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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04752969
Other study ID # 30012021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 15, 2020
Est. completion date January 1, 2021

Study information

Verified date February 2021
Source Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 III) have been recruited. The Pentacam high resolution imaging system is used to determine corneal topographic measurements,aberrometry and densitometry.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Saglik Bilimleri Üniversitesi Gazi Yasargil Training and Research Hospital Diyarbakir

Sponsors (1)

Lead Sponsor Collaborator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Bilgihan K, Hondur A, Sul S, Ozturk S. Pregnancy-induced progression of keratoconus. Cornea. 2011 Sep;30(9):991-4. doi: 10.1097/ICO.0b013e3182068adc. — View Citation

Cankurtaran V, Tekin K, Cakmak AI, Inanc M, Turgut FH. Assessment of corneal topographic, tomographic, densitometric, and biomechanical properties of Fabry patients with ocular manifestations. Graefes Arch Clin Exp Ophthalmol. 2020 May;258(5):1057-1064. d — View Citation

Villani E, Viola F, Sala R, Salvi M, Mapelli C, Currò N, Vannucchi G, Beck-Peccoz P, Ratiglia R. Corneal involvement in Graves' orbitopathy: an in vivo confocal study. Invest Ophthalmol Vis Sci. 2010 Sep;51(9):4574-8. doi: 10.1167/iovs.10-5380. Epub 2010 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary corneal density in throid patients corneal density values according to type of thyroid disorder up to 12 weeks
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