OCT Angiography in Arteritic and Non Arteritic Anterior Ischemic Neuropathy

NCT03642899 | Completed

• 1 other identifier: NOIA
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• compare vascular microvascular density at the macular level with angio-OCT in patients with anterior ischemic optic neuropathy and control subjects

  10 minutes

• Compare Peripapillary and Macular Mirovascular Differences in Arteritic and Non-Arteritic anterior ischemic optic neuropathy Patients

  10 minutes

• compare the microvascular density of the 2 optic discs in the same patient : with optic neuropathy and the healthy disc

  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

  5 minutes

• Compare peripapillary and macular microvascular density by age and by sex

  10 minutes

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU Poitiers

Poitiers, 86000, France

Location

Related Publications (9)

• 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.

  PMID: 28861697 BACKGROUND

• 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.

  PMID: 29033621 BACKGROUND

• 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.

  PMID: 29122818 BACKGROUND

• 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.

  PMID: 27984351 BACKGROUND

• 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.

  PMID: 28944200 BACKGROUND

• 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.

  PMID: 28316838 BACKGROUND

• 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.

  PMID: 28387764 BACKGROUND

• 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.

  PMID: 28057645 BACKGROUND

• 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.

  PMID: 28986994 BACKGROUND

MeSH Terms

Conditions

Optic Nerve Diseases

Condition Hierarchy (Ancestors)

Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 22, 2018
• Study Start: August 29, 2018
• Primary Completion: June 4, 2019
• Study Completion: June 4, 2019
• Last Updated: July 10, 2019

Record last verified: 2019-07

Locations

FR (1)