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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Ulrich Schiefer, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01068938
First received: February 16, 2010
Last updated: December 10, 2013
Last verified: December 2013
  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:


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 2014
Primary Completion Date: December 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068938

Locations
Germany
Centre for Ophthalmology, Institute for Ophthalmic Research
Tuebingen, Germany, 72076
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: Ulrich Schiefer, Prof. Dr. med., University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01068938     History of Changes
Other Study ID Numbers: X-SCOPE, 116MIR08023, 428/2008BO1
Study First Received: February 16, 2010
Last Updated: December 10, 2013
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 September 18, 2014