Trial Outcomes & Findings for PREVAIL VII: Cataract Surgery in Ebola Survivors (NCT NCT03309020)
NCT ID: NCT03309020
Last Updated: 2021-06-29
Results Overview
Participants undergo aqueous fluid (aqueous humor) sampling to assess for the presence of Ebola virus RNA via RT-PCR using the GeneXpert assay. The study was intended to include analysis of lens tissue to explore detection of the presence of virus in lens tissue in EVD survivors; however, the collected lens tissue samples were damaged during storage and transport. Therefore, the lens samples were unable to yield any reportable data.
COMPLETED
NA
37 participants
One week prior to cataract surgery
2021-06-29
Participant Flow
Participant milestones
| Measure |
Control
Control with clinical need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
EVD Survivors
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
25
|
|
Overall Study
Underwent Cataract Surgery
|
10
|
24
|
|
Overall Study
COMPLETED
|
9
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Control
Control with clinical need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
EVD Survivors
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Did not undergo surgery
|
2
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control
n=12 Participants
Control with clinical need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
EVD Survivors
n=25 Participants
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
n=12 Participants
|
62 years
n=25 Participants
|
59 years
n=37 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=12 Participants
|
14 Participants
n=25 Participants
|
20 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=12 Participants
|
11 Participants
n=25 Participants
|
17 Participants
n=37 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Liberia
|
12 participants
n=12 Participants
|
25 participants
n=25 Participants
|
37 participants
n=37 Participants
|
PRIMARY outcome
Timeframe: One week prior to cataract surgeryPopulation: Ebola survivors in the analytic population (seropositive EVD survivors who underwent cataract surgery)
Participants undergo aqueous fluid (aqueous humor) sampling to assess for the presence of Ebola virus RNA via RT-PCR using the GeneXpert assay. The study was intended to include analysis of lens tissue to explore detection of the presence of virus in lens tissue in EVD survivors; however, the collected lens tissue samples were damaged during storage and transport. Therefore, the lens samples were unable to yield any reportable data.
Outcome measures
| Measure |
EVD Survivors
n=22 Participants
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
EVD Survivors
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
|---|---|---|
|
Proportion of EVD Survivors With Evidence of Persistence of Ebola Viral RNA in Ocular Tissue
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: 1 month after cataract surgeryPopulation: Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
The amount of intraocular inflammation is measured by the average grade of anterior chamber (AC) cell per Standardization of Uveitis Nomenclature (SUN) criteria. AC cell grading, with higher grades indicating a worse outcome: Grade 0 -- 0-5 cells per 1 mm x 1 mm high-powered field; Grade 1 -- 6-15 cells per 1 mm x 1 mm high-powered field; Grade 2 -- 16-25 cells per 1 mm x 1 mm high-powered field; Grade 3 -- 26-50 cells per 1 mm x 1 mm high-powered field; Grade 4 -- \> 50 cells per 1 mm x 1 mm high-powered field
Outcome measures
| Measure |
EVD Survivors
n=12 eyes
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
EVD Survivors
n=22 eyes
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
|---|---|---|
|
Comparison of the Amount of Intraocular Inflammation Between EVD Survivors and Controls at 1 Month Following Cataract Surgery
|
.67 AC cell grade
Standard Deviation .49
|
.64 AC cell grade
Standard Deviation .66
|
PRIMARY outcome
Timeframe: 3 months after cataract surgeryPopulation: Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
The amount of intraocular inflammation is measured by the average grade of anterior chamber cell per Standardization of Uveitis Nomenclature (SUN) criteria. AC cell grading, with higher grades indicating a worse outcome: Grade 0 -- 0-5 cells per 1 mm x 1 mm high-powered field; Grade 1 -- 6-15 cells per 1 mm x 1 mm high-powered field; Grade 2 -- 16-25 cells per 1 mm x 1 mm high-powered field; Grade 3 -- 26-50 cells per 1 mm x 1 mm high-powered field; Grade 4 -- \> 50 cells per 1 mm x 1 mm high-powered field
Outcome measures
| Measure |
EVD Survivors
n=8 Participants
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
EVD Survivors
n=22 Participants
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
|---|---|---|
|
Comparison of the Amount of Intraocular Inflammation Between EVD Survivors and Controls at 3 Months Following Cataract Surgery
|
.5 AC cell grade
Standard Deviation 1.17
|
.82 AC cell grade
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: 12 months (1 year) after cataract surgeryPopulation: Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Comparison of proportion with at least 20/40 best corrected visual acuity (BCVA) after cataract surgery 12 months in survivors vs controls. Best corrected visual acuity was measured using the Tumbling-E Early Treatment Diabetic Retinopathy Study (ETDRS) protocol vision chart. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
