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

Sponsor

Democritus University of Thrace (Other)

Overall Status

Completed

CT.gov ID

NCT04242836

Collaborator

(none)

100

Enrollment

Location

Actual Duration (Months)

12.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia Low Vision Near Vision	Diagnostic Test: MNREAD testing

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

Study Type:

Observational [Patient Registry]

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 28, 2019

Actual Primary Completion Date :

Jun 28, 2019

Actual Study Completion Date :

Nov 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
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 printed Greek MNREAD	Diagnostic Test: MNREAD testing 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 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 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.

Arm

Intervention/Treatment

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 printed Greek MNREAD

Diagnostic Test: MNREAD testing

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

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

Outcome Measures

Primary Outcome Measures

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).
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)]
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)]
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.

Secondary Outcome Measures

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)..