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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03750149
Other study ID # TRC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date January 1, 2021

Study information

Verified date February 2019
Source Vienna Institute for Research in Ocular Surgery
Contact Stefan Palkovits, MD
Phone 01 910 21-57573
Email office@viros.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigation of the reading parameters and fixation behavior in patients with different ocular diseases (age-related macular degeneration, glaucoma, diabetic maculopathy, epiretinal membrane) and healthy subjects. In addition, fixation analysis and retinal sensitivity measurements will be done with a microperimeter in each subject.


Description:

Reading is a complex function. It requires a proper retinal image that is received by the brain. There it is analyzed for letter and word recognition and then the semantics is detected. Reading speed slows down when letters are blurred, or do not have enough contrast or luminance or when binocular fusion is hampered. Hence, it is obvious that reading ability is reduced in patients with various ocular diseases. Especially, pathologies effecting the posterior pole (central and paracentral vision) might impair reading parameters significantly.

Recently, the Eyetracker Eyelink 1000 (SR Research Ltd, Canada) became available. It´s application was described previously. Briefly, a high-speed infrared camera detects the position of eye (pupil and corneal reflex) and in turn the direction of gaze 500 times per second. During the calibration process the position can be linked to the position on a screen where, for instance, a text or a fixation target can be projected. Direction of gaze is recorded during the reading process and the gathered data are analyzed.

Fixation ability was assessed using Eyelink 1000 in patients with age-related macular degeneration. It was shown that fixation is related to visual function. The worse eye showed reduced fixation ability which is improved during binocular fixation. This study investigates reading parameters in patients with various ocular diseases.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date January 1, 2021
Est. primary completion date January 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 105 Years
Eligibility Inclusion Criteria:

- Age 21 and older

- Absence of ocular disease (Group 1)

- Present ocular disease (age-related macular degeneration, glaucoma, diabetic maculopathy, epiretinal membrane/macular hole) as judged by the investigator (Group 2 - 5)

- Maximum of allowed cylinder-power in the spectacles: +1.50D

Exclusion Criteria:

- Ocular pathologies, that may interfere with study measurements, such as corneal scars

- In case of pregnancy (pregnancy test will be taken prior to inclusion into the study in women of reproductive age)

Study Design


Intervention

Device:
EyeTracker
Patients with various ophthalmologic diseases (ERM, glaucoma, AMD, diabetic retinopathy) will undergo reading analysis using the EyeTracker

Locations

Country Name City State
Austria Vienna Institute for Research in Ocular Surgery (VIROS) Vienna

Sponsors (1)

Lead Sponsor Collaborator
Prim. Prof. Dr. Oliver Findl, MBA

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reading speed Reading speed (words per minute) will be analysed using the EyeTracker device. The patient has to read 4 texts with different contrast levels. The faster the patient can read a text, the better the results. 12 months
Secondary Retinal perimetry Analysis of retinal fixation will be done using microperimetry. 12 months
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