Clinical trial NCT03750149: Reading Analysis in Ophthalmologic Patients
Official title: Reading Analysis in Ophthalmologic Patients: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Maculopathy
Age Related Macular Degeneration
Glaucoma
Epiretinal Membrane
Keywords: Diabetic Maculopathy
Age Related Macular Degeneration
Glaucoma
Epiretinal membrane
Reading analysis
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: Reading speed
timeFrame: 12 months
Secondary outcomes:
measure: Retinal perimetry
timeFrame: 12 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery (VIROS)
Study officials:
References: