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

Glaucoma Clinical Trial

— X-SCOPE  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01068938
• Other study ID #: X-SCOPE
• Secondary ID: 116MIR08023428/2
• Status: Active, not recruiting
• Phase: N/A
• First received: February 16, 2010
• Last updated: December 19, 2016
• Start date: November 2008
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• three different perimeters: HFA, Octopus, MATRIX
visual fields

Locations

Country	Name	City	State
Germany	Centre for Ophthalmology, Institute for Ophthalmic Research	Tuebingen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Pfizer

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glaucoma progression		6 month	No

External Links

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