AS-OCT of the Cornea in Thyroid Diseases

• Conditions: Thyroid Eye Disease
• Interventions: Diagnostic Test: AS-OCT

• Registration Number: NCT05241626
• Lead Sponsor: Minia University

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

Study Timeline

• Study Start: 2021-05-11
• Status Verified: 2022-02
• Study First Submitted: 2022-02-04
• Study First Submitted QC: 2022-02-14
• Last Update Submitted: 2022-02-14
• Study First Posted: 2022-02-16
• Last Update Posted: 2022-02-16
• Primary Completion: 2022-10-29
• Study Completion: 2022-10-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group 1	AS-OCT	70 eyes of 35 patients of thyroid inactive disease
Group 2	AS-OCT	70 eyes of 35 patients of thyroid active disease
Group 3	AS-OCT	Healthy controls

Primary Outcome Measures

Name	Time	Method
Tear Meniscus Depth (TMD):	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	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)	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

Trial Locations

Locations (2)

Minia Faculty of medicine; 🇪🇬 Minya, Egypt

Minia University hospital; 🇪🇬 Minya, Egypt