NCT06235372

Brief Summary

To investigate corneal endothelial cell layer damage by specular microscopy in patients with thyroid eye disease

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2024

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

First Submitted

Initial submission to the registry

December 22, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 21, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2025

Completed
Last Updated

March 20, 2024

Status Verified

January 1, 2024

Enrollment Period

1.6 years

First QC Date

December 22, 2023

Last Update Submit

March 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Damage of the corneal endothelial cells in patients with thyroid eye disease by specular microscopy

    To detect if there is any change in corneal endothelial cell layer in patients with thyroid eye disease

    Baseline

Interventions

Specular microscopy is a noninvasive photographic technique that analyze the corneal endothelium. Using computer-assisted morphometry, modern specular microscopes analyze the size, shape and population of the endothelial cells. The instrument projects light onto the cornea and captures the image that is reflected from the optical interface between the corneal endothelium and the aqueous humor. The reflected image is analyzed by the instrument and displayed as a specular photomicrograph .

Eligibility Criteria

Age12 Years - 80 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with thyroid eye disease whom diagnosis was established based on bartley diagnostic criteria .

You may qualify if:

  • Patients with thyroid eye disease whom diagnosis was established based on bartley diagnostic criteria .

You may not qualify if:

  • participates with systemic diseases other than HT such as
  • diabetes mellitus
  • previous ocular surgery or laser therapy.
  • history of corneal disease.
  • history of trauma.
  • history of glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesGraves DiseaseExophthalmosOrbital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Study Officials

  • Dalia Mohammed, Professor

    Academic organizations

    STUDY DIRECTOR
  • Khaled Abdelazim, Assistant professor

    Academic organizations

    STUDY DIRECTOR
  • Ahmed Abdelnasser, Lecturer

    Academic organizations

    STUDY DIRECTOR

Central Study Contacts

Mayar Ashraf, Resident

CONTACT

Study Design

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

Study Record Dates

First Submitted

December 22, 2023

First Posted

January 31, 2024

Study Start

March 21, 2024

Primary Completion

October 22, 2025

Study Completion

December 22, 2025

Last Updated

March 20, 2024

Record last verified: 2024-01