Choroid DiseaseNCT06272851
Measuring Choroidal Thickness Using Optical Coherence Tomography
An observational study of Choroid Disease and Diabetes Mellitus, run by Assiut University.
Trial summary
To compare the choroidal thickness in eyes of diabetic patients with eyes of age matched controls using optical coherence tomography. Read more about this study
- Who is it for?
- Ages 30 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Choroid Disease, Diabetes Mellitus
- What is being tested?
- optical coherence tomography
- Type of treatment
- Medical device
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2024to 15 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: known Type 2 DM patients aged 30 to 95 years either gender with no history of ocular treatment and non-diabetic healthy individuals who come to the hosoital
Who may be able to join
- All known Type 2 DM patients aged 30 to 95 years either gender who presented to ophthalmology clinics in Assuit ophthalmology hospital with no history of ocular treatment (ocular treatment naïve) and visual acuity of 0.1 (6/60) or more that are able to complete an eye examination, and non-diabetic healthy individuals (HbA1c <7) will be included in the study.
Who cannot join
- Known diagnosis of any other retinal disease, glaucoma, neurodegenerative disease, and any significant media opacities that precluded fundus imaging and not giving consent will be excluded.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparing the Choroidal Thickness Using Optical Coherence Tomography Between the Eyes of Healthy Individuals and Diabetic Patients Without Retinopathy
To compare the choroidal thickness in eyes of diabetic patients with eyes of age matched controls using optical coherence tomography.
Read the detailed description
Diabetic retinopathy (DR) is the most common and specific complication of DM. It is one of the leading causes of preventable blindness in the adult working population. (1) DR was the fifth leading cause of blindness and of moderate and severe vision impairment.
Global prevalence of diabetic retinopathy was 22.27% and prevalence was highest in Africa (35.90%). (1)
Fortunately, much of the visual loss from DR is preventable, and the rates of vision loss from diabetes and DR have declined over the past few decades due to advances in ocular disease assessment, screening, imaging and treatment in recent years. (2)
The outer third of the retina gets oxygen and nutrients from choroid. The three vascular layers of choroid are chorio capillaries layer, Sattler layer and Haller layer. (3)
A healthy choroid is essential for retinal function by continuous perfusion into the outer retina, which plays critical roles in thermoregulation of the retina, maintenance of the anatomic position of the retina, removal of residues, and secretion of growth factors. (4-5)
The vascular choroid changes of the diabetic patients are quite similar to those seen in DR, such as increased vascular tortuosity, vascular outpouchings, microaneurysms, nonperfusion areas, vascular dilations and narrowing, and choroidal neovascularization. (6)
Until recently, the choroid could only be evaluated by indocyanine green angiography, laser Doppler flowmetry, and ultrasonography. (6) Optical coherence tomography (OCT) is a non-invasive imaging modality, which is used in acquiring high-resolution sections of retina. (5)
- Conditions
- Choroid Disease, Diabetes Mellitus
- Being tested
- optical coherence tomography
- Medical subject headings
- Choroid Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optical coherence tomographyDevice
measuring choroidal thickness using optical coherence tomography
| Study group | Role | What they receive |
|---|---|---|
| diabetics | Type 2 DM patients aged 30 to 80 years Receives: Device: optical coherence tomography | |
| non diabetics | non-diabetic healthy individuals Receives: Device: optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison between choroidal thickness
To compare choroidal thickness using optical coherence tomography between eyes of healthy individuals and diabetic patients without retinopathy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start15 Mar 2024 (estimated)
- Primary completion30 Mar 2029 (estimated)
- Study completion15 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Choroid DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Basem Monier, Assiut University
- Investigators
- Mohammed Shehata Hussein, Study director, Assiut UniversityDalia Mohamed El-Sebaity, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272851
- Sponsor's protocol ID
- Choroidal thickness by OCT
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Teo ZL, Tham YC, Yu M, Chee ML, Rim TH, Cheung N, Bikbov MM, Wang YX, Tang Y, Lu Y, Wong IY, Ting DSW, Tan GSW, Jonas JB, Sabanayagam C, Wong TY, Cheng CY. Global Prevalence of Diabetic Retinopathy and Projection of Burden through 2045: Systematic Review and Meta-analysis. Ophthalmology. 2021 Nov;128(11):1580-1591. doi: 10.1016/j.ophtha.2021.04.027. Epub 2021 May 1.
