Neuropathy, Optic Clinical Trial
— NOIAOfficial title:
Study of Peripapillary Vasculature With OCT-angiography in Arteritic and Non Arteritic Anterior Ischemic Neuropathy After Oedema Disappearance
| NCT number | NCT03642899 |
| Other study ID # | NOIA |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 29, 2018 |
| Est. completion date | June 4, 2019 |
| Verified date | July 2019 |
| Source | Poitiers University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 17 |
| Est. completion date | June 4, 2019 |
| Est. primary completion date | June 4, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Poitiers | Poitiers |
| Lead Sponsor | Collaborator |
|---|---|
| Poitiers University Hospital |
France,
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. — View Citation
Berry 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. Review. — View Citation
Gaier 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. — View Citation
Hata 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. — View Citation
Ling 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. — View Citation
Liu 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. — View Citation
Moghimi 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. — View Citation
Sharma 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. — View Citation
Song 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 10 minutes | |
| Secondary | 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, | 10 minutes | |
| Secondary | 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 | 10 minutes | |
| Secondary | 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 | 10 minutes | |
| Secondary | 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 | 5 minutes | |
| Secondary | 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 | 10 minutes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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