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Comparison of Visual Fields: Humphrey Field Analyzer (HFA) SITA Strategy, SCOPE (GATE Strategy) and Humphrey MATRIX Perimeter (X-SCOPE)

This study is currently recruiting participants.
Verified December 2010 by University Hospital Tuebingen
Sponsor:
Collaborator:
Pfizer
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01068938
First received: February 16, 2010
Last updated: February 11, 2011
Last verified: December 2010
History of Changes
  Purpose

The purpose of this study is to compare three perimetric techniques regarding progression of the visual field.


Condition Intervention
Glaucoma
 Device: three different perimeters: HFA, Octopus, MATRIX

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Visual Field Defects and Scotoma Progression in Glaucomatous Optic Neuropathy, Using Short-term Intervals With Automated Scotoma-oriented Perimetry (SCOPE) and the Fast Thresholding Strategy GATE (German Adaptive Threshold Estimation)

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • glaucoma progression [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
open angle glaucoma, glaucoma suspects
risk of progression, Latanoprost monotherapy
 Device: three different perimeters: HFA, Octopus, MATRIX
visual fields

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

University Eye Hospital

Criteria

Inclusion Criteria:

  • max. ± 8 dpt sph, max. ± 3 dpt cyl
  • distant visual acuity > 10/20
  • isocoria, pupil diameter > 3 mm
  • at least one risk of progression: optic disc (splinter) hemorrhage / cup to disc ratio (CDR) > 0.7 / inter-eye asymmetry of CDR >0.2 / notching of the optic disc /retinal nerve fibre layer (RNFL) defects / intraocular pressure( IOP) >22 mmHg / central corneal thickness < 520 µm / advanced visual field defect stage Aulhorn III / elder than 70 years

Exclusion Criteria:

  • pregnancy, nursing
  • diabetic retinopathy
  • asthma
  • HIV+ or AIDS
  • 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
  • amblyopia
  • squint
  • nystagmus
  • albinism
  • any ocular pathology, in either eye, that may interfere with the ability to obtain visual fields,disc imaging or accurate IOP readings
  • 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
  • allergies with regard to topic glaucoma medication
  • history or presence of macular disease and / or macular edema
  • ocular trauma
  • medications known to affect visual field sensitivity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01068938

Contacts
Contact: Elke Krapp +49 707129 ext 80726 elke.krapp@med.uni-tuebingen.de

Locations
Germany
Centre for Ophthalmology, Institute for Ophthalmic Research Recruiting
Tuebingen, Germany, 72076
Contact: Elke Krapp     +49 707129 ext 80726     elke.krapp@med.uni-tuebingen.de    
Principal Investigator: Ulrich Schiefer, MD            
Sponsors and Collaborators
University Hospital Tuebingen
Pfizer
Investigators
Principal Investigator: Ulrich Schiefer, MD Centre for Ophthalmology, Institute for Ophthalmic Research
  More Information

Publications:

Responsible Party: Prof. Dr. med. Ulrich Schiefer, Centre for Ophthalmology, Institute for Ophthalmic Research
ClinicalTrials.gov Identifier: NCT01068938     History of Changes
Other Study ID Numbers: X-SCOPE, 116MIR08023, 428/2008BO1
Study First Received: February 16, 2010
Last Updated: February 11, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Tuebingen:
visual field
perimetry
glaucoma progression
grid
POAG and glaucoma suspects with prostaglandin monotherapy

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013