Validation of the GATE Software (ValGATE)

January 25, 2012 updated by: Ulrich Schiefer, University Hospital Tuebingen

Validation of the GATE Software for Static Visual Field Examinations

Comparison of the differential luminance sensitivity (DLS) values at each test point

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tuebingen, Germany, 72076
        • Centre for Ophthalmology, Institute for Ophthalmic Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

selected from the eye hospital's database

Description

Inclusion Criteria:

  • physical, intellectual and linguistic abilities, in order to understand the test requirements
  • spherical ametropia max. ± 8 dpt, cylindrical ametropia max. ± 3 dpt
  • distant visual acuity > 10/20
  • isocoria, pupil diameter > 3 mm

Exclusion Criteria:

  • pregnancy, nursing
  • diabetic retinopathy
  • asthma
  • HIV+ or AIDS
  • history of epilepsy or significant psychiatric disease
  • medications known to effect visual field sensitivity
  • acute ocular infections (e.g. keratitis, conjunctivitis, uveitis)
  • severe dry eyes
  • miotic drugs
  • amblyopia
  • squint
  • nystagmus
  • albinism
  • keratoconus
  • intraocular surgery (except for uncomplicated cataract surgery) performed < 3 month prior to screening
  • history or presence of macular disease and / or macular edema
  • relevant opacities of central refractive media (cornea, lens, vitreous body)
  • ocular trauma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Glaucoma
Procedure: perimetry
automated static perimetry with adapted GATE strategy
Other Names:
  • Octopus 900
Retinitis pigmentosa (RP)
Procedure: perimetry
automated static perimetry with adapted GATE strategy
Other Names:
  • Octopus 900
Anterior Ischemic Optic Neuropathy (AION)
Procedure: perimetry
automated static perimetry with adapted GATE strategy
Other Names:
  • Octopus 900

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of visual field data and comparison of the differential luminance sensitivity (DLS) values at each test point by applying two perimetric software versions.
Time Frame: up to 14 days
each participant were examined 2 times at two seperate sessions within 14 days.
up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Collaborators

Haag-Streit AG

Investigators

  • Principal Investigator: Ulrich Schiefer, Prof.Dr.med., University of Tuebingen, Centre for Ophthalmology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

December 22, 2010

First Submitted That Met QC Criteria

December 22, 2010

First Posted (Estimate)

December 23, 2010

Study Record Updates

Last Update Posted (Estimate)

January 26, 2012

Last Update Submitted That Met QC Criteria

January 25, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • HSC GATE Strategie
  • 161/2009BO2 (Other Identifier: Ethics Committee University Hospital Tübingen)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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