Relation Between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease Relation Between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease

NCT06296004 | Not Yet Recruiting

• 1 other identifier: CAPILLAROSCOPY behcet disease
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Relation between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease

Conditions

Behçet's Disease

Outcome Measures

Primary Outcomes (3)

• measuring parameter of Nail Fold Capillaroscopy in behcet disease

  using previous parameters in diagnosis of vascular affection in behcet disease

  1 year

• measuring parameter of Optical Coherence Tomography Angiography in behcet disease

  using previous parameters in diagnosis of vascular affection in behcet disease

  1 year

• measuring parameter of Femoral Vein Wall Thickness in behcet disease

  using previous parameters in diagnosis of vascular affection in behcet disease

  1year

Secondary Outcomes (3)

• relation between Nail Fold Capillaroscopy and activity of behcet disease

  1 years

• relation between Optical Coherence Tomography Angiography and activity of behcet disease

  1 year

• relation between Femoral Vein Wall Thickness and activity of behcet disease

  1 year

Study Arms (2)

adult patient with Behçet's Disease

. Adult BD patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease .

Device: Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness by U.S

healthy subjects

apparently healthy subjects

Device: Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness by U.S

Interventions

Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness by U.S DEVICE

Complete blood count (CBC) Erythrocyte sedimentation rate (ESR) measured by standard westergren method (mm/h). Serum C-reactive protein (CRP) Liver function tests: aspartate transaminase (AST), alanine transaminase (ALT), serum albumin, serum bilirubin. Renal function tests: serum creatinine and blood urea. Complete urine analysis. Optical coherence tomography angiography (OCTA): . Bilateral common femoral vein (CFV) Doppler US

adult patient with Behçet's Disease; healthy subjects

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study will include 80 participants: Group 1: 40 patients with who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease (Disease et al., 2014). . Group 2: 40 healthy matched controls.

You may qualify if:

• Adult BD patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease .
• Accept to participate in the current study -

You may not qualify if:

• Individuals with other autoimmune diseases (rheumatoid arthritis dermatomyositis, scleroderma, mixed connective tissue disease).
• Patients with high myopia or media opacities preventing high-quality imaging like cataract and cornea guttata, vitreoretinal disease, previous retinal surgery, macular edema, glaucoma or neurological disease.
• Patients with other comorbidities as diabetes, hypertension were excluded from the study.
• Refused to participate in the current study.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (19)

• Alibaz-Oner F, Ergelen R, Yildiz Y, Aldag M, Yazici A, Cefle A, Koc E, Artim Esen B, Mumcu G, Ergun T, Direskeneli H. Femoral vein wall thickness measurement: A new diagnostic tool for Behcet's disease. Rheumatology (Oxford). 2021 Jan 5;60(1):288-296. doi: 10.1093/rheumatology/keaa264.

  PMID: 32756998 BACKGROUND

• Alibaz-Oner F, Direskeneli H. Assessment of venous wall thickness with Doppler ultrasonography may be a diagnostic tool for Behcet's disease. Int J Rheum Dis. 2019 May;22(5):767-768. doi: 10.1111/1756-185X.13574. No abstract available.

  PMID: 31062939 BACKGROUND

• Alten F, Heiduschka P, Clemens CR, Eter N. Exploring choriocapillaris under reticular pseudodrusen using OCT-Angiography. Graefes Arch Clin Exp Ophthalmol. 2016 Nov;254(11):2165-2173. doi: 10.1007/s00417-016-3375-1. Epub 2016 May 18.

  PMID: 27193430 BACKGROUND

• Bhakta BB, Brennan P, James TE, Chamberlain MA, Noble BA, Silman AJ. Behcet's disease: evaluation of a new instrument to measure clinical activity. Rheumatology (Oxford). 1999 Aug;38(8):728-33. doi: 10.1093/rheumatology/38.8.728.

  PMID: 10501420 BACKGROUND

• Bonini Filho MA, Adhi M, de Carlo TE, Ferrara D, Baumal CR, Witkin AJ, Reichel E, Kuehlewein L, Sadda SR, Sarraf D, Duker JS, Waheed NK. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY IN RETINAL ARTERY OCCLUSION. Retina. 2015 Nov;35(11):2339-46. doi: 10.1097/IAE.0000000000000850.

  PMID: 26457398 BACKGROUND

• Cheng D, Shen M, Zhuang X, Lin D, Dai M, Chen S, Lu F, Wang Y. Inner Retinal Microvasculature Damage Correlates With Outer Retinal Disruption During Remission in Behcet's Posterior Uveitis by Optical Coherence Tomography Angiography. Invest Ophthalmol Vis Sci. 2018 Mar 1;59(3):1295-1304. doi: 10.1167/iovs.17-23113.

  PMID: 29625452 BACKGROUND

• Chojnowski MM, Felis-Giemza A, Olesinska M. Capillaroscopy - a role in modern rheumatology. Reumatologia. 2016;54(2):67-72. doi: 10.5114/reum.2016.60215. Epub 2016 Jun 3.

