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Clinical Trials/NCT01265628
NCT01265628CompletedNot Applicable

Validation of the GATE Software for Static Visual Field Examinations

University Hospital Tuebingen1 site in 1 country30 target enrollmentStarted: November 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Validation of visual field data and comparison of the differential luminance sensitivity (DLS) values at each test point by applying two perimetric software versions.

Study Overview

Brief Summary

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • 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
  • nystagmus
  • 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ulrich Schiefer

Prof. Dr. med. Ulrich Schiefer

University Hospital Tuebingen

Study Sites (1)

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