity (in logMAR)= 1.4 - (sentences x 0.1) + (errors x 0.01).
Measured: through study completion, an average of 8 months
Maximum Reading Speed (MRS)
The patient's reading speed when reading is not limited by print size , and is calculated by averaging the speed of the sentences with print size larger than the CPS. [(in words per minute (wpm)]
Measured: through study completion, an average of 8 months
Critical Print Size (CPS)
The smallest print size at which patients can read with their MRS, and is identified as the print size of the sentence fulfilling this criterion: all of the following sentences are read at a speed that is 1.96 times the standard deviation below the average of the larger preceding sentences (that is the MRS). In other words, it is defined as the smallest print size that yields 90% of the MRS [(in logMAR)]
Measured: through study completion, an average of 8 months
Accessibility Index (ACC)
The mean reading speed measured across the 10 largest print sizes (1.3 to 0.4 logMAR) of the MNREAD Acuity Chart at 40 cm normalized by 200 wpm, which was the mean value for a group of 365 normally sighted young adults aged 18 to 39 years old.
Measured: through study completion, an average of 8 months
Secondary outcomes (2)
Intraclass Correlation Coefficients (ICCs) for study participants
Level of agreement between the print and the digital version are evaluated by calculation of the ICCs for the 4 reading parameters (RA, MRS, CPS, ACC).
Measured: through study completion, an average of 8 months
Test-retest Intraclass Correlation Coefficients (ICCs)
Test-retest reliability of the digital optotype is evaluated by ICCs for the 4 reading parameters (RA, MRS, CPS, ACC)..
Measured: through study completion, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start28 Mar 2019
- Primary completion28 Jun 2019
- Study completion28 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Labiris, Democritus University of Thrace
- Investigators
- Georgios Labiris, MD, PhD, Study chair, University Hospital of Alexandroupolis, Alexandroupolis, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242836
- Sponsor's protocol ID
- ES3/Th2/27-03-2019
- Acronym
- DeDART
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2020
- Last updated
- 27 Jan 2020
- 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 33102611
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Computer-based Digital Near-vision Optotype Based on the Greek Version of the Print MNREAD.
- ClinicalTrials.gov ID
- NCT04242836
- Acronym / sponsor ID
- DeDART / ES3/Th2/27-03-2019
- Conditions
- Presbyopia, Low Vision, Near Vision
- Keywords
- digital near vision chart, critical print size, reading acuity, reading speed, digital Greek MNREAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Nov 2019 (actual)
- First posted
- 27 Jan 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 a computer-based digital near-vision optotype based on the Greek version of the print MNREAD.
Detailed description
Present study aims to develop and validate a computer-based digital near-vision optotype based on the Greek version of the print MNREAD.
Specifically, it aims to evaluate the level of agreement between the conventional printed greek MNREAD chart and the corresponding digital chart, as well as test-retest reliability of the digital optotype.
To address these aims, four reading parameters measured with the print and the digital 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
- Target follow-up
- 15 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Diagnostic Test: MNREAD testing1. 70 patients with normal vision (NVG) with adequate literacy of written Greek language 2. 30 patients with low vision (LVG) with adequate literacy of written Greek language These patients are tested on the printed Greek MNREAD |
| Study group | – | Diagnostic Test: MNREAD testingThe same patients as those in the control group (NVG, LVG) are tested on the digital version of the Greek MNREAD (DeDART) |
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 (1 listed)
- adequate literacy of written Greek language
Key exclusion criteria (4 listed)
- dyslexia
- attention-deficiency
- former diagnosis of mental diseases
- former diagnosis of 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 |
|---|---|---|
| MNREAD testingOne randomly selected eye is included for each study participant. Participants respond to the near vision chart with defined environmental circumstances at 40cm viewing distance. All four parameters (RA, MRS, CPS and ACC) are evaluated. | Diagnostic test | Control group, Study group |
Primary outcome
Reading Acuity (RA)
Time frame: through study completion, an average of 8 months
The smallest print that the patient can read without making significant errors, and can be calculated by the following formula: Acuity (in logMAR)= 1.4 - (sentences x 0.1) + (errors x 0.01).
Maximum Reading Speed (MRS)
Time frame: through study completion, an average of 8 months
The patient's reading speed when reading is not limited by print size , and is calculated by averaging the speed of the sentences with print size larger than the CPS. [(in words per minute (wpm)]
Critical Print Size (CPS)
Time frame: through study completion, an average of 8 months
The smallest print size at which patients can read with their MRS, and is identified as the print size of the sentence fulfilling this criterion: all of the following sentences are read at a speed that is 1.96 times the standard deviation below the average of the larger preceding sentences (that is the MRS). In other words, it is defined as the smallest print size that yields 90% of the MRS [(in logMAR)]
Accessibility Index (ACC)
Time frame: through study completion, an average of 8 months
The mean reading speed measured across the 10 largest print sizes (1.3 to 0.4 logMAR) of the MNREAD Acuity Chart at 40 cm normalized by 200 wpm, which was the mean value for a group of 365 normally sighted young adults aged 18 to 39 years old.
2 secondary outcomes
Intraclass Correlation Coefficients (ICCs) for study participants
Time frame: through study completion, an average of 8 months
Test-retest Intraclass Correlation Coefficients (ICCs)
Time frame: through study completion, an average of 8 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 27 Jan 2020.
- Derived from this study: 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.
Related trials for Presbyopia
Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
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
University Hospital of Alexandroupolis, Alexandroupolis, Greece
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 Presbyopia and Low Vision, run by Democritus University of Thrace at 1 site 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 1 inclusion and 4 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 27 Jan 2020. 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 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 8 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 NCT04242836, which also lists 1 linked publication.
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 27 Jan 2020.