NCT06759207

Brief Summary

Corneal transparency is a result of its unique ultrastructure with collagen fibrils regularity, integrity of connective tissue, and balanced keratocyte components. Corneal densitometry is known to be altered in cases corneal haze or scar, but recently it is assumed to be altered earlies in presence of a systemic inflammatory disease, even before clinical manifestations take place. The aim of this study is to assess changes in corneal topography and corneal densitometry in RA patients with clinically clear corneas and to compare these results with those of healthy control subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

January 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

December 28, 2024

Last Update Submit

April 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Corneal topographic changes and densitometry in patients with rheumatoid arthritis

    one year

Study Arms (1)

Rheumatoid arthritis patients

Pentacam

Eligibility Criteria

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

All patients have RA presented for ophthalmic clinic during the period of the study

You may qualify if:

  • Patients diagnosed with rheumatoid arthritis

You may not qualify if:

  • corneal opacity; severe dry eye; glaucoma; any inflammatory ocular disorder or infection including blepharitis, conjunctivitis, meibomitis and dacryocystitis; central or peripheral thinning evident in slit-lamp examination; history of ocular surgery, trauma, or contact lens use; and patients using any topical medication other than artificial tears will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Amr Mounir

Sohag, Egypt

Location

Elshimaa A.Mateen

Sohag, Egypt

Location

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Elshimaa A.Mateen, Doctor

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 28, 2024

First Posted

January 6, 2025

Study Start

January 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2025

Last Updated

May 1, 2025

Record last verified: 2025-04

Locations