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Study to Compare Standard Perimetry With the New Scotoma-Oriented Perimetry (SCOPE) Using a New Fast German Adaptive Threshold Estimation (GATE) in Glaucoma Patients (TRASCO)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00902109
First Posted: May 14, 2009
Last Update Posted: February 2, 2016
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:
Alcon Research
Information provided by (Responsible Party):
Ulrich Schiefer, University Hospital Tuebingen
May 12, 2009
May 14, 2009
February 2, 2016
April 2010
December 2016   (Final data collection date for primary outcome measure)
Comparison of rate of progression [ Time Frame: 36 month ]
Perimetric measures every 3 month over 3 years
Not Provided
Complete list of historical versions of study NCT00902109 on ClinicalTrials.gov Archive Site
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Study to Compare Standard Perimetry With the New Scotoma-Oriented Perimetry (SCOPE) Using a New Fast German Adaptive Threshold Estimation (GATE) in Glaucoma Patients
Pilot Study to Compare the Humphrey Field Analyzer (HFA) 30-2 Swedish Interactive Threshold Algorithm (SITA) Standard Perimetry With the New Scotoma-Oriented Perimetry (SCOPE), Using a New Fast GATE (German Adaptive Threshold Estimation) in Glaucoma Patients Under Topic Therapy
The purpose of this study is to compare the two psychophysical perimetric techniques regarding progression of the visual field.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
University Eye Hospital
Primary Open Angle Glaucoma (POAG)
  • Device: Perimetry
    different perimetric devices, different perimetric grids: Octopus: New Scotoma-Oriented Perimetry (SCOPE) Using a New Fast German Adaptive Threshold Estimation (GATE) HFA: 30-2, Sita (Swedish Interactive Thresholding Algorithm) full threshold
    Other Name: Humphrey Field Analyzer 745i (HFA), Interzeag Octopus 101
  • Device: Confocal Scanning Laser Tomography
    HRT examinations for the clinical evaluation of the optic disc.
    Other Name: Heidelberg Retina Tomograph (HRT)
  • Device: Optical Coherence Tomography (OCT)
    imaging of the retinal nerve fiber layer
    Other Name: Spectralis-OCT (Heidelberg Engineering, Heidelberg, Germany)
perimetry, HRT, OCT
perimetry, HRT, OCT
Interventions:
  • Device: Perimetry
  • Device: Confocal Scanning Laser Tomography
  • Device: Optical Coherence Tomography (OCT)
Schiefer U, Pascual JP, Edmunds B, Feudner E, Hoffmann EM, Johnson CA, Lagrèze WA, Pfeiffer N, Sample PA, Staubach F, Weleber RG, Vonthein R, Krapp E, Paetzold J. Comparison of the new perimetric GATE strategy with conventional full-threshold and SITA standard strategies. Invest Ophthalmol Vis Sci. 2009 Jan;50(1):488-94. doi: 10.1167/iovs.08-2229. Epub 2008 Dec 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
12
December 2016
December 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • primary open angle glaucoma (POAG)
  • spherical ametropia max. ± 8 dpt
  • cylindrical ametropia max. ± 3 dpt
  • distant visual acuity > 10/20
  • pupil diameter > 3 mm

Exclusion Criteria:

  • diabetic retinopathy
  • asthma
  • history of epilepsy or significant psychiatric disease
  • medications known to effect visual field sensitivity
  • infections (e.g., keratitis, conjunctivitis, uveitis)
  • severe dry eyes
  • miotic drug
  • squint
  • nystagmus
  • albinism
  • any ocular pathology, in either eye, that may interfere with the ability to obtain visual fields
  • keratoconus
  • intraocular surgery (except for uncomplicated cataract surgery) performed < 3 month prior to screening
  • history or signs of any visual pathway affection other than glaucoma
  • history or presence of macular disease and/or macular edema, ocular trauma, medications known to affect visual field sensitivity
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00902109
SCOPE-G-BETA
No
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Ulrich Schiefer, University Hospital Tuebingen
University Hospital Tuebingen
Alcon Research
Principal Investigator: Ulrich Schiefer, Prof. Dr. med. University Hospital Tuebingen
University Hospital Tuebingen
January 2016