Optic Coherence Tomography in Patients With Amyotrophic Lateral Sclerosis
NCT ID: NCT03377868
Last Updated: 2017-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2018-01-03
2018-09-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Patients with Amyotrophic lateral sclerosis
Patients diagnosed with amyotrophic lateral sclerosis
Optic coherence tomography
Optic coherence tomography measures retinal layer thickness, macular volume , and cell inner plexiform layer.
Pulmonary function test
Pulmonary function test measures forced vital capacity and forced expiratory volume in one second.
Control
Parallel cohort of healthy age and sex matched subjects
Optic coherence tomography
Optic coherence tomography measures retinal layer thickness, macular volume , and cell inner plexiform layer.
Pulmonary function test
Pulmonary function test measures forced vital capacity and forced expiratory volume in one second.
Interventions
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Optic coherence tomography
Optic coherence tomography measures retinal layer thickness, macular volume , and cell inner plexiform layer.
Pulmonary function test
Pulmonary function test measures forced vital capacity and forced expiratory volume in one second.
Eligibility Criteria
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Inclusion Criteria
* Age 18 years to 80 years old
* Disease duration less than 36 months
* Patients logistically able to attend and be evaluated at baseline, 3 and 6 months
Exclusion Criteria
* Patients with glaucoma, refractive errors of ± 6 diopters or more, or other ophthalmologic disorders such as media opacities that could interfere with retinal OCT assessment
ALL
Yes
Sponsors
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American University of Beirut Medical Center
OTHER
Responsible Party
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Achraf Makki
Assistant professor
Central Contacts
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References
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Calvo AC, Manzano R, Mendonca DM, Munoz MJ, Zaragoza P, Osta R. Amyotrophic lateral sclerosis: a focus on disease progression. Biomed Res Int. 2014;2014:925101. doi: 10.1155/2014/925101. Epub 2014 Aug 3.
Grosskreutz J, Kaufmann J, Fradrich J, Dengler R, Heinze HJ, Peschel T. Widespread sensorimotor and frontal cortical atrophy in Amyotrophic Lateral Sclerosis. BMC Neurol. 2006 Apr 25;6:17. doi: 10.1186/1471-2377-6-17.
Hammad M, Silva A, Glass J, Sladky JT, Benatar M. Clinical, electrophysiologic, and pathologic evidence for sensory abnormalities in ALS. Neurology. 2007 Dec 11;69(24):2236-42. doi: 10.1212/01.wnl.0000286948.99150.16.
Radtke RA, Erwin A, Erwin CW. Abnormal sensory evoked potentials in amyotrophic lateral sclerosis. Neurology. 1986 Jun;36(6):796-801. doi: 10.1212/wnl.36.6.796.
Munte TF, Troger MC, Nusser I, Wieringa BM, Johannes S, Matzke M, Dengler R. Alteration of early components of the visual evoked potential in amyotrophic lateral sclerosis. J Neurol. 1998 Apr;245(4):206-10. doi: 10.1007/s004150050206.
Moss HE, McCluskey L, Elman L, Hoskins K, Talman L, Grossman M, Balcer LJ, Galetta SL, Liu GT. Cross-sectional evaluation of clinical neuro-ophthalmic abnormalities in an amyotrophic lateral sclerosis population. J Neurol Sci. 2012 Mar 15;314(1-2):97-101. doi: 10.1016/j.jns.2011.10.016. Epub 2011 Dec 21.
Huang D, Swanson EA, Lin CP, Schuman JS, Stinson WG, Chang W, Hee MR, Flotte T, Gregory K, Puliafito CA, et al. Optical coherence tomography. Science. 1991 Nov 22;254(5035):1178-81. doi: 10.1126/science.1957169.
Puliafito CA, Hee MR, Lin CP, Reichel E, Schuman JS, Duker JS, Izatt JA, Swanson EA, Fujimoto JG. Imaging of macular diseases with optical coherence tomography. Ophthalmology. 1995 Feb;102(2):217-29. doi: 10.1016/s0161-6420(95)31032-9.
Jimenez B, Ascaso FJ, Cristobal JA, Lopez del Val J. Development of a prediction formula of Parkinson disease severity by optical coherence tomography. Mov Disord. 2014 Jan;29(1):68-74. doi: 10.1002/mds.25747. Epub 2013 Nov 14.
Ascaso FJ, Cruz N, Modrego PJ, Lopez-Anton R, Santabarbara J, Pascual LF, Lobo A, Cristobal JA. Retinal alterations in mild cognitive impairment and Alzheimer's disease: an optical coherence tomography study. J Neurol. 2014 Aug;261(8):1522-30. doi: 10.1007/s00415-014-7374-z. Epub 2014 May 21.
Bertuzzi F, Suzani M, Tagliabue E, Cavaletti G, Angeli R, Balgera R, Rulli E, Ferrarese C, Miglior S. Diagnostic validity of optic disc and retinal nerve fiber layer evaluations in detecting structural changes after optic neuritis. Ophthalmology. 2010 Jun;117(6):1256-1264.e1. doi: 10.1016/j.ophtha.2010.02.024. Epub 2010 Apr 9.
Bennett JL, de Seze J, Lana-Peixoto M, Palace J, Waldman A, Schippling S, Tenembaum S, Banwell B, Greenberg B, Levy M, Fujihara K, Chan KH, Kim HJ, Asgari N, Sato DK, Saiz A, Wuerfel J, Zimmermann H, Green A, Villoslada P, Paul F; GJCF-ICC&BR. Neuromyelitis optica and multiple sclerosis: Seeing differences through optical coherence tomography. Mult Scler. 2015 May;21(6):678-88. doi: 10.1177/1352458514567216. Epub 2015 Feb 6.
Roth NM, Saidha S, Zimmermann H, Brandt AU, Oberwahrenbrock T, Maragakis NJ, Tumani H, Ludolph AC, Meyer T, Calabresi PA, Paul F. Optical coherence tomography does not support optic nerve involvement in amyotrophic lateral sclerosis. Eur J Neurol. 2013 Aug;20(8):1170-6. doi: 10.1111/ene.12146. Epub 2013 Apr 14.
Ringelstein M, Albrecht P, Sudmeyer M, Harmel J, Muller AK, Keser N, Finis D, Ferrea S, Guthoff R, Schnitzler A, Hartung HP, Methner A, Aktas O. Subtle retinal pathology in amyotrophic lateral sclerosis. Ann Clin Transl Neurol. 2014 Apr;1(4):290-7. doi: 10.1002/acn3.46. Epub 2014 Mar 11.
Simonett JM, Huang R, Siddique N, Farsiu S, Siddique T, Volpe NJ, Fawzi AA. Macular sub-layer thinning and association with pulmonary function tests in Amyotrophic Lateral Sclerosis. Sci Rep. 2016 Jul 7;6:29187. doi: 10.1038/srep29187.
Saidha S, Al-Louzi O, Ratchford JN, Bhargava P, Oh J, Newsome SD, Prince JL, Pham D, Roy S, van Zijl P, Balcer LJ, Frohman EM, Reich DS, Crainiceanu C, Calabresi PA. Optical coherence tomography reflects brain atrophy in multiple sclerosis: A four-year study. Ann Neurol. 2015 Nov;78(5):801-13. doi: 10.1002/ana.24487. Epub 2015 Oct 1.
Other Identifiers
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IM.AS.01
Identifier Type: -
Identifier Source: org_study_id