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

Presbyopia Clinical Trial

— DeDART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04242836
• Other study ID #: ES3/Th2/27-03-2019
• Status: Completed
• Start date: March 28, 2019
• Est. completion date: November 28, 2019

Study information

• Verified date: January 2020
• Source: Democritus University of Thrace
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 28, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• adequate literacy of written Greek language

Exclusion Criteria:

• dyslexia

• attention-deficiency

• former diagnosis of mental diseases

• former diagnosis of psychiatric diseases

Related Conditions & MeSH terms

• Low Vision
• Myopia
• Near Vision
• Presbyopia
• Vision, Low

Intervention

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.

Locations

Country	Name	City	State
Greece	University Hospital of Alexandroupolis	Alexandroupolis	Evros

Sponsors (1)

Lead Sponsor	Collaborator
Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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