Neuropathy, OpticNOIANCT03642899
OCT Angiography in Arteritic and Non Arteritic Anterior Ischemic Neuropathy
An observational study of Neuropathy, Optic, run by Poitiers University Hospital at 1 site in France.
Trial summary
Anterior ischaemic optic neuropathy results from infarction of retrolaminar portion of the optic nerve head, caused by occlusion of the posterior ciliary artery. Non arteritic anterior ischaemic optic neuropathy affects more frequently people between 50 and 70 years of age, with vasculopathic risk factors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuropathy, Optic
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 29 Aug 2018to 4 Jun 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Patients with arteritic or non-arteritic anterior ischemic optic neuropathy ,> 3 months or after disappearance of papillary edema * Control subjects, with normal optic nerve and symmetrical appearance
Who may be able to join
- Patients with arteritic or non-arteritic anterior ischemic optic neuropathy ,> 3 months or after disappearance of papillary edema
- Control subjects, with normal optic nerve and symmetrical appearance , without diagnosed glaucoma (intraocular tension lower than 21mmHg) and without antecedent of retinal or intraorbital pathology.
- Patient with cataract can be included, within the limits of the good acquisition of images.
- Free, without tutorship or curatorship or subordination
- Benefiting from a Social Security scheme or benefiting through a third party
- Giving their non-opposition, after clear and fair information on the study
Who cannot join
- with ocular or retinal pathology leading to irreversible visual impairment or macular involvement (strong myopia> 6 diopters, astigmatism> 3 diopters, retinitis pigmentosa, occlusion of the central artery of the retina or central vein of the retina , CRSC, diabetic retinopathy), or history of ocular or retinal surgery except cataract surgery.
- having an alteration of the optic nerve related to another pathology (NORB, glaucoma evolved with cup / disc> 0.7 or poorly balanced tension, optic neuritis),
- performing the exam impossible or poor image quality
- impossibility of giving one's non-opposition,
- not benefiting from a social security scheme or benefiting from it through a third person
- benefiting from enhanced protection, namely: minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Peripapillary Vasculature With OCT-angiography in Arteritic and Non Arteritic Anterior Ischemic Neuropathy After Oedema Disappearance
Anterior ischaemic optic neuropathy results from infarction of retrolaminar portion of the optic nerve head, caused by occlusion of the posterior ciliary artery. Non arteritic anterior ischaemic optic neuropathy affects more frequently people between 50 and 70 years of age, with vasculopathic risk factors. Arteritic anterior ischaemic optic neuropathy is caused by the Horton disease, affects an older population and is an ophthalmologic emergency because of the bilateralisation's risk.
The aim of this study is to compare the peripapillar vascular density of anterior ischaemic optic neuropathy eyes (arteritic and non arteritic) with normal eyes after the disappearance of the papillar edema, with oCT-angiography.
Read more
The investigators will include patients with anterior ischaemic optic neuropathy and normal patients. For each participant, the investigators will estimate the best visual acuity, intra-ocular pressure, make a fondus, measurement of retinal nervous layer thickness, ganglionar cells layer thickness, and a macular and papillar OCT angiography during a consultation (duration 30 min).
The investigators will be able to know if
- there is a modification of the peripapillary vascularisation subsequent to the occlusion of the posterior ciliary artery
- there is a difference between arteritic and non arteritic anterior ischaemic optic neuropathy,
- there is a repercussion of the neuropathy on the retinal layers,
- there is a difference in peripapillar vascularisation by age.
Read the detailed description
Anterior ischaemic optic neuropathy results from infarction of retrolaminar portion of the optic nerve head, caused by occlusion of the posterior ciliary artery. Non arteritic anterior ischaemic optic neuropathy affects more frequently people between 50 and 70 years of age, with vasculopathic risk factors. Arteritic anterior ischaemic optic neuropathy is caused by the Horton disease, affects an older population and is an ophthalmologic emergency because of the bilateralisation's risk.
The aim of this study is to compare the peripapillar vascular density of anterior ischaemic optic neuropathy eyes (arteritic and non arteritic) with normal eyes after the disappearance of the papillar edema, with oCT-angiography.
