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The Effect of Thyroid Hormon Levels on the Corneal Measures

Sponsor
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04752969
Collaborator
(none)
60
Enrollment
1
Location
6.6
Actual Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this cross-sectional comparative study, it is aimed to investigate the topographic measurements,aberrometrics and densitometrics values of corneas in hypothyroid and hyperthyroid patients compared to healthy individuals. A number of 20 hypothyroid patients (group I), 20 hyperthyroid patients (group II), and 20 age-matched healthy controls (group

  1. have been recruited. The Pentacam high resolution imaging system is used to determine corneal topographic measurements,aberrometry and densitometry.
Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Thyroid hormone diseases can cause different symptoms and signs in the body according to the hormone levels, particularly in the eyes. Corneal tissue can be affected by many biochemical and hormonal factors, and many ocular surface and systemic diseases can affect the cornea.Hyperthyroidism has been shown to cause symptoms such as conjunctival chemosis, proptosis, increased intraocular pressure, limitation to globe movements due to the restriction of extraocular muscles, increased orbital volume, increased risk of glaucoma with inflammation in the trabecular meshwork and exposure keratopathy, especially in Graves' disease. In the case of hypothyroidism, studies have shown fluid retention and edema in all body tissues, thereby resulting in increased thickness in the cornea, as well as a decrease in corneal hysteresis, which increases the risk of glaucoma. In this study, it is aimed to assess whether thyroid hormone changes affect those parameters by objectively measuring corneal changes via corneal topography, corneal densitometry and corneal aberrometry.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Can Thyroid Levels Affect Topographic, Densitometric and Aberrometric Values of the Cornea
    Actual Study Start Date :
    Jun 15, 2020
    Actual Primary Completion Date :
    Jan 1, 2021
    Actual Study Completion Date :
    Jan 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Hypothyroidia

    20 subjects diagnosed with hypothyroidism
    Hyperthyroidia

    20 subjects diagnosed with hyperthyroidism
    Healthy

    20 age-matched healthy control subjects

    Outcome Measures

    Primary Outcome Measures

    1. corneal density in throid patients [up to 12 weeks]

      corneal density values according to type of thyroid disorder

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Thyroid hormone disorder patients with a novel diagnosis

    • Age-matched healthy individuals without any systemic disorder (e.g., diabetes mellitus, hypertension, rhematoid artritis, asthma etc.)

    Exclusion Criteria:

    • Having a spherical or cylindrical refractive error of >1.0 degrees,

    • Congenital corneal dystrophies, corneal ectasia, corneal ulcers or scars, keratitis, ocular surface infections, keratoconus,

    • A history of ocular trauma,

    • Uveitis,

    • Glaucoma,

    • A history of contact lens wear,

    • A history of ocular surgery,

    • Dry eye diseases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sağlık Bilimleri Üniversitesi Gazi Yaşargil Training and Research Hospital Diyarbakır Turkey 211100

    Sponsors and Collaborators

    • Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

    Investigators

    • Principal Investigator: Mehmet F Alakuş, MD, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mehmet Fuat Alakuş, assistant professor, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT04752969
    Other Study ID Numbers:
    • 30012021
    First Posted:
    Feb 12, 2021
    Last Update Posted:
    Feb 16, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mehmet Fuat Alakuş, assistant professor, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
    Thyroid disorder
    Corneal opacity
    Corneal aberrations
    Additional relevant MeSH terms:
    Corneal Opacity
    Thyroid Diseases

    Study Results

    No Results Posted as of Feb 16, 2021