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)

January 31, 2016 updated by: Ulrich Schiefer, University Hospital Tuebingen

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tuebingen, Germany, 72076
        • Institute for Ophthalmic Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

University Eye Hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of rate of progression
Time Frame: 36 month
Perimetric measures every 3 month over 3 years
36 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Collaborators

Alcon Research

Investigators

  • Principal Investigator: Ulrich Schiefer, Prof. Dr. med., University Hospital Tuebingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

May 12, 2009

First Submitted That Met QC Criteria

May 12, 2009

First Posted (Estimate)

May 14, 2009

Study Record Updates

Last Update Posted (Estimate)

February 2, 2016

Last Update Submitted That Met QC Criteria

January 31, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCOPE-G-BETA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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