Non-arteritic Ischemic Optic NeuropathyPilot-SINNNCT01614158
Assessment of Visual Field-related Endpoints in Patients With Non-arteritic Ischemic Optic Neuropathy
An observational study of Non-arteritic Ischemic Optic Neuropathy, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
This present research project intends to collect five quantitative test series: perimetric examination using static stimuli, assessing the entire (80 degree) visual field with a fast thresholding algorithm (GATE) [Schiefer 2008] to know the extent/ magnitude of the visual field defect and its variability within the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-arteritic Ischemic Optic Neuropathy
- What is being tested?
- perimetry, D-BCVA and RAPD
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to Feb 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute N-AION (less then 7 days); male and female > 18 years
Who may be able to join
None listed.
Who cannot join
- diabetic retinopathy and any other orbital, intracranial or optic nerve disease
- history of epilepsy or significant psychiatric disease
- medications known to affect visual field sensitivity
- infections (e.g. keratitis, conjunctivitis, uveitis)
- severe dry eyes
- miotic drug
Show all 15Show fewer
- amblyopia
- strabismus
- any ocular pathology, in either eye, that may interfere with the ability to obtain visual fields, disc imaging or accurate IOP readings
- cataract with relevant impairment of vision
- keratoconus
- intraocular surgery (except for uncomplicated cataract surgery) performed < 3 month prior to screening
- history or signs of any visual pathway affection other than N-AION
- history or presence of macular disease and / or macular edema
- ocular trauma
Trial locations and contacts
1 site in 1 country.
Germany1 site
Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen
Tübingen, Baden-Wurttemberg
About this study
Official title: Pilot SINN; Assessment of Visual Field (vf)-Related Endpoints in Patients With Non-arteritic Ischemic Optic Neuropathy (N-AION)
This present research project intends to collect five quantitative test series:
- perimetric examination using static stimuli, assessing the entire (80 degree) visual field with a fast thresholding algorithm (GATE) [Schiefer 2008] to know the extent/ magnitude of the visual field defect and its variability within the cohort and over time
- D-BCVA, using FrACT [Bach 2007] and EDTRS chart [Ferris 1982]
- RAPD (using swinging flashlight test).
- IOP (using applanation tonometer)
- RNFT and RNFV using Spectralis OCT (star scan, ring scan 2,8 mm, and volume scan) Optic disk morphology will be documented by fundus photography. This assessment of the above-mentioned data is needed in order to allow for estimation of the spontaneous course / fluctuation of the (quantified) functional and morphometric parameters of the N-AION patients during the follow-up period. This is essential for the estimation of the sample size of the subsequently intended SINN study, that is intended to compare different therapeutic strategies in N-AION patients.
- Conditions
- Non-arteritic Ischemic Optic Neuropathy
- Being tested
- perimetry, D-BCVA, RAPD, IOP, Spectralis OCT
- Keywords
- N-AION, perimetry, visual field loss, Mean Defect, Total Loss Volume, D-BCVA, RAPD, retinal nerve fibre thickness/volume, optic nerve head
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perimetryDevice
Also called Static Perimetry, Octopus 101, thresholding algorithm
perimetric examination using static stimuli, assessing the entire (80 degree) visual field with a fast thresholding algorithm (GATE) [Schiefer 2008] to know the extent/ magnitude of the visual field defect and its variability within the cohort and over time
D-BCVAOther
Also called Best Corrected Visual Acuity, EDTRS Chart
D-BCVA using EDTRS chart
RAPDOther
Also called SWIFT-Test
RAPD using swinging flashlight test
IOPDevice
Also called intraocular pressure
IOP using applanation tonometer
Spectralis OCTDevice
Also called RNFT, RNFV, volume scan, star scan, Spectralis OCT
RNFT and RNFV using Spectralis OCT (star scan, ring scan 2,8 mm and volume scan)
Fundus photographyOther
Optic disk morphology will be documented by fundus photography
| Study group | Role | What they receive |
|---|---|---|
| acute N-AION (< 7 d) | physical, intellectual and linguistic abilities, in order to understand the test requirements
* willingness to comply with the protocol (4 visits)
* 45 - 80 years, informed consent
* acute N-AION (< 7 d)
* D-BCVA > 0.1 (2/20)
* RAPD ≥ 0.3 logE steps (neutral density filters) Receives: Device: perimetry; Other: D-BCVA; Other: RAPD; Device: IOP; Device: Spectralis OCT; Other: Fundus photography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of visual field (VF)-related endpoints in patients with non-arteritic ischemic optic neuropathy (N-AION)
This present research project intends to collect five quantitative test series in order to allow the estimation of the spontaneous course / fluctuation of the (quantified) functional and morphometric parameters of the N-AION patients during the follow-up period. This is essential for the estimation of the sample size of the subsequently intended SINN study, that is intended to compare different therapeutic strategies in N-AION patients
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startApr 2009
- Primary completionFeb 2011
- Study completionFeb 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 Non-arteritic Ischemic Optic NeuropathyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Freiburg
- Responsible party
- Principal investigator, Ulrich Schiefer, University Hospital Tuebingen
- Investigators
- Ulrich Schiefer, Prof., Principal investigator, Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614158
- Sponsor's protocol ID
- 73/2009B02
- Acronym
- Pilot-SINN
- Status last verified
- May 2014
- First submitted
- 4 Jun 2012
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kernstock C, Beisse F, Wiethoff S, Mast A, Krapp E, Grund R, Dietzsch J, Lagreze W, Fischer D, Schiefer U. Assessment of functional and morphometric endpoints in patients with non-arteritic anterior ischemic optic neuropathy (NAION). Graefes Arch Clin Exp Ophthalmol. 2014 Mar;252(3):515-21. doi: 10.1007/s00417-014-2572-z. Epub 2014 Jan 31.
