NCT04752969

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 12, 2021

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

7 months

First QC Date

January 31, 2021

Last Update Submit

February 12, 2021

Conditions

Keywords

Thyroid disorderCorneal opacityCorneal aberrations

Outcome Measures

Primary Outcomes (1)

  • corneal density in throid patients

    corneal density values according to type of thyroid disorder

    up to 12 weeks

Study Arms (3)

Hypothyroidia

20 subjects diagnosed with hypothyroidism

Hyperthyroidia

20 subjects diagnosed with hyperthyroidism

Healthy

20 age-matched healthy control subjects

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sağlık Bilimleri Üniversitesi Gazi Yaşargil Training and Research Hospital

Diyarbakır, 211100, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Thyroid DiseasesCorneal Opacity

Condition Hierarchy (Ancestors)

Endocrine System DiseasesCorneal DiseasesEye Diseases

Study Officials

  • Mehmet F Alakuş, MD

    Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

January 31, 2021

First Posted

February 12, 2021

Study Start

June 15, 2020

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

February 16, 2021

Record last verified: 2021-02

Locations