Development and Validation of a Digital Optotype for Near Vision in Greek Language.
- Conditions
- PresbyopiaLow VisionNear Vision
- Interventions
- Diagnostic Test: MNREAD testing
- Registration Number
- NCT04242836
- Lead Sponsor
- Democritus University of Thrace
- Brief 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.
- 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:
1. Reading Acuity (RA)
2. Maximum Reading Speed (MRS)
3. Critical Print Size (CPS)
4. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- adequate literacy of written Greek language
- dyslexia
- attention-deficiency
- former diagnosis of mental diseases
- former diagnosis of psychiatric diseases
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control group MNREAD testing 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 Study group MNREAD testing The same patients as those in the control group (NVG, LVG) are tested on the digital version of the Greek MNREAD (DeDART)
- Primary Outcome Measures
Name Time Method Accessibility Index (ACC) 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.
Reading Acuity (RA) 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).Critical Print Size (CPS) 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 \[(in logMAR)\]
Maximum Reading Speed (MRS) 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. \[(in words per minute (wpm)\]
- Secondary Outcome Measures
Name Time Method Intraclass Correlation Coefficients (ICCs) for study participants through study completion, an average of 8 months 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).
Test-retest Intraclass Correlation Coefficients (ICCs) through study completion, an average of 8 months Test-retest reliability of the digital optotype is evaluated by ICCs for the 4 reading parameters (RA, MRS, CPS, ACC)..
Trial Locations
- Locations (1)
University Hospital of Alexandroupolis
🇬🇷Alexandroupolis, Evros, Greece