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Reading Analysis in Ophthalmologic Patients

Primary Purpose

Diabetic Maculopathy, Age Related Macular Degeneration, Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
EyeTracker
Sponsored by
Prim. Prof. Dr. Oliver Findl, MBA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetic Maculopathy focused on measuring Diabetic Maculopathy, Age Related Macular Degeneration, Glaucoma, Epiretinal membrane, Reading analysis

Eligibility Criteria

21 Years - 105 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Vienna Institute for Research in Ocular Surgery (VIROS)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ophthalmologic Disease

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Retinal perimetry
Analysis of retinal fixation will be done using microperimetry.

Full Information

First Posted
November 20, 2018
Last Updated
February 26, 2019
Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
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1. Study Identification

Unique Protocol Identification Number
NCT03750149
Brief Title
Reading Analysis in Ophthalmologic Patients
Official Title
Reading Analysis in Ophthalmologic Patients: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prim. Prof. Dr. Oliver Findl, MBA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Maculopathy, Age Related Macular Degeneration, Glaucoma, Epiretinal Membrane
Keywords
Diabetic Maculopathy, Age Related Macular Degeneration, Glaucoma, Epiretinal membrane, Reading analysis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ophthalmologic Disease
Arm Type
Experimental
Arm Description
Patients with glaucoma, AMD, diabetic maculopathy, epiretinal membranes, and healthy patients will undergo a reading analysis using the EyeTracker
Intervention Type
Device
Intervention Name(s)
EyeTracker
Intervention Description
Patients with various ophthalmologic diseases (ERM, glaucoma, AMD, diabetic retinopathy) will undergo reading analysis using the EyeTracker
Primary Outcome Measure Information:
Title
Reading speed
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Retinal perimetry
Description
Analysis of retinal fixation will be done using microperimetry.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Palkovits, MD
Phone
01 910 21-57573
Email
office@viros.at
First Name & Middle Initial & Last Name or Official Title & Degree
Sahand Amir-Asgari, MD
Phone
01 910 21-57557
Email
office@viros.at
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS)
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Palkovits, MD
Phone
01 910 21-57573
Email
office@viros.at
First Name & Middle Initial & Last Name & Degree
Sahand Amir-Asgari, MD
Phone
01 910 21-57557
Email
office@viros.at

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Reading Analysis in Ophthalmologic Patients

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