PREVAIL VII: Persistence of Ebola Virus in Aqueous Humor and Outcomes of Cataract Surgery in Survivors of Ebola Virus Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2021
• Main ID: NCT03309020
• Date of registration: 12/10/2017
• Prospective Registration: No
• Primary sponsor: National Eye Institute (NEI)
• Public title: PREVAIL VII: Persistence of Ebola Virus in Aqueous Humor and Outcomes of Cataract Surgery in Survivors of Ebola Virus Disease
• Scientific title: PREVAIL VII: Persistence of Ebola Virus in Aqueous Humor and Outcomes of Cataract Surgery in Survivors of Ebola Virus Disease
• Date of first enrolment: September 21, 2017
• Target sample size: 37
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03309020
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Liberia

Contacts

• Name: Teresa M Magone de Quadros Costa, M.D.
• Affiliation: National Eye Institute (NEI)

Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

To be eligible, the following inclusion criteria must be met, where applicable.

1. Participant must be 14 years of age or older.

2. 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.

3. 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.).

4. Participant must have visually significant cataract(s) consistent with level of visual
deficit.

5. 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.

6. 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.

1. 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.

2. Active uveitis at time of surgery or within the past three months, if documented.

3. 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.

4. 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.



Age minimum: 14 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cataract

Intervention(s)

Procedure: Cataract surgery

Primary Outcome(s)

Compare the amount of intraocular inflammation [Time Frame: One year]

Determine the proportion of EVD survivors with evidence of persistence of Ebola viral RNA in ocular tissue [Time Frame: One year]

Secondary Outcome(s)

Assess postoperative structural changes after intraocular surgery in EVD survivors. [Time Frame: 1 year]

Assess the effect of age and gender on Ebola virus persistence and cataract outcomes in EVD survivors [Time Frame: 1 year]

Assess visual outcomes of cataract surgery in EVD survivors [Time Frame: 1 year]

Secondary ID(s)

17-EI-N167

999917167

Source(s) of Monetary Support

Please refer to primary and secondary sponsors