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Validation of the GATE Software (ValGATE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01265628
First Posted: December 23, 2010
Last Update Posted: January 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Haag-Streit AG
Information provided by (Responsible Party):
Ulrich Schiefer, University Hospital Tuebingen
  Purpose
Comparison of the differential luminance sensitivity (DLS) values at each test point

Condition Intervention
Visual Field Defects Procedure: perimetry

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of the GATE Software for Static Visual Field Examinations

Further study details as provided by Ulrich Schiefer, University Hospital Tuebingen:

Primary Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: November 2010
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Glaucoma Procedure: perimetry
automated static perimetry with adapted GATE strategy
Other Name: Octopus 900
Retinitis pigmentosa (RP) Procedure: perimetry
automated static perimetry with adapted GATE strategy
Other Name: Octopus 900
Anterior Ischemic Optic Neuropathy (AION) Procedure: perimetry
automated static perimetry with adapted GATE strategy
Other Name: Octopus 900

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
selected from the eye hospital's database
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265628


Locations
Germany
Centre for Ophthalmology, Institute for Ophthalmic Research
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Haag-Streit AG
Investigators
Principal Investigator: Ulrich Schiefer, Prof.Dr.med. University of Tuebingen, Centre for Ophthalmology
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ulrich Schiefer, Prof. Dr. med. Ulrich Schiefer, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01265628     History of Changes
Other Study ID Numbers: HSC GATE Strategie
161/2009BO2 ( Other Identifier: Ethics Committee University Hospital Tübingen )
First Submitted: December 22, 2010
First Posted: December 23, 2010
Last Update Posted: January 26, 2012
Last Verified: January 2012