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Clinical Trials/NCT03750149
NCT03750149
Unknown
Not Applicable

Reading Analysis in Ophthalmologic Patients: a Pilot Study

Prim. Prof. Dr. Oliver Findl, MBA1 site in 1 country100 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Maculopathy
Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
Enrollment
100
Locations
1
Primary Endpoint
Reading speed
Last Updated
7 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
January 1, 2021
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
Responsible Party
Sponsor Investigator
Principal Investigator

Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Vienna Institute for Research in Ocular Surgery

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Retinal perimetry(12 months)

Study Sites (1)

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