Clinical trial NCT01068938: 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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Keywords: visual field
perimetry
glaucoma progression
grid
POAG and glaucoma suspects with prostaglandin monotherapy
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2010-02-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: University Eye Hospital

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


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

Primary outcomes:
measure: glaucoma progression
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Centre for Ophthalmology, Institute for Ophthalmic Research
Study officials:
affiliation: Centre for Ophthalmology, Institute for Ophthalmic Research
name: Ulrich Schiefer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schiefer U, Pascual JP, Edmunds B, Feudner E, Hoffmann EM, Johnson CA, Lagreze 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.