Corneal Tomographic Parameters in TGD

Sponsor

Ameera Gamal Abdelhameed (Other)

Overall Status

Completed

CT.gov ID

NCT04433936

Collaborator

(none)

100

Enrollment

Location

3.9

Actual Duration (Months)

25.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The current study involved analysis of the corneal tomographic parameters of patients with thyroid gland dysfunction (hyperthyroidism or hypothyroidism), including those with an autoimmune etiology, in comparison to healthy controls without TGD, using pentacam, in an attempt to detect possible early corneal changes and to highlight whether early screening of those patients would be necessary for early detection of KC.

Condition or Disease	Intervention/Treatment	Phase
Keratoconus Corneal Ectasia Thyroid Eye Disease	Diagnostic Test: Pentacam tomography

Detailed Description

A total of 100 eyes of 50 patients with TGD and 100 eyes of 50 healthy controls were enrolled. Diagnosis of TGD was based on history, clinical examination and laboratory investigations. Exclusion criteria included previous thyroid medications, thyroidectomy, previous ocular surgery, corneal pathology and other risk factors of keratoconus (KC). All eyes were examined by Pentacam, (Oculus Optikgerate GmbH, Wetzlar, Germany). Pentacam parameters were compared between TGD patients and controls. Spearman's correlation coefficient between different pentacam parameters and the level of free T4 and TSH was calculated.

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Corneal Tomographic Analysis Among Patients With Thyroid Gland Dysfunction.

Actual Study Start Date :

Feb 1, 2018

Actual Primary Completion Date :

Jun 1, 2018

Actual Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Thyroid Gland Dysfunction Patients with a recent diagnosis of TGD (the study group) were recruited from endocrinology outpatient clinic of Specialized Medical Hospital, Mansoura University. Diagnosis of TGD was based on précised history, clinical examination and laboratory investigations. In order to avoid bias, patients with history of intake of any thyroid-related medications (antithyroid medications or thyroxine replacement), radioactive iodine or thyroidectomy were excluded from the study.	Diagnostic Test: Pentacam tomography The Pentacam maps were analyzed. The following anterior and posterior corneal surface parameters were evaluated by the Scheimpflug system: Kf, Ks, Kmax. The pachymetric map was analyzed, including CCT at the apex of the geometric center and CTmin. PPIavg, PPI min and PPI max were calculated . The Ambrósio relational thickness (ART) was calculated The posterior corneal elevation maps were evaluated and the posterior corneal elevation values relative to this reference were recorded. The back difference elevation and multimetric D index values were extrapolated from the difference map of the Belin/Ambrósio-enhanced ectasia display of the Pentacam system.
Control fifty age and gender matched healthy subjects without known personal or family history of thyroid disease or any autoimmune diseases were recruited from candidates of refractive surgery referred to the outpatient clinic of Mansoura Ophthalmology Center for pentacam assessment and who were proved to have normal corneal pentacam parameters. They were further examined by the endocrinologist to exclude thyroid dysfunction; this was supported by normal thyroid function profile (serum TSH and free T4) and negative anti-TPO and antithyroglobulin antibodies.	Diagnostic Test: Pentacam tomography The Pentacam maps were analyzed. The following anterior and posterior corneal surface parameters were evaluated by the Scheimpflug system: Kf, Ks, Kmax. The pachymetric map was analyzed, including CCT at the apex of the geometric center and CTmin. PPIavg, PPI min and PPI max were calculated . The Ambrósio relational thickness (ART) was calculated The posterior corneal elevation maps were evaluated and the posterior corneal elevation values relative to this reference were recorded. The back difference elevation and multimetric D index values were extrapolated from the difference map of the Belin/Ambrósio-enhanced ectasia display of the Pentacam system.

Arm

Intervention/Treatment

Thyroid Gland Dysfunction

Patients with a recent diagnosis of TGD (the study group) were recruited from endocrinology outpatient clinic of Specialized Medical Hospital, Mansoura University. Diagnosis of TGD was based on précised history, clinical examination and laboratory investigations. In order to avoid bias, patients with history of intake of any thyroid-related medications (antithyroid medications or thyroxine replacement), radioactive iodine or thyroidectomy were excluded from the study.

Diagnostic Test: Pentacam tomography

The Pentacam maps were analyzed. The following anterior and posterior corneal surface parameters were evaluated by the Scheimpflug system: Kf, Ks, Kmax. The pachymetric map was analyzed, including CCT at the apex of the geometric center and CTmin. PPIavg, PPI min and PPI max were calculated . The Ambrósio relational thickness (ART) was calculated The posterior corneal elevation maps were evaluated and the posterior corneal elevation values relative to this reference were recorded. The back difference elevation and multimetric D index values were extrapolated from the difference map of the Belin/Ambrósio-enhanced ectasia display of the Pentacam system.

Control

fifty age and gender matched healthy subjects without known personal or family history of thyroid disease or any autoimmune diseases were recruited from candidates of refractive surgery referred to the outpatient clinic of Mansoura Ophthalmology Center for pentacam assessment and who were proved to have normal corneal pentacam parameters. They were further examined by the endocrinologist to exclude thyroid dysfunction; this was supported by normal thyroid function profile (serum TSH and free T4) and negative anti-TPO and antithyroglobulin antibodies.

Diagnostic Test: Pentacam tomography

Outcome Measures

Primary Outcome Measures

corneal tomographic parameter [1 day (once at first recruitment)]
analysis of pentacam maps

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

For TGD patients: Patients with a recent diagnosis of TGD (the study group) were recruited from endocrinology outpatient clinic of Specialized Medical Hospital, Mansoura University. Diagnosis of TGD was based on précised history, clinical examination and laboratory investigations. In order to avoid bias, patients with history of intake of any thyroid-related medications (antithyroid medications or thyroxine replacement), radioactive iodine or thyroidectomy were excluded from the study. Therefore, we only included patients who did not received treatment yet For the control group, fifty age and gender matched healthy subjects without known personal or family history of thyroid disease or any autoimmune diseases were recruited from candidates of refractive surgery referred to the outpatient clinic of Mansoura Ophthalmology Center for pentacam assessment and who were proved to have normal corneal pentacam parameters. They were further examined by the endocrinologist to exclude thyroid dysfunction; this was supported by normal thyroid function profile (serum TSH and free T4) and negative anti-TPO and antithyroglobulin antibodies.

Exclusion Criteria:

patients with previous thyroid medications or replacement therapy, thyroidectomy or radioactive iodine intake participants with a history of ocular surgery or trauma, use of any topical medication or contact lens wear, patients with any corneal pathology, Corneal dystrophy, corneal scarring or any concurrent ocular disease. To eliminate other risk factors for KC, we also excluded participants with a history of persistent eye rubbing, vernal keratoconjunctivitis (VKC), atopy, Down syndrome, Turner's syndrome, or congenital rubella. Pregnant or lactating females were also excluded from the study.