Thyroid Eye DiseaseNCT05241626
AS-OCT of the Cornea in Thyroid Diseases
An observational study of Thyroid Eye Disease, run by Minia University at 2 sites in Egypt.
Trial summary
use the anterior segment optical coherence tomography (AS-OCT) to evaluate the tear meniscus parameters, total corneal thickness (CT), and epithelial thickness in active and inactive thyroid eye diseases (TED) patients and compare them with age-matched controls. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Eye Disease
- What is being tested?
- AS-OCT
- How many people
- 70 participants
- Where
- 2 sitesEgypt
- Study dates
- 11 May 2021to 29 Oct 2022
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients were divided into 3 groups. Group 1 included 70 eyes of 35 patients of thyroid inactive disease, group 2 included 70 eyes of 35 patients of thyroid active disease, and group 3 included 70 eyes of 35 healthy controls
Who may be able to join
- The inclusion criteria were patients with thyroid disorders with age between 20 to 60 years with no ocular manifestations
Who cannot join
- being younger than 20 or older than 60, presence of systemic diseases as diabetes mellitus (DM) and autoimmune diseases as rheumatoid arthritis (RA) that may cause dry eye, previous ocular surgery, use of contact lenses, smokers, pregnant women, and breastfeeding women.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Anterior Segment Optical Coherence Tomography Study of the Tear Film and Cornea in Thyroid Eye Diseases.
use the anterior segment optical coherence tomography (AS-OCT) to evaluate the tear meniscus parameters, total corneal thickness (CT), and epithelial thickness in active and inactive thyroid eye diseases (TED) patients and compare them with age-matched controls.
Read the detailed description
A prospective case-control clinical study. The study subjects were divided into 3 groups, group 1 of inactive thyroid patients, group 2 of active thyroid patients, and group 3 of healthy controls. The AS-OCT was used to measure lower tear meniscus parameters (tear meniscus height (TMH), tear meniscus depth (TMD), and tear meniscus area (TMA)), total CT and epithelial thickness
- Conditions
- Thyroid Eye Disease
- Being tested
- AS-OCT
- Keywords
- Cornea- Tear film- AS-OCT
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AS-OCTDiagnostic test
Optical Coherence Tomography (OCT) creates detailed cross-sectional images of the anterior and posterior segments using low coherence interferometry. OCT is a noninvasive, real-time method for evaluating the tear meniscus, total corneal thickness (CT), and corneal epithelial thickness
| Study group | Role | What they receive |
|---|---|---|
| group 1 | 70 eyes of 35 patients of thyroid inactive disease Receives: Diagnostic Test: AS-OCT | |
| Group 2 | 70 eyes of 35 patients of thyroid active disease Receives: Diagnostic Test: AS-OCT | |
| Group 3 | Healthy controls Receives: Diagnostic Test: AS-OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Meniscus Height
represented by a line joining the points corresponding to the upper corneo-meniscus junction to the lower eyelid-meniscus junction
Measured: through study completion, an average of 6 months
Tear Meniscus Depth (TMD):
represented as the distance between the center of the upper boundary of the tear meniscus and the point at the bottom boundary where the cornea meets the eyelid
Measured: through study completion, an average of 6 months
Tear Meniscus Area (TMA)
triangular area formed by the corneal anterior boundary, anterior boundary of the lower eyelid and anterior borderline of the tear meniscus
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start11 May 2021
- Primary completion29 Oct 2022 (estimated)
- Study completion29 Oct 2022 (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 Minia 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah, Minia University
- Investigators
- mohamed Mahmoud, Principal investigator, Minia faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241626
- Sponsor's protocol ID
- 165-2021
- Status last verified
- Feb 2022
- First submitted
- 4 Feb 2022
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not to be shared
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Segment Optical Coherence Tomography Study of the Tear Film and Cornea in Thyroid Eye Diseases.
- ClinicalTrials.gov ID
- NCT05241626
- Acronym / sponsor ID
- 165-2021
- Conditions
- Thyroid Eye Disease
- Keywords
- Cornea- Tear film- AS-OCT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- 29 Oct 2022 (estimated)
- Study completion
- 29 Oct 2022 (estimated)
- First posted
- 16 Feb 2022 (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.
use the anterior segment optical coherence tomography (AS-OCT) to evaluate the tear meniscus parameters, total corneal thickness (CT), and epithelial thickness in active and inactive thyroid eye diseases (TED) patients and compare them with age-matched controls.
Detailed description
A prospective case-control clinical study. The study subjects were divided into 3 groups, group 1 of inactive thyroid patients, group 2 of active thyroid patients, and group 3 of healthy controls. The AS-OCT was used to measure lower tear meniscus parameters (tear meniscus height (TMH), tear meniscus depth (TMD), and tear meniscus area (TMA)), total CT and epithelial thickness
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Diagnostic Test: AS-OCT70 eyes of 35 patients of thyroid inactive disease |
| Group 2 | – | Diagnostic Test: AS-OCT70 eyes of 35 patients of thyroid active disease |
| Group 3 | – | Diagnostic Test: AS-OCTHealthy controls |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients were divided into 3 groups. Group 1 included 70 eyes of 35 patients of thyroid inactive disease, group 2 included 70 eyes of 35 patients of thyroid active disease, and group 3 included 70 eyes of 35 healthy controls
Key inclusion criteria (1 listed)
- The inclusion criteria were patients with thyroid disorders with age between 20 to 60 years with no ocular manifestations
Key exclusion criteria (1 listed)
- being younger than 20 or older than 60, presence of systemic diseases as diabetes mellitus (DM) and autoimmune diseases as rheumatoid arthritis (RA) that may cause dry eye, previous ocular surgery, use of contact lenses, smokers, pregnant women, and breastfeeding women.
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 |
|---|---|---|
| AS-OCTOptical Coherence Tomography (OCT) creates detailed cross-sectional images of the anterior and posterior segments using low coherence interferometry. OCT is a noninvasive, real-time method for evaluating the tear meniscus, total corneal thickness (CT), and corneal epithelial thickness | Diagnostic test | Group 2, Group 3, group 1 |
Primary outcome
Tear Meniscus Height
Time frame: through study completion, an average of 6 months
represented by a line joining the points corresponding to the upper corneo-meniscus junction to the lower eyelid-meniscus junction
Tear Meniscus Depth (TMD):
Time frame: through study completion, an average of 6 months
represented as the distance between the center of the upper boundary of the tear meniscus and the point at the bottom boundary where the cornea meets the eyelid
Tear Meniscus Area (TMA)
Time frame: through study completion, an average of 6 months
triangular area formed by the corneal anterior boundary, anterior boundary of the lower eyelid and anterior borderline of the tear meniscus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Individual participant dataSharing planned: No. IPD will not to be shared
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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.
mohamed Mahmoud principal investigator
Minia faculty of medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Eye Disease, run by Minia University at 2 sites in Egypt.
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 1 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 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear Meniscus Height (time frame: through study completion, an average of 6 months). The study lists 3 primary outcomes in all. 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 16 Feb 2022.