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Clinical Trials/NCT04601805
NCT04601805
Recruiting
Not Applicable

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

Tanta University1 site in 1 country30 target enrollmentApril 13, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inflammatory Bowel Diseases
Sponsor
Tanta University
Enrollment
30
Locations
1
Primary Endpoint
vascular changes in the posterior segment of patients suffering from inflammatory bowel disease using the optical coherence tomography angiography
Status
Recruiting
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
April 13, 2021
End Date
December 29, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dina Tadros

Lecturer of Ophthalmology, Tanta University, Egypt

Tanta University

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.

Outcomes

Primary Outcomes

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

Time Frame: 1 month

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.

Study Sites (1)

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