Study to Compare Standard Perimetry With the New Scotoma-Oriented Perimetry (SCOPE) Using a New Fast German Adaptive Threshold Estimation (GATE) in Glaucoma Patients

Primary Open Angle Glaucoma (POAG) Clinical Trial

— TRASCO  

Official title:

Pilot Study to Compare the Humphrey Field Analyzer (HFA) 30-2 Swedish Interactive Threshold Algorithm (SITA) Standard Perimetry With the New Scotoma-Oriented Perimetry (SCOPE), Using a New Fast GATE (German Adaptive Threshold Estimation) in Glaucoma Patients Under Topic Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00902109
• Other study ID #: SCOPE-G-BETA
• Status: Active, not recruiting
• Phase: N/A
• First received: May 12, 2009
• Last updated: January 31, 2016
• Start date: April 2010
• Est. completion date: December 2016

Study information

• Verified date: January 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 the two psychophysical perimetric techniques regarding progression of the visual field.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• primary open angle glaucoma (POAG)

• spherical ametropia max. ± 8 dpt

• cylindrical ametropia max. ± 3 dpt

• distant visual acuity > 10/20

• pupil diameter > 3 mm

Exclusion Criteria:

• diabetic retinopathy

• asthma

• 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

• squint

• nystagmus

• albinism

• any ocular pathology, in either eye, that may interfere with the ability to obtain visual fields

• 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

• 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
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma (POAG)

Intervention

Device:
• Perimetry
different perimetric devices, different perimetric grids: Octopus: New Scotoma-Oriented Perimetry (SCOPE) Using a New Fast German Adaptive Threshold Estimation (GATE) HFA: 30-2, Sita (Swedish Interactive Thresholding Algorithm) full threshold
• Confocal Scanning Laser Tomography
HRT examinations for the clinical evaluation of the optic disc.
• Optical Coherence Tomography (OCT)
imaging of the retinal nerve fiber layer

Locations

Country	Name	City	State
Germany	Institute for Ophthalmic Research	Tuebingen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Alcon Research

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. Epub 2008 Dec 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of rate of progression	Perimetric measures every 3 month over 3 years	36 month	No