AS-OCT of the Cornea in Thyroid Diseases

February 14, 2022 updated by: Mohamed Salah, Minia University

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt
        • Minia University Hospital
      • Minya, Egypt
        • Minia faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group 1
70 eyes of 35 patients of thyroid inactive disease
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
Group 2
70 eyes of 35 patients of thyroid active disease
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
Group 3
Healthy controls
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 6 months
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
through study completion, an average of 6 months
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
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Investigators

  • Principal Investigator: mohamed Mahmoud, Minia faculty of medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2021

Primary Completion (Anticipated)

October 29, 2022

Study Completion (Anticipated)

October 29, 2022

Study Registration Dates

First Submitted

February 4, 2022

First Submitted That Met QC Criteria

February 14, 2022

First Posted (Actual)

February 16, 2022

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 165-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD will not to be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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