Reading Analysis in Ophthalmologic Patients

Not Applicable

• Conditions: Age Related Macular Degeneration; Glaucoma; Diabetic Maculopathy; Epiretinal Membrane
• Interventions: Device: EyeTracker

• Registration Number: NCT03750149
• Lead Sponsor: Prim. Prof. Dr. Oliver Findl, MBA

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-11-20
• Study First Submitted QC: 2018-11-20
• Study First Posted: 2018-11-21
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-27
• Primary Completion: 2020-01-01
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ophthalmologic Disease	EyeTracker	Patients with glaucoma, AMD, diabetic maculopathy, epiretinal membranes, and healthy patients will undergo a reading analysis using the EyeTracker

Primary Outcome Measures

Name	Time	Method
Reading speed	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 Outcome Measures

Name	Time	Method
Retinal perimetry	12 months	Analysis of retinal fixation will be done using microperimetry.

Trial Locations

Locations (1)

Vienna Institute for Research in Ocular Surgery (VIROS); 🇦🇹 Vienna, Austria