Primary Open Angle Glaucoma (POAG)TRASCONCT00902109
Study to Compare Standard Perimetry With the New Scotoma-Oriented Perimetry (SCOPE) Using a New Fast German Adaptive Threshold Estimation (GATE) in Glaucoma Patients
An observational study of Primary Open Angle Glaucoma (POAG), run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The purpose of this study is to compare the two psychophysical perimetric techniques regarding progression of the visual field. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma (POAG)
- What is being tested?
- Perimetry, Confocal Scanning Laser Tomography and Optical Coherence Tomography (OCT)
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: University Eye Hospital
Who may be able to join
- primary open angle glaucoma (POAG)
- spherical ametropia max. ± 8 dpt
- cylindrical ametropia max. ± 3 dpt
- distant visual acuity > 10/20
- pupil diameter > 3 mm
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is to compare the two psychophysical perimetric techniques regarding progression of the visual field.
- Conditions
- Primary Open Angle Glaucoma (POAG)
- Being tested
- Perimetry, Confocal Scanning Laser Tomography, Optical Coherence Tomography (OCT)
- Keywords
- visual field, perimetry, progression, POAG, glaucoma
- Medical subject headings
- Glaucoma, Open-Angle, Disease Progression, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerimetryDevice
Also called Humphrey Field Analyzer 745i (HFA), Interzeag Octopus 101
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 TomographyDevice
Also called Heidelberg Retina Tomograph (HRT)
HRT examinations for the clinical evaluation of the optic disc.
Optical Coherence Tomography (OCT)Device
Also called Spectralis-OCT (Heidelberg Engineering, Heidelberg, Germany)
imaging of the retinal nerve fiber layer
| Study group | Role | What they receive |
|---|---|---|
| perimetry, HRT, OCT | perimetry, HRT, OCT Receives: Device: Perimetry; Device: Confocal Scanning Laser Tomography; Device: Optical Coherence Tomography (OCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of rate of progression
Perimetric measures every 3 month over 3 years
Measured: 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startApr 2010
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Open Angle Glaucoma (POAG)Studies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Ulrich Schiefer, University Hospital Tuebingen
- Investigators
- Ulrich Schiefer, Prof. Dr. med., Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902109
- Sponsor's protocol ID
- SCOPE-G-BETA
- Acronym
- TRASCO
- Status last verified
- Jan 2016
- First submitted
- 12 May 2009
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19060285
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00902109
- Acronym / sponsor ID
- TRASCO / SCOPE-G-BETA
- Conditions
- Primary Open Angle Glaucoma (POAG)
- Keywords
- visual field, perimetry, progression, POAG, glaucoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Apr 2010
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 14 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the two psychophysical perimetric techniques regarding progression of the visual field.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| perimetry, HRT, OCT | – | Device: Perimetry, Device: Confocal Scanning Laser Tomography, Device: Optical Coherence Tomography (OCT)perimetry, HRT, OCT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University Eye Hospital
Key inclusion criteria (5 listed)
- primary open angle glaucoma (POAG)
- spherical ametropia max. ± 8 dpt
- cylindrical ametropia max. ± 3 dpt
- distant visual acuity > 10/20
- pupil diameter > 3 mm
Key exclusion criteria (15 listed)
- diabetic retinopathy
- asthma
- history of epilepsy or significant psychiatric disease
- medications known to effect visual field sensitivity
- infections (e.g., keratitis, conjunctivitis, uveitis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PerimetryAlso: Humphrey Field Analyzer 745i (HFA), Interzeag Octopus 101different 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 | Device | perimetry, HRT, OCT |
| Confocal Scanning Laser TomographyAlso: Heidelberg Retina Tomograph (HRT)HRT examinations for the clinical evaluation of the optic disc. | Device | perimetry, HRT, OCT |
| Optical Coherence Tomography (OCT)Also: Spectralis-OCT (Heidelberg Engineering, Heidelberg, Germany)imaging of the retinal nerve fiber layer | Device | perimetry, HRT, OCT |
Primary outcome
Comparison of rate of progression
Time frame: 36 month
Perimetric measures every 3 month over 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
- Background: PubMed 19060285Schiefer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Schiefer, Prof. Dr. med. principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Open Angle Glaucoma (POAG), run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of rate of progression (time frame: 36 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00902109, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2016.