Reading Analysis in Ophthalmologic Patients

NCT ID: NCT03750149

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2021-01-01

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Ophthalmologic Disease

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

Group Type: EXPERIMENTAL

EyeTracker

Intervention Type: DEVICE

Patients with various ophthalmologic diseases (ERM, glaucoma, AMD, diabetic retinopathy) will undergo reading analysis using the EyeTracker

Interventions

EyeTracker

Patients with various ophthalmologic diseases (ERM, glaucoma, AMD, diabetic retinopathy) will undergo reading analysis using the EyeTracker

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prim. Prof. Dr. Oliver Findl, MBA

OTHER

Sponsor Role: lead

Responsible Party

Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Stefan Palkovits, MD

Role: CONTACT

office@viros.at

01 910 21-57573

Sahand Amir-Asgari, MD

Role: CONTACT

office@viros.at

01 910 21-57557

Facility Contacts

Stefan Palkovits, MD

Role: primary

office@viros.at

01 910 21-57573

Sahand Amir-Asgari, MD

Role: backup

office@viros.at

01 910 21-57557

Other Identifiers

TRC

Identifier Type: -

Identifier Source: org_study_id