The investigators will include patients with anterior ischaemic optic neuropathy and normal patients. For each participant, the investigators will estimate the best visual acuity, intra-ocular pressure, make a fondus, measurement of retinal nervous layer thickness, ganglionar cells layer thickness, and a macular and papillar OCT angiography during a consultation (duration 30 min).
The investigators will be able to know if
- there is a modification of the peripapillary vascularisation subsequent to the occlusion of the posterior ciliary artery
- there is a difference between arteritic and non arteritic anterior ischaemic optic neuropathy,
- there is a repercussion of the neuropathy on the retinal layers,
- there is a difference in peripapillar vascularisation by age.
- Conditions
- Neuropathy, Optic
- Medical subject headings
- Optic Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with anterior ischaemic optic neuropathy | estimation of best visual acuity, fondus, measurement of retinal nervous layer thickness, ganglionar cells layer thickness, and a macular and papillar OCT angiography during a consultation | |
| control group. Normal eyes | estimation of best visual acuity, fondus, measurement of retinal nervous layer thickness, ganglionar cells layer thickness, and a macular and papillar OCT angiography during a consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare peripapillary vascular density in eyes with anterior ischaemic optic neuropathy and in normal eyes with OCT angiography
Measurement of vascular density by percentage of area occupied by peripapillary vessels in patients with anterior ischemic optic neuropathy and control subjects
Measured: 10 minutes
Secondary outcomes (5)
compare vascular microvascular density at the macular level with angio-OCT in patients with anterior ischemic optic neuropathy and control subjects
Measurement of macular microvascular density by percentage of the area occupied by the vessels in patients with anterior ischemic optic neuropathy and control subjects,
Measured: 10 minutes
Compare Peripapillary and Macular Mirovascular Differences in Arteritic and Non-Arteritic anterior ischemic optic neuropathy Patients
Measurement of microvascularisation density and its abnormalities (dilatation, defect) on peripapillary angio-OCT images in group with an arteritic optic neuropathy compared to patients with non-arteritic optic neuropathy
Measured: 10 minutes
compare the microvascular density of the 2 optic discs in the same patient : with optic neuropathy and the healthy disc
Measurement of peripapillary microvascular density in the eye with anterior ischemic optic neuropathy and healthy contralateral eye in the same patient
Measured: 10 minutes
compare the thickness of the peripapillary retinal nerve fibers and the thickness of the ganglionar complex layer in patients with anterior ischemic optic neuropathy and control group
Measurement of retinal nerve fiber thickness (RNFL), and thickness of ganglionic complex layer (GCC) with OCT in 2 groups
Measured: 5 minutes
Compare peripapillary and macular microvascular density by age and by sex
Measurement of macular and peripapillary microvascular density on angio-OCT images for comparison between different age groups
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start29 Aug 2018
- Primary completion4 Jun 2019
- Study completion4 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Neuropathy, OpticStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642899
- Sponsor's protocol ID
- NOIA
- Acronym
- NOIA
- Status last verified
- Jul 2019
- First submitted
- 20 Aug 2018
- Last updated
- 10 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Balducci N, Morara M, Veronese C, Barboni P, Casadei NL, Savini G, Parisi V, Sadun AA, Ciardella A. Optical coherence tomography angiography in acute arteritic and non-arteritic anterior ischemic optic neuropathy. Graefes Arch Clin Exp Ophthalmol. 2017 Nov;255(11):2255-2261. doi: 10.1007/s00417-017-3774-y. Epub 2017 Aug 31.
PubMed 28861697Berry S, Lin WV, Sadaka A, Lee AG. Nonarteritic anterior ischemic optic neuropathy: cause, effect, and management. Eye Brain. 2017 Sep 27;9:23-28. doi: 10.2147/EB.S125311. eCollection 2017.
PubMed 29033621Gaier ED, Gilbert AL, Cestari DM, Miller JB. Optical coherence tomographic angiography identifies peripapillary microvascular dilation and focal non-perfusion in giant cell arteritis. Br J Ophthalmol. 2018 Aug;102(8):1141-1146. doi: 10.1136/bjophthalmol-2017-310718. Epub 2017 Nov 9.
