NCT03637673

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2018

Completed
Last Updated

August 20, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

August 15, 2018

Last Update Submit

August 16, 2018

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

Interventions

No interventionOTHER

No intervention

Eligibility Criteria

Age18 Years - 100 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:

  • Patients with KC.

You may not qualify if:

  • Patients who cannot give an informed consent.
  • Patients who cannot provide needed samples for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria Faculty of Medicine

Alexandria, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples to measure T3,T4, TSH level

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Central Study Contacts

Amir Abousamra, Ph.D.

CONTACT

00201005084303amirabousamra69@gmail.com

Mohamed Fahmy Doheim

CONTACT

001221081590fahmydehim21@gmail.com

Study Design

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

Study Record Dates

First Submitted

August 15, 2018

First Posted

August 20, 2018

Study Start

June 1, 2018

Primary Completion

August 30, 2018

Study Completion

September 15, 2018

Last Updated

August 20, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)