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Clinical Trials/NCT06686641
NCT06686641
Active, not recruiting
Not Applicable

Incidence of Macular Edema in a Uveitis Population of 1500 Patients

Aalborg University Hospital1 site in 1 country1,550 target enrollmentMay 1, 2024

Overview

Phase
Not Applicable
Intervention
Local and systemical treatment
Conditions
Macular Edema
Sponsor
Aalborg University Hospital
Enrollment
1550
Locations
1
Primary Endpoint
Incidence of Macular Edema in patients with Uveitis
Status
Active, not recruiting
Last Updated
last year

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

Registry
clinicaltrials.gov
Start Date
May 1, 2024
End Date
February 1, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lasse Jørgensen Cehofski

Dr. Lasse J. Cehofski

Aalborg University Hospital

Eligibility Criteria

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

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.

Study Sites (1)

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