NCT03750149

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

2 years

First QC Date

November 20, 2018

Last Update Submit

February 26, 2019

Conditions

Diabetic MaculopathyAge Related Macular DegenerationGlaucomaEpiretinal Membrane

Keywords

Diabetic MaculopathyAge Related Macular DegenerationGlaucomaEpiretinal membraneReading analysis

Outcome Measures

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.

    12 months

Secondary Outcomes (1)

  • Retinal perimetry

    12 months

Study Arms (1)

Ophthalmologic Disease

EXPERIMENTAL

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

Device: EyeTracker

Interventions

EyeTrackerDEVICE

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

Ophthalmologic Disease

Eligibility Criteria

Age21 Years - 105 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Ocular pathologies, that may interfere with study measurements, such as corneal scars

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, 1140, Austria

RECRUITING

MeSH Terms

Conditions

Macular DegenerationGlaucomaEpiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesOcular Hypertension

Central Study Contacts

Stefan Palkovits, MD

CONTACT

01 910 21-57573office@viros.at

Sahand Amir-Asgari, MD

CONTACT

01 910 21-57557office@viros.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2018

First Posted

November 21, 2018

Study Start

January 1, 2018

Primary Completion

January 1, 2020

Study Completion

January 1, 2021

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

AU(1)