Thyroid Eye DiseaseNCT06235372
Evaluation of the Corneal Endothelial Cell Layer by Specular Microscopy in Patients With Thyroid Eye Disease
An observational study of Thyroid Eye Disease, run by Assiut University.
Trial summary
To investigate corneal endothelial cell layer damage by specular microscopy in patients with thyroid eye disease Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Thyroid Eye Disease
- What is being tested?
- Specular microscopy
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 21 Mar 2024to 22 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- Child, Adult, Older adult
Study population: Patients with thyroid eye disease whom diagnosis was established based on bartley diagnostic criteria .
Who may be able to join
- Patients with thyroid eye disease whom diagnosis was established based on bartley diagnostic criteria .
Who cannot join
- participates with systemic diseases other than HT such as
- diabetes mellitus
- previous ocular surgery or laser therapy.
- history of corneal disease.
- history of trauma.
- history of glaucoma
Trial locations and contacts
No sites are listed yet.
About this study
To investigate corneal endothelial cell layer damage by specular microscopy in patients with thyroid eye disease
Read the 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
- Being tested
- Specular microscopy
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specular microscopyDevice
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 .
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start21 Mar 2024 (estimated)
- Primary completion22 Oct 2025 (estimated)
- Study completion22 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayar Ashraf Mohamed, Assiut University
- Investigators
- Dalia Mohammed, Professor, Study director, Academic organizationsKhaled Abdelazim, Assistant professor, Study director, Academic organizationsAhmed Abdelnasser, Lecturer, Study director, Academic organizations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235372
- Sponsor's protocol ID
- Specular microscopy in TED
- Status last verified
- Jan 2024
- First submitted
- 22 Dec 2023
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Corneal Endothelial Cell Layer by Specular Microscopy in Patients With Thyroid Eye Disease
- ClinicalTrials.gov ID
- NCT06235372
- Acronym / sponsor ID
- Specular microscopy in TED
- Conditions
- Thyroid Eye Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 21 Mar 2024 (estimated)
- Primary completion
- 22 Oct 2025 (estimated)
- Study completion
- 22 Dec 2025 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with thyroid eye disease whom diagnosis was established based on bartley diagnostic criteria .
Key inclusion criteria (1 listed)
- Patients with thyroid eye disease whom diagnosis was established based on bartley diagnostic criteria .
Key exclusion criteria (6 listed)
- participates with systemic diseases other than HT such as
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specular microscopySpecular 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 . | Device | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalia Mohammed, Professor study director
Academic organizations
Khaled Abdelazim, Assistant professor study director
Academic organizations
Ahmed Abdelnasser, Lecturer study director
Academic organizations
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Eye Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mayar Ashraf, Resident (+201024240738, mayarahrafs7777@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Damage of the corneal endothelial cells in patients with thyroid eye disease by specular microscopy (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.