Development and Validation of a Digital Optotype for Near Vision in Greek Language.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Development and Validation of a Computer-based Digital Near-vision Optotype Based on the Greek Version of the Print MNREAD.

Conditions
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Presbyopia, Low Vision, Near Vision

Intervention / Treatment
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* Diagnostic Test: MNREAD testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adequate literacy of written Greek language Exclusion Criteria: dyslexia attention-deficiency former diagnosis of mental diseases former diagnosis of psychiatric diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>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 printed Greek MNREAD | Diagnostic Test: MNREAD testing<br>* 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.<br>|
| Study group<br>The same patients as those in the control group (NVG, LVG) are tested on the digital version of the Greek MNREAD (DeDART) | Diagnostic Test: MNREAD testing<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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)] | 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)] | 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. | through study completion, an average of 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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).. | through study completion, an average of 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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digital near vision chart, critical print size, reading acuity, reading speed, digital Greek MNREAD