PubMed 24477537
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot SINN; Assessment of Visual Field (vf)-Related Endpoints in Patients With Non-arteritic Ischemic Optic Neuropathy (N-AION)
- ClinicalTrials.gov ID
- NCT01614158
- Acronym / sponsor ID
- Pilot-SINN / 73/2009B02
- Conditions
- Non-arteritic Ischemic Optic Neuropathy
- Keywords
- N-AION, perimetry, visual field loss, Mean Defect, Total Loss Volume, D-BCVA, RAPD, retinal nerve fibre thickness/volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- University Hospital Freiburg
- Study start
- Apr 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 7 Jun 2012 (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.
This present research project intends to collect five quantitative test series:
- perimetric examination using static stimuli, assessing the entire (80 degree) visual field with a fast thresholding algorithm (GATE) [Schiefer 2008] to know the extent/ magnitude of the visual field defect and its variability within the cohort and over time
- D-BCVA, using FrACT [Bach 2007] and EDTRS chart [Ferris 1982]
- RAPD (using swinging flashlight test).
- IOP (using applanation tonometer)
- RNFT and RNFV using Spectralis OCT (star scan, ring scan 2,8 mm, and volume scan) Optic disk morphology will be documented by fundus photography. This assessment of the above-mentioned data is needed in order to allow for estimation of the spontaneous course / fluctuation of the (quantified) functional and morphometric parameters of the N-AION patients during the follow-up period. This is essential for the estimation of the sample size of the subsequently intended SINN study, that is intended to compare different therapeutic strategies in N-AION patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute N-AION (< 7 d) | – | Device: perimetry, Other: D-BCVA, Other: RAPD, Device: IOP, Device: Spectralis OCT, Other: Fundus photographyphysical, intellectual and linguistic abilities, in order to understand the test requirements * willingness to comply with the protocol (4 visits) * 45 - 80 years, informed consent * acute N-AION (< 7 d) * D-BCVA > 0.1 (2/20) * RAPD ≥ 0.3 logE steps (neutral density filters) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute N-AION (less then 7 days); male and female > 18 years
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- diabetic retinopathy and any other orbital, intracranial or optic nerve disease
- history of epilepsy or significant psychiatric disease
- medications known to affect visual field sensitivity
- infections (e.g. keratitis, conjunctivitis, uveitis)
- severe dry eyes
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: Static Perimetry, Octopus 101, thresholding algorithmperimetric examination using static stimuli, assessing the entire (80 degree) visual field with a fast thresholding algorithm (GATE) [Schiefer 2008] to know the extent/ magnitude of the visual field defect and its variability within the cohort and over time | Device | acute N-AION (< 7 d) |
| D-BCVAAlso: Best Corrected Visual Acuity, EDTRS ChartD-BCVA using EDTRS chart | Other | acute N-AION (< 7 d) |
| RAPDAlso: SWIFT-TestRAPD using swinging flashlight test | Other | acute N-AION (< 7 d) |
| IOPAlso: intraocular pressureIOP using applanation tonometer | Device | acute N-AION (< 7 d) |
| Spectralis OCTAlso: RNFT, RNFV, volume scan, star scan, Spectralis OCTRNFT and RNFV using Spectralis OCT (star scan, ring scan 2,8 mm and volume scan) | Device | acute N-AION (< 7 d) |
| Fundus photographyOptic disk morphology will be documented by fundus photography | Other | acute N-AION (< 7 d) |
Primary outcome
Assessment of visual field (VF)-related endpoints in patients with non-arteritic ischemic optic neuropathy (N-AION)
Time frame: 2 years
This present research project intends to collect five quantitative test series in order to allow the estimation of the spontaneous course / fluctuation of the (quantified) functional and morphometric parameters of the N-AION patients during the follow-up period. This is essential for the estimation of the sample size of the subsequently intended SINN study, that is intended to compare different therapeutic strategies in N-AION patients
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 28 May 2014.
- Results publication: PubMed 24477537Kernstock C, Beisse F, Wiethoff S, Mast A, Krapp E, Grund R, Dietzsch J, Lagreze W, Fischer D, Schiefer U. Assessment of functional and morphometric endpoints in patients with non-arteritic anterior ischemic optic neuropathy (NAION). Graefes Arch Clin Exp Ophthalmol. 2014 Mar;252(3):515-21. doi: 10.1007/s00417-014-2572-z. Epub 2014 Jan 31.
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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. principal investigator
Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen
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 Non-arteritic Ischemic Optic Neuropathy, 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 0 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: finished, as of the sponsor's last update on 28 May 2014. 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?
Assessment of visual field (VF)-related endpoints in patients with non-arteritic ischemic optic neuropathy (N-AION) (time frame: 2 years). 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 NCT01614158, 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 28 May 2014.