KeratoconusNCT03637673
The Possible Role of Thyroxine in Keratoconus Development
An observational study of Keratoconus, run by Alexandria University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Keratoconus
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2018to 15 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will enroll all patients who meet the inclusion criteria and signed a written informed consent form.
Who may be able to join
- Patients with KC.
Who cannot join
- Patients who cannot give an informed consent.
- Patients who cannot provide needed samples for any reason
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria Faculty of Medicine
Alexandria
Amir Abusamra, Ph.D., 00201005084303, amirabousamra69@gmail.com
Ahmed Elmasry, Ph.D.
About this study
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.
Read the 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.
- Conditions
- Keratoconus
- Being tested
- No intervention
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring the serum concentrations of free T4 (fT4) and thyroid-stimulating hormone (TSH)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start1 Jun 2018
- Primary completion30 Aug 2018 (estimated)
- Study completion15 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir abou Samra, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637673
- Sponsor's protocol ID
- 5621
- Status last verified
- Aug 2018
- First submitted
- 15 Aug 2018
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Possible Role of Thyroxine in Keratoconus Development
- ClinicalTrials.gov ID
- NCT03637673
- Acronym / sponsor ID
- 5621
- Conditions
- Keratoconus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Aug 2018 (estimated)
- Study completion
- 15 Sep 2018 (estimated)
- First posted
- 20 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will enroll all patients who meet the inclusion criteria and signed a written informed consent form.
Key inclusion criteria (1 listed)
- Patients with KC.
Key exclusion criteria (2 listed)
- Patients who cannot give an informed consent.
- Patients who cannot provide needed samples for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amir Abousamra, Ph.D. (00201005084303, amirabousamra69@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018; AzTrials last refreshed its copy on 2 Nov 2026.