Visual Field DefectsValGATENCT01265628
Validation of the GATE Software
An observational study of Visual Field Defects, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Comparison of the differential luminance sensitivity (DLS) values at each test point Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Visual Field Defects
- What is being tested?
- perimetry
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2010to Aug 2011
- 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: selected from the eye hospital's database
Who may be able to join
- physical, intellectual and linguistic abilities, in order to understand the test requirements
- spherical ametropia max. ± 8 dpt, cylindrical ametropia max. ± 3 dpt
- distant visual acuity > 10/20
- isocoria, pupil diameter > 3 mm
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 18Show fewer
- acute ocular infections (e.g. keratitis, conjunctivitis, uveitis)
- severe dry eyes
- miotic drugs
- amblyopia
- squint
- nystagmus
- albinism
- keratoconus
- intraocular surgery (except for uncomplicated cataract surgery) performed < 3 month prior to screening
- history or presence of macular disease and / or macular edema
- relevant opacities of central refractive media (cornea, lens, vitreous body)
- ocular trauma
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: Validation of the GATE Software for Static Visual Field Examinations
Comparison of the differential luminance sensitivity (DLS) values at each test point
- Conditions
- Visual Field Defects
- Being tested
- perimetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perimetryProcedure or surgery
Also called Octopus 900
automated static perimetry with adapted GATE strategy
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma | Not described Receives: Procedure: perimetry | |
| Retinitis pigmentosa (RP) | Not described Receives: Procedure: perimetry | |
| Anterior Ischemic Optic Neuropathy (AION) | Not described Receives: Procedure: perimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of visual field data and comparison of the differential luminance sensitivity (DLS) values at each test point by applying two perimetric software versions.
each participant were examined 2 times at two seperate sessions within 14 days.
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionAug 2011
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 Visual Field DefectsStudies of the same condition, open and under way.
- 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 (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Haag-Streit AG
- Responsible party
- Principal investigator, Ulrich Schiefer, University Hospital Tuebingen
- Investigators
- Ulrich Schiefer, Prof.Dr.med., Principal investigator, University of Tuebingen, Centre for Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265628
- Sponsor's protocol ID
- HSC GATE Strategie
- Other IDs
- 161/2009BO2
- Acronym
- ValGATE
- Status last verified
- Jan 2012
- First submitted
- 22 Dec 2010
- Last updated
- 26 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Luithardt AF, Meisner C, Monhart M, Krapp E, Mast A, Schiefer U. Validation of a new static perimetric thresholding strategy (GATE). Br J Ophthalmol. 2015 Jan;99(1):11-5. doi: 10.1136/bjophthalmol-2013-304535. Epub 2014 Jul 22.
PubMed 25053761
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the GATE Software for Static Visual Field Examinations
- ClinicalTrials.gov ID
- NCT01265628
- Acronym / sponsor ID
- ValGATE / HSC GATE Strategie
- Conditions
- Visual Field Defects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Haag-Streit AG
- Study start
- Nov 2010
- Primary completion
- Aug 2011 (actual)
- First posted
- 23 Dec 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.
Comparison of the differential luminance sensitivity (DLS) values at each test point
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glaucoma | – | Procedure: perimetry |
| Retinitis pigmentosa (RP) | – | Procedure: perimetry |
| Anterior Ischemic Optic Neuropathy (AION) | – | Procedure: perimetry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- selected from the eye hospital's database
Key inclusion criteria (4 listed)
- physical, intellectual and linguistic abilities, in order to understand the test requirements
- spherical ametropia max. ± 8 dpt, cylindrical ametropia max. ± 3 dpt
- distant visual acuity > 10/20
- isocoria, pupil diameter > 3 mm
Key exclusion criteria (18 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 |
|---|---|---|
| perimetryAlso: Octopus 900automated static perimetry with adapted GATE strategy | Procedure or surgery | Anterior Ischemic Optic Neuropathy (AION), Glaucoma, Retinitis pigmentosa (RP) |
Primary outcome
Validation of visual field data and comparison of the differential luminance sensitivity (DLS) values at each test point by applying two perimetric software versions.
Time frame: up to 14 days
each participant were examined 2 times at two seperate sessions within 14 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
- Derived from this study: PubMed 25053761Luithardt AF, Meisner C, Monhart M, Krapp E, Mast A, Schiefer U. Validation of a new static perimetric thresholding strategy (GATE). Br J Ophthalmol. 2015 Jan;99(1):11-5. doi: 10.1136/bjophthalmol-2013-304535. Epub 2014 Jul 22.
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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 of Tuebingen, Centre for Ophthalmology
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 Visual Field Defects, 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 18 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: finished, as of the sponsor's last update on 26 Jan 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Validation of visual field data and comparison of the differential luminance sensitivity (DLS) values at each test point by applying two perimetric software versions. (time frame: up to 14 days). 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 NCT01265628, 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 26 Jan 2012.