Clinical trial NCT06235372: Evaluation of the Corneal Endothelial Cell Layer by Specular Microscopy in Patients With Thyroid Eye Disease
Official title: Evaluation of the Corneal Endothelial Cell Layer by Specular Microscopy in Patients With Thyroid Eye Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Thyroid Eye Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with thyroid eye disease whom diagnosis was established based on bartley diagnostic criteria .

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

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

Primary outcomes:
measure: Damage of the corneal endothelial cells in patients with thyroid eye disease by specular microscopy
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Academic organizations
name: Dalia Mohammed, Professor
role: STUDY_DIRECTOR
affiliation: Academic organizations
name: Khaled Abdelazim, Assistant professor
role: STUDY_DIRECTOR
affiliation: Academic organizations
name: Ahmed Abdelnasser, Lecturer
role: STUDY_DIRECTOR
References: