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NCT05241626 Clinical Trial

AS-OCT of the Cornea in Thyroid Diseases

Thyroid Eye Disease Clinical Trial

Official title:
Anterior Segment Optical Coherence Tomography Study of the Tear Film and Cornea in Thyroid Eye Diseases.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05241626
Other study ID # 165-2021
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 11, 2021
Est. completion date October 29, 2022

Study information
Verified date February 2022
Source Minia University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 70
Est. completion date October 29, 2022
Est. primary completion date October 29, 2022
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - The inclusion criteria were patients with thyroid disorders with age between 20 to 60 years with no ocular manifestations Exclusion Criteria: - 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• AS-OCT
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

Locations
Country Name City State
Egypt Minia Faculty of medicine Minya
Egypt Minia University hospital Minya

Sponsors (1)
Lead Sponsor Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tear Meniscus Height represented by a line joining the points corresponding to the upper corneo-meniscus junction to the lower eyelid-meniscus junction through study completion, an average of 6 months
Primary 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 through study completion, an average of 6 months
Primary 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 through study completion, an average of 6 months
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