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

NCT ID: NCT06235372

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-21
• Study Completion Date: 2025-12-22

Brief Summary

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

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

Conditions

Thyroid Eye Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

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 .

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mayar Ashraf Mohamed

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dalia Mohammed, Professor

Role: STUDY_DIRECTOR

Academic organizations

Khaled Abdelazim, Assistant professor

Role: STUDY_DIRECTOR

Academic organizations

Ahmed Abdelnasser, Lecturer

Role: STUDY_DIRECTOR

Academic organizations

Central Contacts

Mayar Ashraf, Resident

Role: CONTACT

mayarahrafs7777@gmail.com

+201024240738

Other Identifiers

Specular microscopy in TED

Identifier Type: -

Identifier Source: org_study_id