Clinical trial NCT06686641: Incidence of Macular Edema in a Uveitis Population
Official title: Incidence of Macular Edema in a Uveitis Population of 1500 Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Macular Edema
Non-infectious Uveitis
Keywords: Epidemiology of uveitis
Incidence of macular edema in a uveitis population
Management of macular edema secondary to uveitis
Uveitis
Macular Edema
Non infectious uveitis
Non-infectious uveitis
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 1550
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of all uveitis patients treated at hospitals in the North Denmark Region.The included study population consists of all patients with a primary or secondary first-time discharge diagnosis of uveitis from the ophthalmologic department at Aalborg University Hospital in the North Denmark Region. Both inpatient and outpatient diagnoses are included. The following ICD-10 codes for uveitis will be included: DH200 acute and subacute anterior uveitis, DH201 Chronic anterior uveitis, DH209 anterior uveitis unspecified, DH208 other anterior uveitis, DH300 focal posterior uveitis, DH309 posterior uveitis unspecified, DH308 other posterior uveitis, DH301 disseminated posterior uveitis, DH302 intermediate uveitis, and DH441E panuveitis

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


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

Primary outcomes:
measure: Incidence of Macular Edema in patients with Uveitis
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: Nordjylland
Study officials:
affiliation: Aalborg University Hospital
name: Lasse J Cehofski, MD, P.h.d
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ørskov et al. J Pers Med. 2023 8;13(6):970
citation: Xue YQ, Xiao JA, Chen Y. Frequency and Treatment Regimens of Macular Edema in 1946 Consecutive Patients with Noninfectious Uveitis at a Tertiary Ophthalmic Center in Shaanxi, China. Ophthalmol Ther. 2023 Oct;12(5):2609-2619. doi: 10.1007/s40123-023-00763-4. Epub 2023 Jul 13.
citation: Koronis S, Stavrakas P, Balidis M, Kozeis N, Tranos PG. Update in treatment of uveitic macular edema. Drug Des Devel Ther. 2019 Feb 19;13:667-680. doi: 10.2147/DDDT.S166092. eCollection 2019.
citation: Massa H, Pipis SY, Adewoyin T, Vergados A, Patra S, Panos GD. Macular edema associated with non-infectious uveitis: pathophysiology, etiology, prevalence, impact and management challenges. Clin Ophthalmol. 2019 Sep 10;13:1761-1777. doi: 10.2147/OPTH.S180580. eCollection 2019.