Inflammatory Bowel DiseasesNCT04601805
Optical Coherence Tomography Angiography Assessment of Retinal Lesions in Inflammatory Bowel Diseases
An observational study of Inflammatory Bowel Diseases, run by Tanta University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Observation
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Apr 2021to 29 Dec 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This will be a prospective study of 30 patients suffering from Inflammatory bowel disease referred from tropical department from Tanta University Hospital
Who may be able to join
- Patients with Crohn's disease and ulcerative colitis either newly diagnosed or suffering from chronic disease on treatment will be included
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospital
Tanta, El-Garbeia, 31515
Dina Tadros, MD
About this study
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
Read the 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
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Observation
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationDevice
We will record the vascular changes that follow the inflammatory bowel diseases
| Study group | Role | What they receive |
|---|---|---|
| Group (1) : Patient diagnosed with IBD with no treatment received | Not described Receives: Device: Observation | |
| Group(2): Patient diagnosed with IBD and received treatment for a long time | Not described Receives: Device: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start13 Apr 2021
- Primary completion31 Dec 2021
- Study completion29 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Tadros, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601805
- Sponsor's protocol ID
- 34002/8/20
- Status last verified
- Dec 2023
- First submitted
- 13 Oct 2020
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 28070181Zhang YZ, Li YY. Inflammatory bowel disease: pathogenesis. World J Gastroenterol. 2014 Jan 7;20(1):91-9. doi: 10.3748/wjg.v20.i1.91.
PubMed 24415861Ghanchi 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.
PubMed 14609712Troncoso 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.
PubMed 28932076Familiari 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.
PubMed 17227526Yilmaz 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.
PubMed 17262200Or 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.
PubMed 29436208
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Angiography Assessment of Retinal Lesions in Inflammatory Bowel Diseases
- ClinicalTrials.gov ID
- NCT04601805
- Acronym / sponsor ID
- 34002/8/20
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 29 Dec 2024 (estimated)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This will be a prospective study of 30 patients suffering from Inflammatory bowel disease referred from tropical department from Tanta University Hospital
Key inclusion criteria (1 listed)
- Patients with Crohn's disease and ulcerative colitis either newly diagnosed or suffering from chronic disease on treatment will be included
Key exclusion criteria (5 listed)
- Recent ophthalmological surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationWe will record the vascular changes that follow the inflammatory bowel diseases | Device | Group (1) : Patient diagnosed with IBD with no treatment received, Group(2): Patient diagnosed with IBD and received treatment for a long time |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Results publication: PubMed 28070181Silva 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.
- Results publication: PubMed 24415861Zhang YZ, Li YY. Inflammatory bowel disease: pathogenesis. World J Gastroenterol. 2014 Jan 7;20(1):91-9. doi: 10.3748/wjg.v20.i1.91.
- Results publication: PubMed 14609712Ghanchi 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.
- Results publication: PubMed 28932076Troncoso 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.
- Results publication: PubMed 17227526Familiari 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.
- Results publication: PubMed 17262200Yilmaz 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.
- Results publication: PubMed 29436208Or 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina SM Tadros, MD (00201224093354, dinasabry@rocketmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vascular changes in the posterior segment of patients suffering from inflammatory bowel disease using the optical coherence tomography angiography (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04601805, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.