Incidence of Macular Edema in a Uveitis Population

N/AActive Not RecruitingNCT06686641

Aalborg University Hospital1,550 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,550

Conditions

Macular Edema Non-infectious Uveitis

Interventions

Local and systemical treatmentDRUG

Evaluating the management of the edema including topical/local treatment (dexamethasone and NSAID, periocular injections, and dexamethasone intravitreal implant) and systemic treatment (prednisolone, DMARD, and biological agents, for example TNF-alpha inhibitors and interleukin-6 inhibitors). Moreover, the duration of any treatment as well as numbers of injections or implants.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Aalborg University Hospital

Aalborg, North Denmark, Denmark

Outcomes

Primary Outcomes

Incidence of Macular Edema in patients with Uveitis

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.

Time frame: 10 years

Data from ClinicalTrials.gov

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