Reading Analysis in Ophthalmologic Patients

Glaucoma Clinical Trial

Official title:

Reading Analysis in Ophthalmologic Patients: a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03750149
• Other study ID #: TRC
• Status: Recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Diabetic Maculopathy
• Epiretinal Membrane
• Glaucoma
• Macular Degeneration

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