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Trial record 1 of 1 for:    NCT01068938
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Comparison of Visual Fields: Humphrey Field Analyzer (HFA) SITA Strategy, SCOPE (GATE Strategy) and Humphrey MATRIX Perimeter (X-SCOPE)

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ClinicalTrials.gov Identifier: NCT01068938
Recruitment Status : Unknown
Verified December 2016 by Ulrich Schiefer, University Hospital Tuebingen.
Recruitment status was:  Active, not recruiting
First Posted : February 17, 2010
Last Update Posted : December 20, 2016
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Ulrich Schiefer, University Hospital Tuebingen

Tracking Information
First Submitted Date February 16, 2010
First Posted Date February 17, 2010
Last Update Posted Date December 20, 2016
Study Start Date November 2008
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 11, 2011)
glaucoma progression [ Time Frame: 6 month ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison of Visual Fields: Humphrey Field Analyzer (HFA) SITA Strategy, SCOPE (GATE Strategy) and Humphrey MATRIX Perimeter
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)
Brief Summary The purpose of this study is to compare three perimetric techniques regarding progression of the visual field.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population University Eye Hospital
Condition Glaucoma
Intervention Device: three different perimeters: HFA, Octopus, MATRIX
visual fields
Study Groups/Cohorts open angle glaucoma, glaucoma suspects
risk of progression, Latanoprost monotherapy
Intervention: Device: three different perimeters: HFA, Octopus, MATRIX
Publications * Schiefer U, Pascual JP, Edmunds B, Feudner E, Hoffmann EM, Johnson CA, Lagrèze WA, Pfeiffer N, Sample PA, Staubach F, Weleber RG, Vonthein R, Krapp E, Paetzold J. Comparison of the new perimetric GATE strategy with conventional full-threshold and SITA standard strategies. Invest Ophthalmol Vis Sci. 2009 Jan;50(1):488-94. doi: 10.1167/iovs.08-2229. Epub 2008 Dec 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 16, 2010)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2016
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01068938
Other Study ID Numbers X-SCOPE
116MIR08023 ( Other Grant/Funding Number: Pfizer )
428/2008BO1 ( Other Identifier: Ethics Committee University Hospital Tübingen )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ulrich Schiefer, University Hospital Tuebingen
Study Sponsor University Hospital Tuebingen
Collaborators Pfizer
Investigators
Principal Investigator: Ulrich Schiefer, MD Centre for Ophthalmology, Institute for Ophthalmic Research
PRS Account University Hospital Tuebingen
Verification Date December 2016