PubMed 29122818Hata M, Oishi A, Muraoka Y, Miyamoto K, Kawai K, Yokota S, Fujimoto M, Miyata M, Yoshimura N. Structural and Functional Analyses in Nonarteritic Anterior Ischemic Optic Neuropathy: Optical Coherence Tomography Angiography Study. J Neuroophthalmol. 2017 Jun;37(2):140-148. doi: 10.1097/WNO.0000000000000470.
PubMed 27984351Ling JW, Yin X, Lu QY, Chen YY, Lu PR. Optical coherence tomography angiography of optic disc perfusion in non-arteritic anterior ischemic optic neuropathy. Int J Ophthalmol. 2017 Sep 18;10(9):1402-1406. doi: 10.18240/ijo.2017.09.12. eCollection 2017.
PubMed 28944200Liu CH, Kao LY, Sun MH, Wu WC, Chen HS. Retinal Vessel Density in Optical Coherence Tomography Angiography in Optic Atrophy after Nonarteritic Anterior Ischemic Optic Neuropathy. J Ophthalmol. 2017;2017:9632647. doi: 10.1155/2017/9632647. Epub 2017 Feb 19.
PubMed 28316838Moghimi S, Afzali M, Akbari M, Ebrahimi KB, Khodabande A, Yazdani-Abyaneh AR, Ghafouri SNH, Coh P, Okhravi S, Fard MA. Crowded optic nerve head evaluation with optical coherence tomography in anterior ischemic optic neuropathy. Eye (Lond). 2017 Aug;31(8):1191-1198. doi: 10.1038/eye.2017.56. Epub 2017 Apr 7.
PubMed 28387764Sharma S, Ang M, Najjar RP, Sng C, Cheung CY, Rukmini AV, Schmetterer L, Milea D. Optical coherence tomography angiography in acute non-arteritic anterior ischaemic optic neuropathy. Br J Ophthalmol. 2017 Aug;101(8):1045-1051. doi: 10.1136/bjophthalmol-2016-309245. Epub 2017 Jan 5.
PubMed 28057645Song Y, Min JY, Mao L, Gong YY. Microvasculature dropout detected by the optical coherence tomography angiography in nonarteritic anterior ischemic optic neuropathy. Lasers Surg Med. 2018 Mar;50(3):194-201. doi: 10.1002/lsm.22712. Epub 2017 Oct 7.
PubMed 28986994
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Peripapillary Vasculature With OCT-angiography in Arteritic and Non Arteritic Anterior Ischemic Neuropathy After Oedema Disappearance
- ClinicalTrials.gov ID
- NCT03642899
- Acronym / sponsor ID
- NOIA / NOIA
- Conditions
- Neuropathy, Optic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 4 Jun 2019 (actual)
- Study completion
- 4 Jun 2019 (actual)
- First posted
- 22 Aug 2018 (actual)
- 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.
Anterior ischaemic optic neuropathy results from infarction of retrolaminar portion of the optic nerve head, caused by occlusion of the posterior ciliary artery. Non arteritic anterior ischaemic optic neuropathy affects more frequently people between 50 and 70 years of age, with vasculopathic risk factors. Arteritic anterior ischaemic optic neuropathy is caused by the Horton disease, affects an older population and is an ophthalmologic emergency because of the bilateralisation's risk.
The aim of this study is to compare the peripapillar vascular density of anterior ischaemic optic neuropathy eyes (arteritic and non arteritic) with normal eyes after the disappearance of the papillar edema, with oCT-angiography.
The investigators will include patients with anterior ischaemic optic neuropathy and normal patients. For each participant, the investigators will estimate the best visual acuity, intra-ocular pressure, make a fondus, measurement of retinal nervous layer thickness, ganglionar cells layer thickness, and a macular and papillar OCT angiography during a consultation (duration 30 min).
The investigators will be able to know if
- there is a modification of the peripapillary vascularisation subsequent to the occlusion of the posterior ciliary artery
- there is a difference between arteritic and non arteritic anterior ischaemic optic neuropathy,
- there is a repercussion of the neuropathy on the retinal layers,
- there is a difference in peripapillar vascularisation by age.
