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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)

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ClinicalTrials.gov Identifier: NCT00902109
Recruitment Status : Unknown
Verified January 2016 by Ulrich Schiefer, University Hospital Tuebingen.
Recruitment status was:  Active, not recruiting
First Posted : May 14, 2009
Last Update Posted : February 2, 2016
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Ulrich Schiefer, University Hospital Tuebingen

Brief Summary:
The purpose of this study is to compare the two psychophysical perimetric techniques regarding progression of the visual field.

Condition or disease Intervention/treatment
Primary Open Angle Glaucoma (POAG) Device: Perimetry Device: Confocal Scanning Laser Tomography Device: Optical Coherence Tomography (OCT)

Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : April 2010
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Group/Cohort Intervention/treatment
perimetry, HRT, OCT
perimetry, HRT, OCT
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)



Primary Outcome Measures :
  1. Comparison of rate of progression [ Time Frame: 36 month ]
    Perimetric measures every 3 month over 3 years



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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
University Eye Hospital
Criteria

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

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): NCT00902109


Locations
Germany
Institute for Ophthalmic Research
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Alcon Research
Investigators
Principal Investigator: Ulrich Schiefer, Prof. Dr. med. University Hospital Tuebingen

Publications:
Responsible Party: Ulrich Schiefer, Prof. Dr. med., University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT00902109     History of Changes
Other Study ID Numbers: SCOPE-G-BETA
First Posted: May 14, 2009    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: January 2016

Keywords provided by Ulrich Schiefer, University Hospital Tuebingen:
visual field
perimetry
progression
POAG
glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Scotoma
Ocular Hypertension
Eye Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms