Ocular Complications of Mpox in the Democratic Republic Congo (MPOX-EYE)

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

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.

Study Overview

• Status: Completed
• Conditions: Monkeypox; Mpox (Monkeypox)

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.

• Study Type: Observational
• Enrollment (Actual): 320

Contacts and Locations

Study Locations

• Democratic Republic of the Congo
  • South Kivu
    • Kamituga, South Kivu, Democratic Republic of the Congo
      • Kamituga General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular signs & symptoms at presentation and during follow-up	Presence or absence of individual symptoms and signs over time	From enrollment until last follow-up
Visual acuity at presentation and during follow-up	Result of Optotype letters/numbers and/or E test over time	From enrollment until last follow-up
presence of MPXV in tear fluid at presentation and during follow-up	Result of MPXV-Polymerase Chain Reaction (PCR) on conjunctival swabs over time	From enrollment until last follow-up

Collaborators and Investigators

• Sponsor: Institute of Tropical Medicine, Belgium
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
• Investigators: Study Director: Laurens Liesenborghs, Professor, Institute of Tropical Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2024
• Primary Completion (Actual): August 29, 2025
• Study Completion (Actual): August 29, 2025

Study Registration Dates

• First Submitted: August 29, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: complications; ophthalmology
• Additional Relevant MeSH Terms: Infections; Virus Diseases; Poxviridae Infections; DNA Virus Infections; Animal Diseases; Primate Diseases; Rodent Diseases; Mpox, Monkeypox
• Other Study ID Numbers: MPOX-EYE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No