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.
Full Title of Study: “Reading Analysis in Ophthalmologic Patients: a Pilot Study”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Diagnostic
- Masking: None (Open Label)
- Study Primary Completion Date: January 1, 2020
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.
- Device: EyeTracker
- Patients with various ophthalmologic diseases (ERM, glaucoma, AMD, diabetic retinopathy) will undergo reading analysis using the EyeTracker
Arms, Groups and Cohorts
- Experimental: Ophthalmologic Disease
- Patients with glaucoma, AMD, diabetic maculopathy, epiretinal membranes, and healthy patients will undergo a reading analysis using the EyeTracker
Clinical Trial Outcome Measures
- Reading speed
- Time Frame: 12 months
- 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.
- Retinal perimetry
- Time Frame: 12 months
- Analysis of retinal fixation will be done using microperimetry.
Participating in This Clinical Trial
- 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
- 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)
Gender Eligibility: All
Minimum Age: 21 Years
Maximum Age: 105 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Prim. Prof. Dr. Oliver Findl, MBA
- Provider of Information About this Clinical Study
- Sponsor-Investigator: Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator – Vienna Institute for Research in Ocular Surgery
- Overall Contact(s)
- Stefan Palkovits, MD, 01 910 21-57573, email@example.com
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