Ocular Complications of Mpox in the Democratic Republic Congo

NCT06579885 | Completed

• 1 other identifier: MPOX-EYE
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Monkeypox; Mpox (Monkeypox)

Keywords

ophthalmology; complications

Outcome Measures

Primary Outcomes (1)

• Composite presence or absence of eye disease and visual deficiencies at presentation

  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

  At enrollment

Secondary Outcomes (3)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will take place in parallel to: * the PALM007 clinical trial (NCT05559099), which evaluates the efficacy of tecovirimat for the treatment of mpox in two sites in the Democratic Republic of the Congo: Tunda General Hospital, Maniema Province and Kole General Hospital, Sankuru Province. * The MBOTE study, which evaluates the clinical signs and symptoms in people with mpox at Kamituga General Hospital, South Kivu Province. Depending on the mpox epidemiological context other sites can be included at a later timepoint. The study may be continued after cessation of the PALM007 trial. Participants will be recruited among PCR-confirmed mpox cases, including but not limited to patients enrolled in the PALM 007 trial and MBOTE study. The study may be continued after cessation of the PALM007 trial and MBOTE study.

You may qualify if:

• Patient of any age or gender with laboratory-confirmed infection with MPXV
• Patient or culturally acceptable representative is willing and able to give informed consent or assent for participation in the study

You may not qualify if:

• Patients for whom, in the judgment of the recruiting physician, participation in the study would interfere with routine optimal clinical care.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo: collaborator
• Institute of Tropical Medicine, Belgium: lead

Study Sites (1)

Kamituga General Hospital

Kamituga, South Kivu, Democratic Republic of the Congo

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tear fluid samples

MeSH Terms

Conditions

Mpox, Monkeypox

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Study Officials

• Laurens Liesenborghs, Professor

  Institute of Tropical Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: August 30, 2024
• Study Start: October 28, 2024
• Primary Completion: August 29, 2025
• Study Completion: August 29, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

DE (1)