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

NCT ID: NCT00902109

Last Updated: 2016-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2016-12-31

Brief Summary

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

Detailed Description

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Conditions

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Primary Open Angle Glaucoma (POAG)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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perimetry, HRT, OCT

perimetry, HRT, OCT

Perimetry

Intervention Type DEVICE

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

Intervention Type DEVICE

HRT examinations for the clinical evaluation of the optic disc.

Optical Coherence Tomography (OCT)

Intervention Type DEVICE

imaging of the retinal nerve fiber layer

Interventions

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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

Intervention Type DEVICE

Confocal Scanning Laser Tomography

HRT examinations for the clinical evaluation of the optic disc.

Intervention Type DEVICE

Optical Coherence Tomography (OCT)

imaging of the retinal nerve fiber layer

Intervention Type DEVICE

Other Intervention Names

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Humphrey Field Analyzer 745i (HFA), Interzeag Octopus 101 Heidelberg Retina Tomograph (HRT) Spectralis-OCT (Heidelberg Engineering, Heidelberg, Germany)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Ulrich Schiefer

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ulrich Schiefer, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Locations

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Institute for Ophthalmic Research

Tübingen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 19060285 (View on PubMed)

Other Identifiers

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SCOPE-G-BETA

Identifier Type: -

Identifier Source: org_study_id

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