AS-OCT of the Cornea in Thyroid Diseases

Sponsor
Minia University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05241626
Collaborator
(none)
70
2
17.6
35
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: AS-OCT

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 Design

Study Type:
Observational
Anticipated Enrollment :
70 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Anterior Segment Optical Coherence Tomography Study of the Tear Film and Cornea in Thyroid Eye Diseases.
Actual Study Start Date :
May 11, 2021
Anticipated Primary Completion Date :
Oct 29, 2022
Anticipated Study Completion Date :
Oct 29, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Minia Faculty of medicine Minya Egypt
2 Minia University hospital Minya Egypt

Sponsors and Collaborators

  • Minia University

Investigators

  • Principal Investigator: mohamed Mahmoud, Minia faculty of medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Salah, Dr Mohamed Salah, Minia University
ClinicalTrials.gov Identifier:
NCT05241626
Other Study ID Numbers:
  • 165-2021
First Posted:
Feb 16, 2022
Last Update Posted:
Feb 16, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mohamed Salah, Dr Mohamed Salah, Minia University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2022