  PMID: 27407282 BACKGROUND

• de Carlo TE, Romano A, Waheed NK, Duker JS. A review of optical coherence tomography angiography (OCTA). Int J Retina Vitreous. 2015 Apr 15;1:5. doi: 10.1186/s40942-015-0005-8. eCollection 2015.

  PMID: 27847598 BACKGROUND

• International Team for the Revision of the International Criteria for Behcet's Disease (ITR-ICBD). The International Criteria for Behcet's Disease (ICBD): a collaborative study of 27 countries on the sensitivity and specificity of the new criteria. J Eur Acad Dermatol Venereol. 2014 Mar;28(3):338-47. doi: 10.1111/jdv.12107. Epub 2013 Feb 26.

  PMID: 23441863 BACKGROUND

• Khairallah M, Abroug N, Khochtali S, Mahmoud A, Jelliti B, Coscas G, Lupidi M, Kahloun R, Ben Yahia S. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY IN PATIENTS WITH BEHCET UVEITIS. Retina. 2017 Sep;37(9):1678-1691. doi: 10.1097/IAE.0000000000001418.

  PMID: 28002270 BACKGROUND

• Lupidi M, Cerquaglia A, Chhablani J, Fiore T, Singh SR, Cardillo Piccolino F, Corbucci R, Coscas F, Coscas G, Cagini C. Optical coherence tomography angiography in age-related macular degeneration: The game changer. Eur J Ophthalmol. 2018 Jul;28(4):349-357. doi: 10.1177/1120672118766807. Epub 2018 Apr 6.

  PMID: 29623720 BACKGROUND

• • Onan, D., Uysal, P., Hayran, Y., Şahin Dalgıç, G., Hayran, M., Artüz, F. & Yalçin, B. (2019) Dermatoscopic Assessment of Nailfold Capillary Abnormalities in Behçet's Disease and Correlation of the Findings with Disease Activity and Severity. Dermatologica Sinica, 37, 40-45.

  BACKGROUND

• Samara WA, Shahlaee A, Adam MK, Khan MA, Chiang A, Maguire JI, Hsu J, Ho AC. Quantification of Diabetic Macular Ischemia Using Optical Coherence Tomography Angiography and Its Relationship with Visual Acuity. Ophthalmology. 2017 Feb;124(2):235-244. doi: 10.1016/j.ophtha.2016.10.008. Epub 2016 Nov 23.

  PMID: 27887743 BACKGROUND

• Samara WA, Shahlaee A, Sridhar J, Khan MA, Ho AC, Hsu J. Quantitative Optical Coherence Tomography Angiography Features and Visual Function in Eyes With Branch Retinal Vein Occlusion. Am J Ophthalmol. 2016 Jun;166:76-83. doi: 10.1016/j.ajo.2016.03.033. Epub 2016 Mar 31.

  PMID: 27038893 BACKGROUND

• Sambhav K, Grover S, Chalam KV. The application of optical coherence tomography angiography in retinal diseases. Surv Ophthalmol. 2017 Nov-Dec;62(6):838-866. doi: 10.1016/j.survophthal.2017.05.006. Epub 2017 Jun 1.

  PMID: 28579550 BACKGROUND

• Somkijrungroj T, Vongkulsiri S, Kongwattananon W, Chotcomwongse P, Luangpitakchumpol S, Jaisuekul K. Assessment of Vascular Change Using Swept-Source Optical Coherence Tomography Angiography: A New Theory Explains Central Visual Loss in Behcet's Disease. J Ophthalmol. 2017;2017:2180723. doi: 10.1155/2017/2180723. Epub 2017 May 9.

  PMID: 28596917 BACKGROUND

• Spaide RF, Fujimoto JG, Waheed NK, Sadda SR, Staurenghi G. Optical coherence tomography angiography. Prog Retin Eye Res. 2018 May;64:1-55. doi: 10.1016/j.preteyeres.2017.11.003. Epub 2017 Dec 8.

  PMID: 29229445 BACKGROUND

• Tugal-Tutkun I, Ozdal PC, Oray M, Onal S. Review for Diagnostics of the Year: Multimodal Imaging in Behcet Uveitis. Ocul Immunol Inflamm. 2017 Feb;25(1):7-19. doi: 10.1080/09273948.2016.1205100. Epub 2016 Aug 19.

  PMID: 27541278 BACKGROUND

• Yilmaz PT, Ozdemir EY, Alp MN. Optical coherence tomography angiography findings in patients with ocular and non-ocular Behcet disease. Arq Bras Oftalmol. 2021 May-Jun;84(3):235-240. doi: 10.5935/0004-2749.20210031.

  PMID: 33567020 BACKGROUND

MeSH Terms

Conditions

Behcet Syndrome

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Central Study Contacts

Eman Hamed, professor doctor

CONTACT

01066643425

El. Zahraa Ahmed, Ass Lec.

CONTACT

01033585868; awnyzahraa@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 6, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share