Optical Coherence Tomography Angiography Assessment of Retinal Lesions in Inflammatory Bowel Diseases

NCT04601805 | Unknown DMC FDA Device

• 1 other identifier: 34002/8/20
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• vascular changes in the posterior segment of patients suffering from inflammatory bowel disease using the optical coherence tomography angiography

  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 withadequate centration on the fovea and optic nerve head Segmentation will be used to evaluate superficial and deep capillary retinal plexus projections in addition to the choriocapillaries. 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 as an indicator of macular retinal and papillary perfusion.

  1 month

Study Arms (2)

Group (1) : Patient diagnosed with IBD with no treatment received

Device: Observation

Group(2): Patient diagnosed with IBD and received treatment for a long time

Device: Observation

Interventions

Observation DEVICE

We will record the vascular changes that follow the inflammatory bowel diseases

Group (1) : Patient diagnosed with IBD with no treatment received; Group(2): Patient diagnosed with IBD and received treatment for a long time

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospital

Tanta, El-Garbeia, 31515, Egypt

RECRUITING

Related Publications (7)

• 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.

  PMID: 28070181 RESULT

• Zhang YZ, Li YY. Inflammatory bowel disease: pathogenesis. World J Gastroenterol. 2014 Jan 7;20(1):91-9. doi: 10.3748/wjg.v20.i1.91.

  PMID: 24415861 RESULT

• 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.

  PMID: 14609712 RESULT

• 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.

  PMID: 28932076 RESULT

• 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.

  PMID: 17227526 RESULT

• 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.

  PMID: 17262200 RESULT

• 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.

  PMID: 29436208 RESULT

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Observation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Dina SM Tadros, MD

CONTACT

00201224093354; dinasabry@rocketmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Ophthalmology, Tanta University, Egypt

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 26, 2020
• Study Start: April 13, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 29, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-12

Locations

EG (1)