Measuring Choroidal Thickness Using Optical Coherence Tomography

NCT ID: NCT06272851

Last Updated: 2024-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-15

Study Completion Date

2029-05-15

Brief Summary

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To compare the choroidal thickness in eyes of diabetic patients with eyes of age matched controls using optical coherence tomography.

Detailed Description

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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

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Choroid Disease Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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diabetics

Type 2 DM patients aged 30 to 80 years

optical coherence tomography

Intervention Type DEVICE

measuring choroidal thickness using optical coherence tomography

non diabetics

non-diabetic healthy individuals

optical coherence tomography

Intervention Type DEVICE

measuring choroidal thickness using optical coherence tomography

Interventions

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optical coherence tomography

measuring choroidal thickness using optical coherence tomography

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Nancy Basem Monier

NBMonier

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammed Shehata Hussein

Role: STUDY_DIRECTOR

Assiut University

Dalia Mohamed El-Sebaity

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Nancy Basem Monir

Role: CONTACT

+201229159038

Islam Mohamed Gouda

Role: CONTACT

+201061882554

References

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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.

Reference Type BACKGROUND
PMID: 33940045 (View on PubMed)

Tan 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.

Reference Type BACKGROUND
PMID: 36699020 (View on PubMed)

Hassan 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.

Reference Type BACKGROUND
PMID: 35035435 (View on PubMed)

Endo 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.

Reference Type BACKGROUND
PMID: 32574782 (View on PubMed)

Regatieri 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.

Reference Type BACKGROUND
PMID: 22374157 (View on PubMed)

Tavares 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.

Reference Type BACKGROUND
PMID: 28267113 (View on PubMed)

Other Identifiers

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Choroidal thickness by OCT

Identifier Type: -

Identifier Source: org_study_id

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