An observational study in Monkeypox and Mpox (Monkeypox), sponsored by Institute of Tropical Medicine, Belgium. Completed at 1 site in Democratic Republic of the Congo. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Institute of Tropical Medicine, Belgium · Observational
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.
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.
72 studies on the registry are indexed under Mpox, Monkeypox; 30 are open to participants now.
This study's enrollment of 320 is above the median of 224 across 34 observational studies indexed under Mpox, Monkeypox.
Browse Mpox, Monkeypox studies →Institute of Tropical Medicine, Belgium is the lead sponsor of 104 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study will take place in parallel to:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Time frame: At enrollment
Ocular signs & symptoms at presentation and during follow-up
Presence or absence of individual symptoms and signs over time
Time frame: 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
Time frame: 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
Time frame: From enrollment until last follow-up
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Oct 2024 to primary completion in Aug 2025, 10 months.
Of 23 observational studies under Mpox, Monkeypox, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Institute of Tropical Medicine, Belgium →