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

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ClinicalTrials.gov Identifier: NCT04601805
Recruitment Status : Not yet recruiting
First Posted : October 26, 2020
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
Dina Tadros, Tanta University

Tracking Information
First Submitted Date October 13, 2020
First Posted Date October 26, 2020
Last Update Posted Date October 26, 2020
Estimated Study Start Date November 1, 2020
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 20, 2020)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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

Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 1 Month
Biospecimen Not Provided
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
Condition Inflammatory Bowel Diseases
Intervention Device: Observation
We will record the vascular changes that follow the inflammatory bowel diseases
Study Groups/Cohorts
  • Group (1) : Patient diagnosed with IBD with no treatment received
    Intervention: Device: Observation
  • Group(2): Patient diagnosed with IBD and received treatment for a long time
    Intervention: Device: Observation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: October 20, 2020)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 29, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Dina SM Tadros, MD 00201224093354 dinasabry@rocketmail.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04601805
Other Study ID Numbers 34002/8/20
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Dina Tadros, Tanta University
Study Sponsor Tanta University
Collaborators Not Provided
Investigators Not Provided
PRS Account Tanta University
Verification Date October 2020