AS-OCT of the Cornea in Thyroid Diseases

NCT05241626 | Unknown

• 1 other identifier: 165-2021
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Thyroid Eye Disease

Keywords

Cornea- Tear film- AS-OCT

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

group 1

70 eyes of 35 patients of thyroid inactive disease

Diagnostic Test: AS-OCT

Group 2

70 eyes of 35 patients of thyroid active disease

Diagnostic Test: AS-OCT

Group 3

Healthy controls

Diagnostic Test: AS-OCT

Interventions

AS-OCT DIAGNOSTIC_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

Group 2; Group 3; group 1

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (2)

Minia Faculty of medicine

Minya, Egypt

Location

Minia University hospital

Minya, Egypt

Location

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Officials

• mohamed Mahmoud

  Minia faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Mohamed Salah

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 16, 2022
• Study Start: May 11, 2021
• Primary Completion: October 29, 2022
• Study Completion: October 29, 2022
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)