Skip to main content
Clinical Trials/NCT06686641
NCT06686641Active, not recruitingNot Applicable

Incidence of Macular Edema in a Uveitis Population of 1500 Patients

Aalborg University Hospital1 site in 1 country1,550 target enrollmentStarted: May 1, 2024Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
1,550
Locations
1
Primary Endpoint
Incidence of Macular Edema in patients with Uveitis

Study Overview

Brief Summary

Macular edema from uveitis is a serious condition that can lead to vision loss. Uveitis is an inflammation inside the eye, and macular edema is when fluid builds up in the central part of the retina, called the macula, which is crucial for clear vision. This fluid buildup can blur vision, sometimes severely. Managing this condition can be challenging and may require several treatments to reduce the fluid and protect sight. While we know macular edema is a common cause of vision loss in uveitis, there's limited data on how often it affects people in Europe

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Hospital-admitted patients in the North Denmark Region with non-infectious uveitis.
  • Both juvenile and adult patients.
  • Diagnosed with non-infectious uveitis by a medical doctor.
  • Patients presenting with unspecific macular edema may be included if medical records indicate uveitis as the cause of the edema.

Exclusion Criteria

  • Patients incorrectly classified as having uveitis based on their medical records (no confirmed diagnosis of uveitis).
  • Patients with infectious uveitis.
  • Macular edema due to other cause than uveitis will not count as uveitis associated edema

Arms & Interventions

Non-infectious uveitis patients treated at a hospitals in the North Denmark Region

Intervention: Local and systemical treatment (Drug)

Outcomes

Primary Outcomes

Incidence of Macular Edema in patients with Uveitis

Time Frame: 10 years

The outcome of interest is macular edema in non-infectious uveitis. We will estimate the incidence rate and cumulative incidence of macular edema in patients with uveitis. In addition, the population will be stratified according to sex, age, non-infectious uveitis subtype, HLA- subtype, and ethnicity (if available), and the rate and risk of macular edema will be assessed for each strata. The incidence rate for macular edema will be calculated for a 1-10 years follow-up periods. Furthermore, the cumulative incidence will be assessed using the Aalen Johansen estimator. The stratified groups will be compared using a cox proportional hazard model to quantify the differences between the respective groups. Patients will be excluded if essential information is missing in their medical journal. Follow-up will terminate in case the patient moves to an address outside the North Denmark Region.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lasse Jørgensen Cehofski

Dr. Lasse J. Cehofski

Aalborg University Hospital

Study Sites (1)

Loading locations...

Similar Trials

Incidence of Macular Edema in a Uveitis... | Clinical Trial