Evaluation of the Corneal Endothelial Cell Layer by Specular Microscopy in Patients With Thyroid Eye Disease

March 19, 2024 updated by: Mayar Ashraf Mohamed, Assiut University
To investigate corneal endothelial cell layer damage by specular microscopy in patients with thyroid eye disease

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Thyroid eye disease is a common periorbital autoimmune inflammatory disease .It significantly impairs quality of the life ,causes cosmetic defects ,and could be sight-threatening ,especially when optic nerve or the cornea is affected.Classic manifestations of thyroid eye disease include proptosis ,lid retraction ,lagophthalmos,optic neuropathy and restrictive extraocular myopathy.In addition to the affection of the orbital and lacrimal glands ,the corneal endothelium has showen morphological changes in patients with thyroid eye disease .corneal endothelium is the innermost corneal layer facing the anterior chamber and is known for maintaining corneal transparency by its pump-leak function .corneal transparency is crucial for optimal vision . severe damage to corneal endothelium can induce corneal opacification .resulting in corneal edema and subsequently vision loss. That is because there are thyroxine receptors in all layers of the conea. And the autoantibodies to TSH receptors usually attach to them causing damage to the cornea.Specular microscopy is one of the best investigative procedure used to assess changes in the corneal endothelium due to thyroid eye disease.Specular microscopy is a noninvasive photographic technique that analyze the corneal endothelium. Using computer-assisted morphometry, modern specular microscopes analyze the characteristics of the endothelial cells. The instrument projects light onto the cornea and captures the image that is reflected from the optical interface between the corneal endothelium and the aqueous humor. The reflected image is analyzed by the instrument and displayed as a specular photomicrograph

Study Type

Observational

Enrollment (Estimated)

30

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with thyroid eye disease whom diagnosis was established based on bartley diagnostic criteria .

Description

Inclusion Criteria:

  • Patients with thyroid eye disease whom diagnosis was established based on bartley diagnostic criteria .

Exclusion Criteria:

  • participates with systemic diseases other than HT such as

    1. diabetes mellitus
    2. previous ocular surgery or laser therapy.
    3. history of corneal disease.
    4. history of trauma.
    5. history of glaucoma

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Damage of the corneal endothelial cells in patients with thyroid eye disease by specular microscopy
Time Frame: Baseline
To detect if there is any change in corneal endothelial cell layer in patients with thyroid eye disease
Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Dalia Mohammed, Professor, Academic organizations
  • Study Director: Khaled Abdelazim, Assistant professor, Academic organizations
  • Study Director: Ahmed Abdelnasser, Lecturer, Academic organizations

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 21, 2024

Primary Completion (Estimated)

October 22, 2025

Study Completion (Estimated)

December 22, 2025

Study Registration Dates

First Submitted

December 22, 2023

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Specular microscopy in TED

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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