NCT06579885

Ocular Complications of Mpox in the Democratic Republic Congo

Mapping the Burden of Ocular Complications of Mpox in the Democratic Republic Congo (DRC)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 320 (actual)
• Sponsor: Institute of Tropical Medicine, Belgium · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Monkeypox
• Mpox (Monkeypox)

Timeline

• Start date: 2024-10-28
• Primary completion: 2025-08-29
• Completion: 2025-08-29
• First posted: 2024-08-30
• Last updated: 2026-03-12

Locations

1 site across 1 country: Democratic Republic of the Congo