Incidence of Macular Edema in a Uveitis Population

Active, not recruiting

• Conditions: Macular Edema; Non-infectious Uveitis
• Interventions: Drug: Local and systemical treatment

• Registration Number: NCT06686641
• Lead Sponsor: Aalborg University Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-01
• Status Verified: 2024-10
• Primary Completion: 2024-10-31
• Study First Submitted: 2024-11-12
• Study First Submitted QC: 2024-11-12
• Last Update Submitted: 2024-11-12
• Study First Posted: 2024-11-13
• Last Update Posted: 2024-11-13
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1550

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-infectious uveitis patients treated at a hospitals in the North Denmark Region	Local and systemical treatment	-

Primary Outcome Measures

Name	Time	Method
Incidence of Macular Edema in patients with Uveitis	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.

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, Nordjylland, Denmark