Status:
COMPLETED
PREVAIL VII: Cataract Surgery in Ebola Survivors
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Cataract
Eligibility:
All Genders
14+ years
Phase:
NA
Brief Summary
Objective: Zaire ebolavirus is a single-stranded RNA virus associated with high morbidity and mortality. The most recent epidemic of Ebola virus disease (EVD) in West Africa resulted in over 11,000 de...
Detailed Description
Objective: Zaire ebolavirus is a single-stranded RNA virus associated with high morbidity and mortality. The most recent epidemic of Ebola virus disease (EVD) in West Africa resulted in over 11,000 de...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- To be eligible, the following inclusion criteria must be met, where applicable.
- Participant must be 14 years of age or older.
- Participant must be able to understand and sign an informed consent or have a parent/legal guardian do so if they are minor children or a legally authorized representative to provide consent for adults without consent capacity.
- Participant must be either:
- an Ebola virus disease (EVD) seropositive survivor or seropositive control OR
- an EVD seronegative survivor or seronegative control (Serology confirmation is available for PREVAIL participants and will be conducted for non-PREVAIL participants.).
- Participant must have visually significant cataract(s) consistent with level of visual deficit.
- Participant must have corrected visual acuity worse than 20/40 in affected eye and vision loss believed to be primarily the result of the cataract.
- Any woman and persons of childbearing potential age have a negative pregnancy test at screening and must be willing to undergo pregnancy testing prior to the cataract surgery.
- EXCLUSION CRITERIA:
- A participant is not eligible if any of the following exclusion criteria are present.
- Concurrent life-threatening illness or other condition that compromises a participant's ability to safely undergo surgery, as determined by the surgical and medical team, including any condition that prevents the participant from lying down supine or remaining still, such as severe lung disease, or a known life-threatening, untreated or unstable cardiac or pulmonary condition.
- Active uveitis at time of surgery or within the past three months, if documented.
- Participant is pregnant, as surgery is elective and no adequate data regarding the use of postoperative topical antibiotic-steroid combination drops exists in pregnant women.
- Any condition that poses a risk to the participant having a safe surgical or post-operative experience, including known inability or unwillingness to follow up for the full duration of the protocol.
Exclusion
Key Trial Info
Start Date :
September 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03309020
Start Date
September 21 2017
End Date
August 1 2019
Last Update
June 29 2021
Active Locations (1)
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1
PREVAIL JFK Hospital
Monrovia, Liberia