Keratoconus in Thyroid Gland DysfunctionNCT04346992
Prevalence Of Keratoconus Among Patients With Thyroid Gland Dysfunction
An observational study of Keratoconus in Thyroid Gland Dysfunction, run by Fayoum University at 1 site in Egypt.
Trial summary
Hormonal imbalances are likely to affect the corneal metabolism and may be also associated with Keratoconus. Among the various endocrinologic dysfunctions assumed so far, thyroid gland dysfunction (TGD) (hypo- or hyperthyroidism; comprised as TGD) is frequently associated with eye diseases such as Graves disease Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Keratoconus in Thyroid Gland Dysfunction
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Apr 2020to 15 Mar 2022
- 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 70 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
- All patients diagnosed as thyroid gland dysfunction
Who cannot join
- Uncooperative patients
Trial locations and contacts
1 site in 1 country.
About this study
Hormonal imbalances are likely to affect the corneal metabolism and may be also associated with Keratoconus. Among the various endocrinologic dysfunctions assumed so far, thyroid gland dysfunction (TGD) (hypo- or hyperthyroidism; comprised as TGD) is frequently associated with eye diseases such as Graves disease
Read the detailed description
Aim of the work
We aim to examine the prevalence of KC among patients already diagnosed by endocrinologist with TGD.
Materials and methods
Our Screening for KC will include evaluation of the demographic data and complete ophthalmological examination of the patients using:
VA Refraction K reading Slit lamp examination Pentacam Study design Epidemiological study
Inclusion citeria All patients diagnosed as thyroid gland dysfunction Control group
Exclusion criteria Uncooperative patients
- Conditions
- Keratoconus in Thyroid Gland Dysfunction
- Being tested
- no intervention
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.
prevalence of keratoconus in thyroid gland dysfunction
Our Screening for KC will include evaluation of the demographic data and complete ophthalmological examination of the patients using:
VA Refraction K reading Slit lamp examination Pentacam
Measured: we will recruit patients who meer the inclusion criteria during the study period April-August 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start12 Apr 2020
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratoconus in Thyroid Gland DysfunctionStudies of the same condition, open and under way.
- More trials run by Fayoum 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Said, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346992
- Sponsor's protocol ID
- R109
- Status last verified
- Sep 2022
- First submitted
- 12 Apr 2020
- Last updated
- 8 Sep 2022
- 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 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence Of Keratoconus Among Patients With Thyroid Gland Dysfunction
- ClinicalTrials.gov ID
- NCT04346992
- Acronym / sponsor ID
- R109
- Conditions
- Keratoconus in Thyroid Gland Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 12 Apr 2020 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 15 Apr 2020 (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.
Hormonal imbalances are likely to affect the corneal metabolism and may be also associated with Keratoconus. Among the various endocrinologic dysfunctions assumed so far, thyroid gland dysfunction (TGD) (hypo- or hyperthyroidism; comprised as TGD) is frequently associated with eye diseases such as Graves disease
Detailed description
Aim of the work
We aim to examine the prevalence of KC among patients already diagnosed by endocrinologist with TGD.
Materials and methods
Our Screening for KC will include evaluation of the demographic data and complete ophthalmological examination of the patients using:
VA Refraction K reading Slit lamp examination Pentacam Study design Epidemiological study
Inclusion citeria All patients diagnosed as thyroid gland dysfunction Control group
Exclusion criteria Uncooperative patients
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 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)
- All patients diagnosed as thyroid gland dysfunction
Key exclusion criteria (1 listed)
- Uncooperative patients
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
prevalence of keratoconus in thyroid gland dysfunction
Time frame: we will recruit patients who meer the inclusion criteria during the study period April-August 2020
Our Screening for KC will include evaluation of the demographic data and complete ophthalmological examination of the patients using: VA Refraction K reading Slit lamp examination Pentacam
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 in Thyroid Gland Dysfunction, run by Fayoum 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 1 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: finished, as of the sponsor's last update on 8 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of keratoconus in thyroid gland dysfunction (time frame: we will recruit patients who meer the inclusion criteria during the study period April-August 2020). 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 8 Sep 2022.