CClinicalTrials.gg
Status unknownNCT03750149Updated Feb 27, 2019

Reading Analysis in Ophthalmologic Patients

An interventional study of EyeTracker in Diabetic Maculopathy, Age Related Macular Degeneration and Glaucoma, sponsored by Prim. Prof. Dr. Oliver Findl, MBA. Status unknown at 1 site in Austria. Open to participants aged 21 Years to 105 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-27.

Sponsored by Prim. Prof. Dr. Oliver Findl, MBA · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jan 2018, registered Nov 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
21 Years to 105 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Diabetic Maculopathy
  • Age Related Macular Degeneration
  • Glaucoma
  • Epiretinal membrane
  • Reading analysis
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's planned enrollment of 100 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Prim. Prof. Dr. Oliver Findl, MBA is the lead sponsor of 38 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 105 Years
Sexes eligible
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 - 5)
  • Maximum of allowed cylinder-power in the spectacles: +1.50D

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Ophthalmologic Disease

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

    Device: EyeTracker

Interventions

  • DeviceEyeTracker

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

Secondary outcomes

  1. Retinal perimetry

    Analysis of retinal fixation will be done using microperimetry.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Vienna Institute for Research in Ocular Surgery (VIROS)
    Vienna, 1140, Austria
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03750149
Lead sponsor
Prim. Prof. Dr. Oliver Findl, MBA
Responsible party
Prim. Prof. Dr. Oliver Findl, MBA (Principal Investigator, Vienna Institute for Research in Ocular Surgery) — Sponsor-investigator
First posted
Nov 21, 2018
Start date
Jan 1, 2018
Primary completion
Jan 1, 2020 (estimated)
Completion
Jan 1, 2021 (estimated)
Last update
Feb 27, 2019

Study contacts

Stefan Palkovits, MD
Contact
office@viros.at
01 910 21-57573
Sahand Amir-Asgari, MD
Contact
office@viros.at
01 910 21-57557

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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