EVD Survivors
n=12 eyes
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
EVD Survivors
n=21 eyes
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
|---|---|---|
|
Comparison of Proportion of Eyes With at Least 20/40 Best Corrected Visual Acuity (BCVA) 12 Months After Cataract Surgery
|
5 eyes
|
18 eyes
|
SECONDARY outcome
Timeframe: Baseline to 12 months (1 year) after cataract surgeryPopulation: Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Optical coherence tomography (OCT) imaging of the retina and optic nerve was used to identify the presence of intraretinal fluid cysts in EVD survivors vs. controls from baseline to 12 months after surgery
Outcome measures
| Measure |
EVD Survivors
n=12 eyes
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
EVD Survivors
n=22 eyes
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
|---|---|---|
|
Comparison of Intraretinal Fluid Cysts Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery
Baseline
|
0 eyes
|
0 eyes
|
|
Comparison of Intraretinal Fluid Cysts Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery
Month 1
|
0 eyes
|
0 eyes
|
|
Comparison of Intraretinal Fluid Cysts Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery
Month 3
|
1 eyes
|
3 eyes
|
|
Comparison of Intraretinal Fluid Cysts Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery
Month 6
|
0 eyes
|
1 eyes
|
|
Comparison of Intraretinal Fluid Cysts Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery
Month 9
|
1 eyes
|
2 eyes
|
|
Comparison of Intraretinal Fluid Cysts Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery
Month 12
|
2 eyes
|
2 eyes
|
SECONDARY outcome
Timeframe: Baseline to 12 months (1 year) after cataract surgeryPopulation: Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Optical coherence tomography (OCT) imaging of the retina and optic nerve was used to measure macular central subfield thickness (CST) in µm in EVD survivors vs. controls from baseline to 12 months after cataract surgery
Outcome measures
| Measure |
EVD Survivors
n=12 eyes
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
EVD Survivors
n=22 eyes
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
|---|---|---|
|
Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery
Baseline
|
203 µm
Interval 182.0 to 204.0
|
209 µm
Interval 184.0 to 244.5
|
|
Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery
Month 1
|
222 µm
Interval 217.5 to 260.0
|
224 µm
Interval 211.0 to 269.5
|
|
Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery
Month 3
|
227 µm
Interval 196.8 to 260.2
|
216 µm
Interval 188.0 to 253.0
|
|
Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery
Month 6
|
226.5 µm
Interval 209.5 to 234.8
|
234 µm
Interval 203.0 to 258.0
|
|
Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery
Month 9
|
240 µm
Interval 227.8 to 258.2
|
238 µm
Interval 214.0 to 254.5
|
|
Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery
Month 12
|
244 µm
Interval 221.5 to 264.5
|
231 µm
Interval 212.5 to 245.5
|
SECONDARY outcome
Timeframe: Baseline to 12 months (1 year) after cataract surgeryPopulation: Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Optical coherence tomography (OCT) imaging of the retina and optic nerve was used to measure central subfield thickness (CST) in µm in EVD survivors vs. controls, excluding cases of intraretinal fluid cysts, from baseline to 12 months after cataract surgery
Outcome measures
| Measure |
EVD Survivors
n=12 eyes
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
EVD Survivors
n=22 eyes
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
|---|---|---|
|
Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls, Excluding Cases of Intraretinal Fluid Cysts, From Baseline to 12 Months After Cataract Surgery
Month 1
|
222 µm
Interval 217.5 to 260.0
|
224 µm
Interval 211.0 to 269.5
|
|
Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls, Excluding Cases of Intraretinal Fluid Cysts, From Baseline to 12 Months After Cataract Surgery
Month 3
|
223 µm
Interval 196.5 to 248.0
|
214 µm
Interval 183.5 to 224.0
|
|
Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls, Excluding Cases of Intraretinal Fluid Cysts, From Baseline to 12 Months After Cataract Surgery
Month 6
|
220 µm
Interval 207.0 to 234.0
|
229 µm
Interval 202.8 to 251.2
|
|
Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls, Excluding Cases of Intraretinal Fluid Cysts, From Baseline to 12 Months After Cataract Surgery
Baseline
|
203 µm
Interval 182.0 to 204.0
|
218 µm
Interval 190.2 to 244.0
|
|
Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls, Excluding Cases of Intraretinal Fluid Cysts, From Baseline to 12 Months After Cataract Surgery
Month 9
|
240 µm
Interval 225.5 to 253.0
|
238 µm
Interval 211.0 to 254.0
|
|
Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls, Excluding Cases of Intraretinal Fluid Cysts, From Baseline to 12 Months After Cataract Surgery
Month 12
|
242 µm
Interval 211.0 to 248.0
|
231 µm
Interval 216.0 to 244.0
|
SECONDARY outcome
Timeframe: Baseline to 12 months (1 year) after cataract surgeryPopulation: Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Visual acuity (20/x) was measured using the Tumbling-E Early Treatment Diabetic Retinopathy Study (ETDRS) protocol vision chart. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
EVD Survivors
n=34 eyes
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
EVD Survivors
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
