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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Device: Observation

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Optical Coherence Tomography Angiography Assessment of Retinal Lesions in Inflammatory Bowel Diseases
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : July 29, 2021

Group/Cohort Intervention/treatment
Group (1) : Patient diagnosed with IBD with no treatment received Device: Observation
We will record the vascular changes that follow the inflammatory bowel diseases

Group(2): Patient diagnosed with IBD and received treatment for a long time Device: Observation
We will record the vascular changes that follow the inflammatory bowel diseases




Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04601805


Contacts
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Contact: Dina SM Tadros, MD 00201224093354 dinasabry@rocketmail.com

Sponsors and Collaborators
Tanta University
Publications of Results:
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Responsible Party: Dina Tadros, Lecturer of Ophthalmology, Tanta University, Egypt, Tanta University
ClinicalTrials.gov Identifier: NCT04601805    
Other Study ID Numbers: 34002/8/20
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis