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NCT06235372 Clinical Trial

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

Thyroid Eye Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06235372
Other study ID # Specular microscopy in TED
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 21, 2024
Est. completion date December 22, 2025

Study information
Verified date January 2024
Source Assiut University
Contact Mayar Ashraf, Resident
Phone +201024240738
Email mayarahrafs7777@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To investigate corneal endothelial cell layer damage by specular microscopy in patients with thyroid eye disease

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date December 22, 2025
Est. primary completion date October 22, 2025
Accepts healthy volunteers
Gender All
Age group 12 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Specular microscopy
Specular microscopy is a noninvasive photographic technique that analyze the corneal endothelium. Using computer-assisted morphometry, modern specular microscopes analyze the size, shape and population 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 .

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

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