Prevalence Of Keratoconus Among Patients With Thyroid Gla... | NCT04346992

Studies
Prevalence Of Keratoconus Among Patients With Thyroid Gland Dysfunction

NCT04346992

Sponsor

Fayoum University

Status

Completed

Last Update Posted

Sep 8, 2022Actual

Enrollment

400Actual

Phase

Not provided

Conditions

Keratoconus in Thyroid Gland Dysfunction

Interventions

no intervention

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2020Actual

Primary Completion Date

Mar 15, 2022Actual

Completion Date

Mar 15, 2022Actual

First Submitted Date

Apr 12, 2020

First Submission Date that Met QC Criteria

Apr 12, 2020

First Posted Date

Apr 15, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2022

Last Update Posted Date

Sep 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Not provided

Description

Enrollment

400Actual

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients diagnosed as thyroid gland dysfunction

Exclusion Criteria:

Uncooperative patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fayoum University		Al Fayyum		63514	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided