MonkeypoxMPOX-EYENCT06579885
Ocular Complications of Mpox in the Democratic Republic Congo
An observational study of Monkeypox and Mpox (Monkeypox), run by Institute of Tropical Medicine, Belgium at 1 site in Democratic Republic of the Congo.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Monkeypox, Mpox (Monkeypox)
- How many people
- 320 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 28 Oct 2024to 29 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients for whom, in the judgment of the recruiting physician, participation in the study would interfere with routine optimal clinical care.
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Kamituga General Hospital
Kamituga, South Kivu
About this study
Official title: 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.
Read the 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)
- Keywords
- ophthalmology, complications
- Medical subject headings
- Mpox, Monkeypox
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At enrollment
Secondary outcomes (3)
Ocular signs & symptoms at presentation and during follow-up
Presence or absence of individual symptoms and signs over time
Measured: 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
Measured: 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
Measured: From enrollment until last follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start28 Oct 2024
- Primary completion29 Aug 2025
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MonkeypoxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Institut National de Recherche Biomedicale (INRB)
- Responsible party
- Sponsor
- Investigators
- Laurens Liesenborghs, Professor, Study director, Institute of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579885
- Sponsor's protocol ID
- MPOX-EYE
- Acronym
- MPOX-EYE
- Status last verified
- Mar 2026
- First submitted
- 29 Aug 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping the Burden of Ocular Complications of Mpox in the Democratic Republic Congo (DRC)
- ClinicalTrials.gov ID
- NCT06579885
- Acronym / sponsor ID
- MPOX-EYE / MPOX-EYE
- Conditions
- Monkeypox, Mpox (Monkeypox)
- Keywords
- ophthalmology, complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Institut National de Recherche Biomedicale (INRB)
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients for whom, in the judgment of the recruiting physician, participation in the study would interfere with routine optimal clinical care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite presence or absence of eye disease and visual deficiencies at presentation
Time frame: 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
3 secondary outcomes
Ocular signs & symptoms at presentation and during follow-up
Time frame: From enrollment until last follow-up
Visual acuity at presentation and during follow-up
Time frame: From enrollment until last follow-up
presence of MPXV in tear fluid at presentation and during follow-up
Time frame: From enrollment until last follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurens Liesenborghs, Professor study director
Institute of Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monkeypox and Mpox (Monkeypox), run by Institute of Tropical Medicine, Belgium at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite presence or absence of eye disease and visual deficiencies at presentation (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.