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Clinical Trials/NCT05241626
NCT05241626
Unknown
Not Applicable

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

Minia University2 sites in 1 country70 target enrollmentMay 11, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thyroid Eye Disease
Sponsor
Minia University
Enrollment
70
Locations
2
Primary Endpoint
Tear Meniscus Depth (TMD):
Last Updated
4 years ago

Overview

Brief 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.

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

Registry
clinicaltrials.gov
Start Date
May 11, 2021
End Date
October 29, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Minia University
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Salah

Dr Mohamed Salah

Minia University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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 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 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

Study Sites (2)

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