Validation of the GATE Software (ValGATE)

This study has been completed.
Sponsor:
Collaborator:
Haag-Streit AG
Information provided by (Responsible Party):
Ulrich Schiefer, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01265628
First received: December 22, 2010
Last updated: January 25, 2012
Last verified: January 2012
  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 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 22, 2010
Last Updated: January 25, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Scotoma
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 23, 2014