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

Sponsor

Tanta University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04601805

Collaborator

(none)

Enrollment

Location

15.5

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

30 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 13, 2021

Actual Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Jul 29, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta University Hospital	Tanta	El-Garbeia	Egypt	31515

Sponsors and Collaborators

Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Oct 26, 2020

Last Update Posted:

Feb 8, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Intestinal Diseases

Inflammatory Bowel Diseases

Study Results

No Results Posted as of Feb 8, 2022