Detailed description
Anterior ischaemic optic neuropathy results from infarction of retrolaminar portion of the optic nerve head, caused by occlusion of the posterior ciliary artery. Non arteritic anterior ischaemic optic neuropathy affects more frequently people between 50 and 70 years of age, with vasculopathic risk factors. Arteritic anterior ischaemic optic neuropathy is caused by the Horton disease, affects an older population and is an ophthalmologic emergency because of the bilateralisation's risk.
The aim of this study is to compare the peripapillar vascular density of anterior ischaemic optic neuropathy eyes (arteritic and non arteritic) with normal eyes after the disappearance of the papillar edema, with oCT-angiography.
The investigators will include patients with anterior ischaemic optic neuropathy and normal patients. For each participant, the investigators will estimate the best visual acuity, intra-ocular pressure, make a fondus, measurement of retinal nervous layer thickness, ganglionar cells layer thickness, and a macular and papillar OCT angiography during a consultation (duration 30 min).
The investigators will be able to know if
- there is a modification of the peripapillary vascularisation subsequent to the occlusion of the posterior ciliary artery
- there is a difference between arteritic and non arteritic anterior ischaemic optic neuropathy,
- there is a repercussion of the neuropathy on the retinal layers,
- there is a difference in peripapillar vascularisation by age.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with anterior ischaemic optic neuropathy | – | –estimation of best visual acuity, fondus, measurement of retinal nervous layer thickness, ganglionar cells layer thickness, and a macular and papillar OCT angiography during a consultation |
| control group. Normal eyes | – | –estimation of best visual acuity, fondus, measurement of retinal nervous layer thickness, ganglionar cells layer thickness, and a macular and papillar OCT angiography during a consultation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients with arteritic or non-arteritic anterior ischemic optic neuropathy ,> 3 months or after disappearance of papillary edema * Control subjects, with normal optic nerve and symmetrical appearance
Key inclusion criteria (6 listed)
- Patients with arteritic or non-arteritic anterior ischemic optic neuropathy ,> 3 months or after disappearance of papillary edema
- Control subjects, with normal optic nerve and symmetrical appearance , without diagnosed glaucoma (intraocular tension lower than 21mmHg) and without antecedent of retinal or intraorbital pathology.
- Patient with cataract can be included, within the limits of the good acquisition of images.
- Free, without tutorship or curatorship or subordination
- Benefiting from a Social Security scheme or benefiting through a third party
Key exclusion criteria (6 listed)
- with ocular or retinal pathology leading to irreversible visual impairment or macular involvement (strong myopia> 6 diopters, astigmatism> 3 diopters, retinitis pigmentosa, occlusion of the central artery of the retina or central vein of the retina , CRSC, diabetic retinopathy), or history of ocular or retinal surgery except cataract surgery.
- having an alteration of the optic nerve related to another pathology (NORB, glaucoma evolved with cup / disc> 0.7 or poorly balanced tension, optic neuritis),
- performing the exam impossible or poor image quality
- impossibility of giving one's non-opposition,
- not benefiting from a social security scheme or benefiting from it through a third person
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
compare peripapillary vascular density in eyes with anterior ischaemic optic neuropathy and in normal eyes with OCT angiography
Time frame: 10 minutes
Measurement of vascular density by percentage of area occupied by peripapillary vessels in patients with anterior ischemic optic neuropathy and control subjects
5 secondary outcomes
compare vascular microvascular density at the macular level with angio-OCT in patients with anterior ischemic optic neuropathy and control subjects
Time frame: 10 minutes
Compare Peripapillary and Macular Mirovascular Differences in Arteritic and Non-Arteritic anterior ischemic optic neuropathy Patients
Time frame: 10 minutes
compare the microvascular density of the 2 optic discs in the same patient : with optic neuropathy and the healthy disc
Time frame: 10 minutes
compare the thickness of the peripapillary retinal nerve fibers and the thickness of the ganglionar complex layer in patients with anterior ischemic optic neuropathy and control group
Time frame: 5 minutes
Compare peripapillary and macular microvascular density by age and by sex
Time frame: 10 minutes
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 10 Jul 2019.
- Background: PubMed 28861697Balducci N, Morara M, Veronese C, Barboni P, Casadei NL, Savini G, Parisi V, Sadun AA, Ciardella A. Optical coherence tomography angiography in acute arteritic and non-arteritic anterior ischemic optic neuropathy. Graefes Arch Clin Exp Ophthalmol. 2017 Nov;255(11):2255-2261. doi: 10.1007/s00417-017-3774-y. Epub 2017 Aug 31.
- Background: PubMed 29033621Berry S, Lin WV, Sadaka A, Lee AG. Nonarteritic anterior ischemic optic neuropathy: cause, effect, and management. Eye Brain. 2017 Sep 27;9:23-28. doi: 10.2147/EB.S125311. eCollection 2017.
- Background: PubMed 29122818Gaier ED, Gilbert AL, Cestari DM, Miller JB. Optical coherence tomographic angiography identifies peripapillary microvascular dilation and focal non-perfusion in giant cell arteritis. Br J Ophthalmol. 2018 Aug;102(8):1141-1146. doi: 10.1136/bjophthalmol-2017-310718. Epub 2017 Nov 9.
- Background: PubMed 27984351Hata M, Oishi A, Muraoka Y, Miyamoto K, Kawai K, Yokota S, Fujimoto M, Miyata M, Yoshimura N. Structural and Functional Analyses in Nonarteritic Anterior Ischemic Optic Neuropathy: Optical Coherence Tomography Angiography Study. J Neuroophthalmol. 2017 Jun;37(2):140-148. doi: 10.1097/WNO.0000000000000470.
- Background: PubMed 28944200Ling JW, Yin X, Lu QY, Chen YY, Lu PR. Optical coherence tomography angiography of optic disc perfusion in non-arteritic anterior ischemic optic neuropathy. Int J Ophthalmol. 2017 Sep 18;10(9):1402-1406. doi: 10.18240/ijo.2017.09.12. eCollection 2017.
- Background: PubMed 28316838Liu CH, Kao LY, Sun MH, Wu WC, Chen HS. Retinal Vessel Density in Optical Coherence Tomography Angiography in Optic Atrophy after Nonarteritic Anterior Ischemic Optic Neuropathy. J Ophthalmol. 2017;2017:9632647. doi: 10.1155/2017/9632647. Epub 2017 Feb 19.
- Background: PubMed 28387764Moghimi S, Afzali M, Akbari M, Ebrahimi KB, Khodabande A, Yazdani-Abyaneh AR, Ghafouri SNH, Coh P, Okhravi S, Fard MA. Crowded optic nerve head evaluation with optical coherence tomography in anterior ischemic optic neuropathy. Eye (Lond). 2017 Aug;31(8):1191-1198. doi: 10.1038/eye.2017.56. Epub 2017 Apr 7.
- Background: PubMed 28057645Sharma S, Ang M, Najjar RP, Sng C, Cheung CY, Rukmini AV, Schmetterer L, Milea D. Optical coherence tomography angiography in acute non-arteritic anterior ischaemic optic neuropathy. Br J Ophthalmol. 2017 Aug;101(8):1045-1051. doi: 10.1136/bjophthalmol-2016-309245. Epub 2017 Jan 5.
- Background: PubMed 28986994Song Y, Min JY, Mao L, Gong YY. Microvasculature dropout detected by the optical coherence tomography angiography in nonarteritic anterior ischemic optic neuropathy. Lasers Surg Med. 2018 Mar;50(3):194-201. doi: 10.1002/lsm.22712. Epub 2017 Oct 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Neuropathy, Optic, run by Poitiers University Hospital at 1 site in France.
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 6 inclusion and 6 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 10 Jul 2019. 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 France. 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?
compare peripapillary vascular density in eyes with anterior ischaemic optic neuropathy and in normal eyes with OCT angiography (time frame: 10 minutes). 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 NCT03642899, which also lists 9 linked publications.
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 10 Jul 2019.