NCT00902109

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2009

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 2, 2016

Status Verified

January 1, 2016

Enrollment Period

6.7 years

First QC Date

May 12, 2009

Last Update Submit

January 31, 2016

Conditions

Primary Open Angle Glaucoma (POAG)

Keywords

visual fieldperimetryprogressionPOAGglaucoma

Outcome Measures

Primary Outcomes (1)

  • Comparison of rate of progression

    Perimetric measures every 3 month over 3 years

    36 month

Study Arms (1)

perimetry, HRT, OCT

perimetry, HRT, OCT

Device: PerimetryDevice: Confocal Scanning Laser TomographyDevice: Optical Coherence Tomography (OCT)

Interventions

PerimetryDEVICE

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

Also known as: Humphrey Field Analyzer 745i (HFA), Interzeag Octopus 101
perimetry, HRT, OCT
Confocal Scanning Laser TomographyDEVICE

HRT examinations for the clinical evaluation of the optic disc.

Also known as: Heidelberg Retina Tomograph (HRT)
perimetry, HRT, OCT
Optical Coherence Tomography (OCT)DEVICE

imaging of the retinal nerve fiber layer

Also known as: Spectralis-OCT (Heidelberg Engineering, Heidelberg, Germany)
perimetry, HRT, OCT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

University Eye Hospital

You may qualify if:

  • primary open angle glaucoma (POAG)
  • spherical ametropia max. ± 8 dpt
  • cylindrical ametropia max. ± 3 dpt
  • distant visual acuity \> 10/20
  • pupil diameter \> 3 mm

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Ophthalmic Research

Tübingen, 72076, Germany

Location

Related Publications (1)

  • 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.

    PMID: 19060285BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-AngleDisease ProgressionGlaucoma

Interventions

Visual Field TestsTomography, Optical Coherence

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vision TestsDiagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosisTomography, OpticalOptical ImagingDiagnostic ImagingTomographyInvestigative Techniques

Study Officials

  • Ulrich Schiefer, Prof. Dr. med.

    University Hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

May 12, 2009

First Posted

May 14, 2009

Study Start

April 1, 2010

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 2, 2016

Record last verified: 2016-01

Locations

DE(1)