Mapping the Burden of Ocular Complications of Mpox in the Democratic Republic Congo (DRC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Composite presence or absence of eye disease and visual deficiencies at presentation
研究概览
简要总结
This is an observational study in which patients diagnosed with mpox will be enrolled, will undergo standard ophthalmological examinations of their eyes to see if there are any complications of mpox. The study will primarily assess the presence of ophthalmological signs and symptoms at enrollment.
详细描述
This is an observational study in which patients diagnosed with mpox will be enrolled in two clinics in remote settings in the DR Congo (Tunda and Kole general hospital) where mpox outbreaks are ongoing. After providing informed consent, participants will undergo standard ophthalmological examinations of their eyes to see if there are any complications of mpox. This includes history taking, clinical examination, technical examinations such as a dilated fundoscopic exam, a fluorescein test and a Schirmer test, and a conjunctival swab for tear collection for monkeypox virus (MPXV) detection. Pictures of the anterior and posterior segment will also be taken to aid later verification and interpretation of the study findings. If they are hospitalised for mpox (for clinical reasons or as part of their participation in another ongoing clinical trial at the study sites), they will be followed up for 14 days and examined during an unscheduled visit in the case of new or worsening severe issues. Otherwise, patients are followed up at day 14 (for those hospitalised), day 28 and day 59. Study participants will receive the same supportive eye care as non-study participants. Study participants will be compensated for their time lost and for transportation to the clinic.
The study will primarily assess the presence of ophthalmological signs and symptoms at enrollment, but also aims to describe the complications of mpox that may arise after that point in time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient of any age or gender with laboratory-confirmed infection with MPXV
- •Laboratory confirmation of MPXV infection less than 48 hours before inclusion
- •Patient or culturally acceptable representative is willing and able to give informed consent or assent for participation in the study
排除标准
- •Patients for whom, in the judgment of the recruiting physician, participation in the study would interfere with routine optimal clinical care.
结局指标
主要结局
Composite presence or absence of eye disease and visual deficiencies at presentation
时间窗: At enrollment
Composite presence of * orbital lesions (exophthalmos, enophthalmos, oculomotor paralysis...) * affection of the adnexa * affection of the anterior segment * affection of the posterior segment * affection of the optic nerve
次要结局
- Ocular signs & symptoms at presentation and during follow-up(From enrollment until last follow-up)
- Visual acuity at presentation and during follow-up(From enrollment until last follow-up)
- presence of MPXV in tear fluid at presentation and during follow-up(From enrollment until last follow-up)