Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579885
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Ocular Complications of Mpox in the Democratic Republic Congo
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Mapping the Burden of Ocular Complications of Mpox in the Democratic Republic Congo DRC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MPOX-EYE
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None