- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03637673
The Possible Role of Thyroxine in Keratoconus Development
August 16, 2018 updated by: Amir abou Samra, Alexandria University
Keratoconus (KC) is a corneal ectatic disorders, with incidence rate 1 per 50,000 among the population.
Hormonal imbalances may be associated with KC as it affects the corneal metabolism.
In this study, we aim to examine this clinical association between thyroid gland dysfunction (TGD) and KC.
Study Overview
Detailed Description
Keratoconus (KC) is a corneal ectatic disorders, with incidence rate 1 per 50,000 among the population.
Moreover, the pathophysiological processes underlying KC have not been fully elucidated with proposed mechanisms to include proteolytic degradation in the corneal stroma, oxidative damage, epithelial mechanical injury, immunological factors, and genetic factors.
However, Hormonal imbalances may be associated with KC as it affects the corneal metabolism.
Furthermore, thyroid gland dysfunction (TGD) can frequently associated with eye diseases such as Graves disease.
Previous studies investigated the association between TGD and KC.
Interestingly, thyroxine (T4) is important for corneal dehydration and transparency during embryonic development and regulates the synthesis of keratin sulfate proteoglycan in the chicken.
T4 receptors (T4Rs) have been found in the lacrimal gland, confirming that the tear producing gland is a target organ of T4.
T4 level was elevated in the tears of patients with KC.
Hence, in this study, we aim to investigate the clinical association between TGD and KC.
Study Type
Observational
Enrollment (Anticipated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amir Abousamra, Ph.D.
- Phone Number: 00201005084303
- Email: amirabousamra69@gmail.com
Study Contact Backup
- Name: Mohamed Fahmy Doheim
- Phone Number: 001221081590
- Email: fahmydehim21@gmail.com
Study Locations
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Alexandria, Egypt
- Recruiting
- Alexandria Faculty of Medicine
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Contact:
- Amir Abusamra, Ph.D.
- Phone Number: 00201005084303
- Email: amirabousamra69@gmail.com
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Principal Investigator:
- Ahmed Elmasry, Ph.D.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
We will enroll all patients who meet the inclusion criteria and signed a written informed consent form.
Description
Inclusion Criteria:
- Patients with KC.
Exclusion Criteria:
- Patients who cannot give an informed consent.
- Patients who cannot provide needed samples for any reason
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
measuring the serum concentrations of free T4 (fT4) and thyroid-stimulating hormone (TSH)
Time Frame: We will recruit patients who meet the inclusion criteria during the study period of 3 months (June- August 2018). We will take only one blood sample from each patient recruited after the recrutiement and during this period
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The endocrinologic examination will include measuring the serum concentrations of free T4 (fT4) and thyroid-stimulating hormone (TSH) using an immunoassay method (ADVIA Centaur; Bayer Diagnostics, Germany).
The normal reference ranges for TSH and fT4 were determined to be 0.35 to 4.5 mIU/ L and 0.7 to 1.65 ng/dL, respectively.
Clinical cases with fT4 serum concentrations beyond these reference ranges will be defined as TGD.
All examinations will be handled anonymously.
|
We will recruit patients who meet the inclusion criteria during the study period of 3 months (June- August 2018). We will take only one blood sample from each patient recruited after the recrutiement and during this period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2018
Primary Completion (Anticipated)
August 30, 2018
Study Completion (Anticipated)
September 15, 2018
Study Registration Dates
First Submitted
August 15, 2018
First Submitted That Met QC Criteria
August 16, 2018
First Posted (Actual)
August 20, 2018
Study Record Updates
Last Update Posted (Actual)
August 20, 2018
Last Update Submitted That Met QC Criteria
August 16, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5621
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Keratoconus
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-
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