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

Sponsor
University Hospital Tuebingen (Other)
Overall Status
Unknown status
CT.gov ID
NCT00902109
Collaborator
Alcon Research (Industry)
12
Enrollment
1
Location
80
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Device: Perimetry
  • Device: Confocal Scanning Laser Tomography
  • Device: Optical Coherence Tomography (OCT)

Study Design

Study Type:
Observational
Anticipated 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 :
Apr 1, 2010
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm 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 Names:
  • Humphrey Field Analyzer 745i (HFA), Interzeag Octopus 101

    • Device: Confocal Scanning Laser Tomography
    HRT examinations for the clinical evaluation of the optic disc.
    Other Names:
  • Heidelberg Retina Tomograph (HRT)

    • Device: Optical Coherence Tomography (OCT)
    imaging of the retinal nerve fiber layer
    Other Names:
  • Spectralis-OCT (Heidelberg Engineering, Heidelberg, Germany)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of rate of progression [36 month]

      Perimetric measures every 3 month over 3 years

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ulrich Schiefer, Prof. Dr. med., University Hospital Tuebingen
    ClinicalTrials.gov Identifier:
    NCT00902109
    Other Study ID Numbers:
    • SCOPE-G-BETA
    First Posted:
    May 14, 2009
    Last Update Posted:
    Feb 2, 2016
    Last Verified:
    Jan 1, 2016
    Keywords provided by Ulrich Schiefer, Prof. Dr. med., University Hospital Tuebingen
    visual field
    perimetry
    progression
    POAG
    glaucoma
    Additional relevant MeSH terms:
    Scotoma
    Glaucoma
    Glaucoma, Open-Angle

    Study Results

    No Results Posted as of Feb 2, 2016