PubMed 33940045Tan TE, Wong TY. Diabetic retinopathy: Looking forward to 2030. Front Endocrinol (Lausanne). 2023 Jan 9;13:1077669. doi: 10.3389/fendo.2022.1077669. eCollection 2022.
PubMed 36699020Hassan H, Cheema A, Tahir MA, Nawaz HN. Comparison of choroidal thickness in eyes of diabetic patients with eyes of healthy individuals using optical coherence tomography in a tertiary care hospital. Pak J Med Sci. 2022 Jan-Feb;38(1):254-260. doi: 10.12669/pjms.38.1.4443.
PubMed 35035435Endo H, Kase S, Saito M, Yokoi M, Takahashi M, Ishida S, Kase M. Choroidal Thickness in Diabetic Patients Without Diabetic Retinopathy: A Meta-analysis. Am J Ophthalmol. 2020 Oct;218:68-77. doi: 10.1016/j.ajo.2020.05.036. Epub 2020 Jun 20.
PubMed 32574782Regatieri CV, Branchini L, Carmody J, Fujimoto JG, Duker JS. Choroidal thickness in patients with diabetic retinopathy analyzed by spectral-domain optical coherence tomography. Retina. 2012 Mar;32(3):563-8. doi: 10.1097/IAE.0b013e31822f5678.
PubMed 22374157Tavares Ferreira J, Vicente A, Proenca R, Santos BO, Cunha JP, Alves M, Papoila AL, Abegao Pinto L. CHOROIDAL THICKNESS IN DIABETIC PATIENTS WITHOUT DIABETIC RETINOPATHY. Retina. 2018 Apr;38(4):795-804. doi: 10.1097/IAE.0000000000001582.
PubMed 28267113
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Choroidal Thickness Using Optical Coherence Tomography Between the Eyes of Healthy Individuals and Diabetic Patients Without Retinopathy
- ClinicalTrials.gov ID
- NCT06272851
- Acronym / sponsor ID
- Choroidal thickness by OCT
- Conditions
- Choroid Disease, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 15 May 2029 (estimated)
- First posted
- 22 Feb 2024 (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.
To compare the choroidal thickness in eyes of diabetic patients with eyes of age matched controls using optical coherence tomography.
Detailed description
Diabetic retinopathy (DR) is the most common and specific complication of DM. It is one of the leading causes of preventable blindness in the adult working population. (1) DR was the fifth leading cause of blindness and of moderate and severe vision impairment.
Global prevalence of diabetic retinopathy was 22.27% and prevalence was highest in Africa (35.90%). (1)
Fortunately, much of the visual loss from DR is preventable, and the rates of vision loss from diabetes and DR have declined over the past few decades due to advances in ocular disease assessment, screening, imaging and treatment in recent years. (2)
The outer third of the retina gets oxygen and nutrients from choroid. The three vascular layers of choroid are chorio capillaries layer, Sattler layer and Haller layer. (3)
A healthy choroid is essential for retinal function by continuous perfusion into the outer retina, which plays critical roles in thermoregulation of the retina, maintenance of the anatomic position of the retina, removal of residues, and secretion of growth factors. (4-5)
The vascular choroid changes of the diabetic patients are quite similar to those seen in DR, such as increased vascular tortuosity, vascular outpouchings, microaneurysms, nonperfusion areas, vascular dilations and narrowing, and choroidal neovascularization. (6)
Until recently, the choroid could only be evaluated by indocyanine green angiography, laser Doppler flowmetry, and ultrasonography. (6) Optical coherence tomography (OCT) is a non-invasive imaging modality, which is used in acquiring high-resolution sections of retina. (5)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetics | – | Device: optical coherence tomographyType 2 DM patients aged 30 to 80 years |
| non diabetics | – | Device: optical coherence tomographynon-diabetic healthy individuals |
Who may qualify
- Ages
- 30 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- known Type 2 DM patients aged 30 to 95 years either gender with no history of ocular treatment and non-diabetic healthy individuals who come to the hosoital
Key inclusion criteria (1 listed)
- All known Type 2 DM patients aged 30 to 95 years either gender who presented to ophthalmology clinics in Assuit ophthalmology hospital with no history of ocular treatment (ocular treatment naïve) and visual acuity of 0.1 (6/60) or more that are able to complete an eye examination, and non-diabetic healthy individuals (HbA1c <7) will be included in the study.
Key exclusion criteria (1 listed)
- Known diagnosis of any other retinal disease, glaucoma, neurodegenerative disease, and any significant media opacities that precluded fundus imaging and not giving consent will be excluded.
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 |
|---|---|---|
| optical coherence tomographymeasuring choroidal thickness using optical coherence tomography | Device | diabetics, non diabetics |
Primary outcome
comparison between choroidal thickness
Time frame: 2 years
To compare choroidal thickness using optical coherence tomography between eyes of healthy individuals and diabetic patients without retinopathy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Background: PubMed 33940045Teo ZL, Tham YC, Yu M, Chee ML, Rim TH, Cheung N, Bikbov MM, Wang YX, Tang Y, Lu Y, Wong IY, Ting DSW, Tan GSW, Jonas JB, Sabanayagam C, Wong TY, Cheng CY. Global Prevalence of Diabetic Retinopathy and Projection of Burden through 2045: Systematic Review and Meta-analysis. Ophthalmology. 2021 Nov;128(11):1580-1591. doi: 10.1016/j.ophtha.2021.04.027. Epub 2021 May 1.
- Background: PubMed 36699020Tan TE, Wong TY. Diabetic retinopathy: Looking forward to 2030. Front Endocrinol (Lausanne). 2023 Jan 9;13:1077669. doi: 10.3389/fendo.2022.1077669. eCollection 2022.
- Background: PubMed 35035435Hassan H, Cheema A, Tahir MA, Nawaz HN. Comparison of choroidal thickness in eyes of diabetic patients with eyes of healthy individuals using optical coherence tomography in a tertiary care hospital. Pak J Med Sci. 2022 Jan-Feb;38(1):254-260. doi: 10.12669/pjms.38.1.4443.
- Background: PubMed 32574782Endo H, Kase S, Saito M, Yokoi M, Takahashi M, Ishida S, Kase M. Choroidal Thickness in Diabetic Patients Without Diabetic Retinopathy: A Meta-analysis. Am J Ophthalmol. 2020 Oct;218:68-77. doi: 10.1016/j.ajo.2020.05.036. Epub 2020 Jun 20.
- Background: PubMed 22374157Regatieri CV, Branchini L, Carmody J, Fujimoto JG, Duker JS. Choroidal thickness in patients with diabetic retinopathy analyzed by spectral-domain optical coherence tomography. Retina. 2012 Mar;32(3):563-8. doi: 10.1097/IAE.0b013e31822f5678.
- Background: PubMed 28267113Tavares Ferreira J, Vicente A, Proenca R, Santos BO, Cunha JP, Alves M, Papoila AL, Abegao Pinto L. CHOROIDAL THICKNESS IN DIABETIC PATIENTS WITHOUT DIABETIC RETINOPATHY. Retina. 2018 Apr;38(4):795-804. doi: 10.1097/IAE.0000000000001582.
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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.
Mohammed Shehata Hussein study director
Assiut University
Dalia Mohamed El-Sebaity study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Choroid Disease and Diabetes Mellitus, run by Assiut University.
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 1 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: opening soon, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy Basem Monir (+201229159038, nancy.basem2010@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison between choroidal thickness (time frame: 2 years). 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 NCT06272851, which also lists 6 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 22 Feb 2024.