Clinical trial NCT04601805: Optical Coherence Tomography Angiography Assessment of Retinal Lesions in Inflammatory Bowel Diseases
Official title: Optical Coherence Tomography Angiography Assessment of Retinal Lesions in Inflammatory Bowel Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This will be a prospective study of 30 patients suffering from Inflammatory bowel disease referred from tropical department from Tanta University Hospital

Brief summary: Aim of the study;To record the vascular changes that may be present in the posterior segment of patients suffering from Inflammatory bowel diseases(IBD) using the optical coherence tomography angiography

Detailed description: a prospective study of 30 patients suffering from IBD referred from tropical department from Tanta University Hospital

-Patients demographic data e.g., sex, age, concomitant systemic diseases will be recruited. Presenting symptoms, physical examination results, laboratory and imaging findings, and received treatment of IBD will be recorded. Accurate grading of disease severity will be carried out by gastroenterology specialist.

All patients will be subject to Full ophthalmologic examination and fundus imaging. Imaging will include OCTA and fundus photography. OCTA will be performed using cirrus OCT (Zeiss, Inc., USA). High-quality 6 x 6 mm OCTA macular scans and 3 × 3-mm papillary scan with strong signal-noise ratio and adequate centration on the fovea and optic nerve head respectively will be selected. Segmentation will be used to evaluate superﬁcial and deep capillary retinal plexus projections in addition to the choriocapillaries. If errors in segmentation were detected, manual correction would be performed. The superﬁcial retinal capillary plexus (SCP) will be delineated with an inner boundary at the internal limiting membrane (ILM) and an outer boundary 10 µm inside the inner plexiform layer (IPL). The deep retinal capillary plexus (DCP) will be segmented with an inner boundary 10 µm inside the IPL and an outer boundary at 10 µm beneath the outer plexiform layer (OPL).

The vessel density metric from enface OCT angiogram will be used as an indicator of macular retinal and papillary perfusion. Vessel density (VD) analysis computes the percentage of area occupied by OCTA detected vasculature in a measured area. Choriocapillaries flow voids will be computed to assess choriocapillaries circulation

Eligibility criteria: Inclusion Criteria:

* Patients with Crohn's disease and ulcerative colitis either newly diagnosed or suffering from chronic disease on treatment will be included

Exclusion Criteria:

* Recent ophthalmological surgery.

  * Low quality ophthalmological exams.
  * Refractive errors greater than + 3 or - 3 spherical.
  * Retinopathies such as diabetic retinopathy.
  * Any type of retinal degenerations or retinal dystrophy.

Primary outcomes:
measure: vascular changes in the posterior segment of patients suffering from inflammatory bowel disease using the optical coherence tomography angiography
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospital
state: El-Garbeia
Study officials:
References:
citation: Silva FA, Rodrigues BL, Ayrizono ML, Leal RF. The Immunological Basis of Inflammatory Bowel Disease. Gastroenterol Res Pract. 2016;2016:2097274. doi: 10.1155/2016/2097274. Epub 2016 Dec 14.
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citation: Ghanchi FD, Rembacken BJ. Inflammatory bowel disease and the eye. Surv Ophthalmol. 2003 Nov-Dec;48(6):663-76. doi: 10.1016/j.survophthal.2003.08.004.
citation: Troncoso LL, Biancardi AL, de Moraes HV Jr, Zaltman C. Ophthalmic manifestations in patients with inflammatory bowel disease: A review. World J Gastroenterol. 2017 Aug 28;23(32):5836-5848. doi: 10.3748/wjg.v23.i32.5836.
citation: Familiari L, Strangio G, Consolo P, Luigiano C, Bonica M, Barresi G, Barresi V, Familiari P, D'Arrigo G, Alibrandi A, Zirilli A, Fries W, Scaffidi M. Optical coherence tomography evaluation of ulcerative colitis: the patterns and the comparison with histology. Am J Gastroenterol. 2006 Dec;101(12):2833-40. doi: 10.1111/j.1572-0241.2006.00826.x.
citation: Yilmaz S, Aydemir E, Maden A, Unsal B. The prevalence of ocular involvement in patients with inflammatory bowel disease. Int J Colorectal Dis. 2007 Sep;22(9):1027-30. doi: 10.1007/s00384-007-0275-1. Epub 2007 Jan 30.
citation: Or C, Sabrosa AS, Sorour O, Arya M, Waheed N. Use of OCTA, FA, and Ultra-Widefield Imaging in Quantifying Retinal Ischemia: A Review. Asia Pac J Ophthalmol (Phila). 2018 Jan-Feb;7(1):46-51. doi: 10.22608/APO.201812. Epub 2018 Feb 13.