Measuring Choroidal Thickness Using Optical Coherence Tomography

NCT06272851 | Not Yet Recruiting

• 1 other identifier: Choroidal thickness by OCT
• Study Type: observational
• Target: 122
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Choroid Disease; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• comparison between choroidal thickness

  To compare choroidal thickness using optical coherence tomography between eyes of healthy individuals and diabetic patients without retinopathy

  2 years

Study Arms (2)

diabetics

Type 2 DM patients aged 30 to 80 years

Device: optical coherence tomography

non diabetics

non-diabetic healthy individuals

Device: optical coherence tomography

Interventions

optical coherence tomography DEVICE

measuring choroidal thickness using optical coherence tomography

diabetics; non diabetics

Eligibility Criteria

• Age: 30 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• 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.

  PMID: 33940045 BACKGROUND

• 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.

  PMID: 36699020 BACKGROUND

• 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.

  PMID: 35035435 BACKGROUND

• 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.

  PMID: 32574782 BACKGROUND

• 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.

  PMID: 22374157 BACKGROUND

• 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.

  PMID: 28267113 BACKGROUND

MeSH Terms

Conditions

Choroid Diseases; Diabetes Mellitus

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Mohammed Shehata Hussein

  Assiut University

  STUDY DIRECTOR

• Dalia Mohamed El-Sebaity

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Nancy Basem Monir

CONTACT

+201229159038; nancy.basem2010@gmail.com

Islam Mohamed Gouda

CONTACT

+201061882554; Islamgoda@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NBMonier

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: March 15, 2024
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): May 15, 2029
• Last Updated: February 22, 2024

Record last verified: 2024-02