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| Name | Class |
|---|---|
| University of Thessaly | OTHER |
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Primary objective of this study is the development and validation of a web-based application for the examination of the distance visual acuity of normal- and low-vision patients.
Present study aims to develop and validate a web-based digital distance visual acuity test (Democritus Distance Vision Test - DDVIT). DDVIT is an application, which will be easily accessed through a simple internet connection. This application will provide the possibility of a simple but reliable examination of patients, establishing a commonly accepted way of measuring the distance visual acuity among rural doctors, general practitioners and ophthalmologists.
Specifically, present study aims to develop a new online distance visual acuity test (DDVIT) according to the standards of the Early Treatment Diabetic Retinopathy Study (ETDRS) test and to evaluate the level of agreement between the two visual acuity tests, as well as the test-retest reliability of the online DDVIT visual acuity test.
The first part of the study is the development of the online visual acuity test (letters, numbers, symbols) including the following smart features:
Adjustment of the font size according to the size of the computer screen used for the examination
Real time calculation of the patient-screen distance through a face detection system
Automatic calculation of the reading time of each line (each logMAR)
Entering the number of patient's reading errors for each line
Automatic calculation of the visual acuity in the following score units:
The calculation of various reading parameters resulting from the aforementioned features (visual acuity score in different units, reading duration (in sec) and number of errors for each slide (line), patient-screen distance for each slide) will be performed after the end of the examination. Except for the html format, a file in the format of Microsoft Excel and Pdf are also generated.
The second part of this study is the clinical validation of the DDVIT visual acuity test. In this part, the reading acuity measured with the DDVIT and ETDRS test are compared.
All the comparisons will take place in two groups: a) a Normal Vision Group (NVG), and b) a Low Vision Group (LVG) in order to estimate the visual acuity in a population with a wide range of vision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | 70 patients with normal vision (NVG) 30 patients with low vision (LVG) These patients will be tested on the DDVIT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DDVIT testing | Diagnostic Test | One randomly selected eye will be included for each study participant. Participants respond to the DDVIT test in standard environmental lighting conditions at 4 m viewing distance. Visual acuity will be evaluated. |
| Measure | Description | Time Frame |
|---|---|---|
| Distance visual acuity using DDVIT vision test | The distance visual acuity of the one randomly selected eye of each participant will be evaluated by the examiner using DDVIT vision test. | 4 months |
| Distance visual acuity using ETDRS vision test | The distance visual acuity of the same eye of each participant will be evaluated by the same examiner using the web-based ETDRS vision test under the same predetermined environmental lighting conditions. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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Normal- and low-sighted participants aged 18 to 75 years.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Georgios Labiris, MD, PhD | Contact | 00302551030405 | labiris@usa.net | |
| Eirini - Kanella Panagiotopoulou, MD | Contact | 00306978730858 | eipanagi@med.duth.gr |
| Name | Affiliation | Role |
|---|---|---|
| Georgios Labiris, MD, PhD | Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, University Hospital of Alexandroupolis | Recruiting | Alexandroupoli | Evros | 68100 | Greece |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D015354 | Vision, Low |
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ETDRS testing | Diagnostic Test | The same eye is included for each study participant. Participants respond to the standard ETDRS chart of our Ophthalmology Department in standard environmental lighting conditions at 4 m viewing distance. Visual acuity will be evaluated. |
|
| Department of Computer Science and Biomedical Informatics, University of Thessaly | Not yet recruiting | LamÃa | Thessaly | 35100 | Greece |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |