NCT04346992

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 12, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

September 8, 2022

Status Verified

September 1, 2022

Enrollment Period

1.9 years

First QC Date

April 12, 2020

Last Update Submit

September 2, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    we will recruit patients who meer the inclusion criteria during the study period April-August 2020

Interventions

no intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

we will enroll all patients who meet the inclusion criteria and signed a written informed consent form

You may qualify if:

  • All patients diagnosed as thyroid gland dysfunction

You may not qualify if:

  • Uncooperative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum University

Al Fayyum, 63514, Egypt

Location

Biospecimen

blood sample to measure thyroid profile

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 12, 2020

First Posted

April 15, 2020

Study Start

April 12, 2020

Primary Completion

March 15, 2022

Study Completion

March 15, 2022

Last Updated

September 8, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations