Reading Analysis in Ophthalmologic Patients

Sponsor
Prim. Prof. Dr. Oliver Findl, MBA (Other)
Overall Status
Unknown status
CT.gov ID
NCT03750149
Collaborator
(none)
100
1
1
36
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: EyeTracker
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Reading Analysis in Ophthalmologic Patients: a Pilot Study
Actual Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Jan 1, 2020
Anticipated Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ophthalmologic Disease

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

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Retinal perimetry [12 months]

    Analysis of retinal fixation will be done using microperimetry.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 105 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

  • 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vienna Institute for Research in Ocular Surgery (VIROS) Vienna Austria 1140

Sponsors and Collaborators

  • Prim. Prof. Dr. Oliver Findl, MBA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier:
NCT03750149
Other Study ID Numbers:
  • TRC
First Posted:
Nov 21, 2018
Last Update Posted:
Feb 27, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 27, 2019