GlaucomaX-SCOPENCT01068938
Comparison of Visual Fields: Humphrey Field Analyzer (HFA) SITA Strategy, SCOPE (GATE Strategy) and Humphrey MATRIX Perimeter
An observational study of Glaucoma, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The purpose of this study is to compare three perimetric techniques regarding progression of the visual field. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- three different perimeters: HFA, Octopus, MATRIX
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2008to 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: University Eye Hospital
Who may be able to join
- 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
Who cannot join
- pregnancy, nursing
- diabetic retinopathy
- asthma
- HIV+ or AIDS
- history of epilepsy or significant psychiatric disease
- medications known to effect visual field sensitivity
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Centre for Ophthalmology, Institute for Ophthalmic Research
Tübingen, 72076
About this study
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)
The purpose of this study is to compare three perimetric techniques regarding progression of the visual field.
- Conditions
- Glaucoma
- Being tested
- three different perimeters: HFA, Octopus, MATRIX
- Keywords
- visual field, perimetry, glaucoma progression, grid, POAG and glaucoma suspects with prostaglandin monotherapy
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
three different perimeters: HFA, Octopus, MATRIXDevice
visual fields
| Study group | Role | What they receive |
|---|---|---|
| open angle glaucoma, glaucoma suspects | risk of progression, Latanoprost monotherapy Receives: Device: three different perimeters: HFA, Octopus, MATRIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
glaucoma progression
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startNov 2008
- Primary completionDec 2013
- 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 GlaucomaStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Ulrich Schiefer, University Hospital Tuebingen
- Investigators
- Ulrich Schiefer, MD, Principal investigator, Centre for Ophthalmology, Institute for Ophthalmic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068938
- Sponsor's protocol ID
- X-SCOPE
- Other IDs
- 116MIR08023, 428/2008BO1
- Acronym
- X-SCOPE
- Status last verified
- Dec 2016
- First submitted
- 16 Feb 2010
- Last updated
- 20 Dec 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 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01068938
- Acronym / sponsor ID
- X-SCOPE / X-SCOPE
- Conditions
- Glaucoma
- Keywords
- visual field, perimetry, glaucoma progression, grid, POAG and glaucoma suspects with prostaglandin monotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Nov 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 17 Feb 2010 (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 three perimetric techniques regarding progression of the visual field.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open angle glaucoma, glaucoma suspects | – | Device: three different perimeters: HFA, Octopus, MATRIXrisk of progression, Latanoprost monotherapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University Eye Hospital
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- pregnancy, nursing
- diabetic retinopathy
- asthma
- HIV+ or AIDS
- history of epilepsy or significant psychiatric disease
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 |
|---|---|---|
| three different perimeters: HFA, Octopus, MATRIXvisual fields | Device | open angle glaucoma, glaucoma suspects |
Primary outcome
glaucoma progression
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 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, MD principal investigator
Centre for Ophthalmology, Institute for Ophthalmic Research
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 Glaucoma, 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 4 inclusion and 21 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 20 Dec 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?
glaucoma progression (time frame: 6 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 NCT01068938, 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 20 Dec 2016.