The Effect of Thyroid Hormon Levels on the Corneal Measures | NCT04752969

Studies
The Effect of Thyroid Hormon Levels on the Corneal Measures

NCT04752969

Sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Status

Completed

Last Update Posted

Feb 16, 2021Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Thyroid Disorder
Corneal Opacity

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2020Actual

Primary Completion Date

Jan 1, 2021Actual

Completion Date

Jan 1, 2021Actual

First Submitted Date

Jan 31, 2021

First Submission Date that Met QC Criteria

Feb 10, 2021

First Posted Date

Feb 12, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2021

Last Update Posted Date

Feb 16, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mehmet Fuat Alakuş, assistant professor, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalPrincipal Investigator

Lead Sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypothyroidia		20 subjects diagnosed with hypothyroidism
Hyperthyroidia		20 subjects diagnosed with hyperthyroidism
Healthy		20 age-matched healthy control subjects

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
corneal density in throid patients	corneal density values according to type of thyroid disorder	up to 12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mehmet F Alakuş, MD	Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sağlık Bilimleri Üniversitesi Gazi Yaşargil Training and Research Hospital		Diyarbakır		211100	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31915973	Result	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.
21705880	Result

ID	Term
D013959	Thyroid Diseases
D003318	Corneal Opacity

ID	Term
D004700	Endocrine System Diseases
D003316	Corneal Diseases
D005128	Eye Diseases