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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Eye Diseases
Nervous System Diseases
Neurologic Manifestations
Sensation Disorders
Signs and Symptoms
Vision Disorders

ClinicalTrials.gov processed this record on October 29, 2014