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CompletedNCT04752969Updated Feb 16, 2021

The Effect of Thyroid Hormon Levels on the Corneal Measures

An observational study in Thyroid Disorder and Corneal Opacity, sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-16.

Sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
60
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Thyroid Disorder
  • Corneal Opacity

Keywords

  • Thyroid disorder
  • Corneal opacity
  • Corneal aberrations
03

In context

Thyroid Diseases

365 studies on the registry are indexed under Thyroid Diseases; 80 are open to participants now.

This study's enrollment of 60 is below the median of 198 across 158 observational studies indexed under Thyroid Diseases.

Browse Thyroid Diseases studies →

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital is the lead sponsor of 59 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

20 patients diagnosed hypthyroidia ,20 patients diagnosed hyperthyroidia ,20 age matched healthy individuals

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • Hypothyroidia

    20 subjects diagnosed with hypothyroidism

  • Hyperthyroidia

    20 subjects diagnosed with hyperthyroidism

  • Healthy

    20 age-matched healthy control subjects

06

What researchers measure

Primary outcomes

  1. corneal density in throid patients

    corneal density values according to type of thyroid disorder

    Time frame: up to 12 weeks

07

Study locations

1 site
  • Sağlık Bilimleri Üniversitesi Gazi Yaşargil Training and Research Hospital
    Diyarbakır, 211100, Turkey
08

References and documents

Publications

  • 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. doi: 10.1007/s00417-019-04593-8. Epub 2020 Jan 8. PubMed 31915973 ↗
  • 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. PubMed 21705880 ↗
  • Villani E, Viola F, Sala R, Salvi M, Mapelli C, Curro 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 Apr 30. PubMed 20435595 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2020 to primary completion in Jan 2021, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 31, 2021
First posted
Feb 12, 2021
StartActual
Jun 15, 2020
Primary completionActual
Jan 1, 2021
CompletionActual
Jan 1, 2021
Last update
Feb 16, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04752969
Lead sponsor
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Responsible party
Mehmet Fuat Alakuş (assistant professor, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital) — Principal investigator
First posted
Feb 12, 2021
Start date
Jun 15, 2020
Primary completion
Jan 1, 2021
Completion
Jan 1, 2021
Last update
Feb 16, 2021

Study contacts

Mehmet F Alakuş, MD
principal investigator · Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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