Measuring Choroidal Thickness Using Optical Coherence Tomography

February 15, 2024 updated by: Nancy Basem Monier, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
diabetics
Type 2 DM patients aged 30 to 80 years
Device: optical coherence tomography
measuring choroidal thickness using optical coherence tomography
non diabetics
non-diabetic healthy individuals
Device: optical coherence tomography
measuring choroidal thickness using optical coherence tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Mohammed Shehata Hussein, Assiut University
  • Study Director: Dalia Mohamed El-Sebaity, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2024

Primary Completion (Estimated)

March 30, 2029

Study Completion (Estimated)

May 15, 2029

Study Registration Dates

First Submitted

February 15, 2024

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Estimated)

February 22, 2024

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Choroidal thickness by OCT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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