|---|---|---|
|
Impact of Gender on Visual Acuity From Baseline to 12 Months After Surgery
Baseline
|
800 visual acuity (20/x)
Interval 100.0 to 4000.0
|
—
|
|
Impact of Gender on Visual Acuity From Baseline to 12 Months After Surgery
Month 1
|
40 visual acuity (20/x)
Interval 25.0 to 50.0
|
—
|
|
Impact of Gender on Visual Acuity From Baseline to 12 Months After Surgery
Month 12
|
32 visual acuity (20/x)
Interval 25.0 to 50.0
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 months (1 year) after cataract surgeryPopulation: Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Visual acuity was measured using the Tumbling-E Early Treatment Diabetic Retinopathy Study (ETDRS) protocol vision chart. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. Number of lines improvement equals the number of lines read at 12 months post cataract surgery minus the number of lines read at baseline
Outcome measures
| Measure |
EVD Survivors
n=34 eyes
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
EVD Survivors
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
|---|---|---|
|
Impact of Gender on Improvement in the Number of Lines Read on an ETDRS Eye Chart From Baseline to 12 Months After Surgery
|
8.06 lines of improvement
Interval 4.01 to 20.97
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 months (1 year) after cataract surgeryPopulation: Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Age was age at enrollment in years. Visual acuity (20/x) was measured using the Tumbling-E Early Treatment Diabetic Retinopathy Study (ETDRS) protocol vision chart. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
EVD Survivors
n=30 Participants
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
EVD Survivors
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
|---|---|---|
|
Impact of Age on Visual Acuity From Baseline to 12 Months After Surgery
Baseline
|
800 visual acuity (20/x)
Interval 100.0 to 4000.0
|
—
|
|
Impact of Age on Visual Acuity From Baseline to 12 Months After Surgery
Month 1
|
40 visual acuity (20/x)
Interval 25.0 to 50.0
|
—
|
|
Impact of Age on Visual Acuity From Baseline to 12 Months After Surgery
Month 12
|
32 visual acuity (20/x)
Interval 25.0 to 50.0
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 months (1 year) after cataract surgeryPopulation: Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Age was age at enrollment in years. Visual acuity was measured using the Tumbling-E Early Treatment Diabetic Retinopathy Study (ETDRS) protocol vision chart. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. Number of lines improvement equals the number of lines read at 12 months post cataract surgery minus the number of lines read at baseline
Outcome measures
| Measure |
EVD Survivors
n=34 eyes
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
EVD Survivors
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
|---|---|---|
|
Impact of Age on Improvement in the Number of Lines Read on an ETDRS Eye Chart From Baseline to 12 Months After Surgery
|
8.06 lines of improvement
Interval 4.01 to 20.97
|
—
|
SECONDARY outcome
Timeframe: One week prior to cataract surgeryPopulation: Zero participants were analyzed due to lack of variability in the outcome (no samples tested positive for viral persistence)
Participants undergo aqueous fluid (aqueous humor) sampling to assess for the presence of Ebola virus RNA via RT-PCR using the GeneXpert assay.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One week prior to cataract surgeryPopulation: Zero participants were analyzed due to lack of variability in the outcome (no samples tested positive for viral persistence)
Age was age at enrollment in years. Participants undergo aqueous fluid (aqueous humor) sampling to assess for the presence of Ebola virus RNA via RT-PCR using the GeneXpert assay.
Outcome measures
Outcome data not reported
Adverse Events
Control
EVD Survivors
Serious adverse events
| Measure |
Control
n=8 participants at risk
Control with clinical need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
EVD Survivors
n=22 participants at risk
EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling.
|
|---|---|---|
|
Eye disorders
Subluxed intraocular lens
|
12.5%
1/8 • Number of events 1 • Participants are monitored during all study visits, with the last visit being 12 (+/- 1.5) months from the day of surgery.
|
4.5%
1/22 • Number of events 1 • Participants are monitored during all study visits, with the last visit being 12 (+/- 1.5) months from the day of surgery.
|
|
Eye disorders
Surgery on the fellow eye
|
0.00%
0/8 • Participants are monitored during all study visits, with the last visit being 12 (+/- 1.5) months from the day of surgery.
|
4.5%
1/22 • Number of events 1 • Participants are monitored during all study visits, with the last visit being 12 (+/- 1.5) months from the day of surgery.
|
|
Eye disorders
Retinal detachment
|
12.5%
1/8 • Number of events 1 • Participants are monitored during all study visits, with the last visit being 12 (+/- 1.5) months from the day of surgery.
|
0.00%
0/22 • Participants are monitored during all study visits, with the last visit being 12 (+/- 1.5) months from the day of surgery.
|
Other adverse events
Adverse event data not reported
Additional Information
Teresa Magone, MD, Principal Investigator, NEI
National Institutes of Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place