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PREVAIL VII: Cataract Surgery in Ebola Survivors

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ClinicalTrials.gov Identifier: NCT03309020
Recruitment Status : Completed
First Posted : October 13, 2017
Results First Posted : June 29, 2021
Last Update Posted : June 29, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cataract
Intervention Procedure: Cataract surgery
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control EVD Survivors
Hide Arm/Group Description

Control with clinical need for cataract surgery

Cataract surgery: Cataract surgery and aqueous humor sampling.

EVD survivors with need for cataract surgery

Cataract surgery: Cataract surgery and aqueous humor sampling.

Period Title: Overall Study
Started 12 25
Underwent Cataract Surgery 10 24
Completed 9 24
Not Completed 3 1
Reason Not Completed
Death             1             0
Did not undergo surgery             2             1
Arm/Group Title Control EVD Survivors Total
Hide Arm/Group Description

Control with clinical need for cataract surgery

Cataract surgery: Cataract surgery and aqueous humor sampling.

EVD survivors with need for cataract surgery

Cataract surgery: Cataract surgery and aqueous humor sampling.

Total of all reporting groups
Overall Number of Baseline Participants 12 25 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 12 participants 25 participants 37 participants
56
(40 to 63.8)
62
(40 to 68)
59
(40 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 25 participants 37 participants
Female
6
  50.0%
14
  56.0%
20
  54.1%
Male
6
  50.0%
11
  44.0%
17
  45.9%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Liberia Number Analyzed 12 participants 25 participants 37 participants
12 25 37
1.Primary Outcome
Title Proportion of EVD Survivors With Evidence of Persistence of Ebola Viral RNA in Ocular Tissue
Hide Description

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.

Time Frame One week prior to cataract surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Ebola survivors in the analytic population (seropositive EVD survivors who underwent cataract surgery)
Arm/Group Title EVD Survivors
Hide Arm/Group Description:

EVD survivors with need for cataract surgery

Cataract surgery: Cataract surgery and aqueous humor sampling.

Overall Number of Participants Analyzed 22
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Primary Outcome
Title Comparison of the Amount of Intraocular Inflammation Between EVD Survivors and Controls at 1 Month Following Cataract Surgery
Hide Description

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

Time Frame 1 month after cataract surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Arm/Group Title Control EVD Survivors
Hide Arm/Group Description:

Control with clinical need for cataract surgery

Cataract surgery: Cataract surgery and aqueous humor sampling.

EVD survivors with need for cataract surgery

Cataract surgery: Cataract surgery and aqueous humor sampling.

Overall Number of Participants Analyzed 8 22
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
12 22
Mean (Standard Deviation)
Unit of Measure: AC cell grade
.67  (.49) .64  (.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, EVD Survivors
Comments Null hypothesis is no difference in grade between survivor statuses one month after cataract surgery
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.802
Comments The threshold for statistical significance was p = 0.05
Method Mixed Models Analysis
Comments Age at enrollment and gender (male or female) were included as covariates in the model
3.Primary Outcome
Title Comparison of the Amount of Intraocular Inflammation Between EVD Survivors and Controls at 3 Months Following Cataract Surgery
Hide Description

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

Time Frame 3 months after cataract surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Arm/Group Title Control EVD Survivors
Hide Arm/Group Description:

Control with clinical need for cataract surgery

Cataract surgery: Cataract surgery and aqueous humor sampling.

EVD survivors with need for cataract surgery

Cataract surgery: Cataract surgery and aqueous humor sampling.

Overall Number of Participants Analyzed 8 22
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
12 22
Mean (Standard Deviation)
Unit of Measure: AC cell grade
.5  (1.17) .82  (1.01)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, EVD Survivors
Comments Null hypothesis is no difference in grade between survivor statuses three months after cataract surgery
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .713
Comments The threshold for statistical significance was p = 0.05
Method Mixed Models Analysis
Comments Age at enrollment and gender (male or female) were included as covariates in the model
4.Secondary Outcome
Title Comparison of Proportion of Eyes With at Least 20/40 Best Corrected Visual Acuity (BCVA) 12 Months After Cataract Surgery
Hide Description 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.
Time Frame 12 months (1 year) after cataract surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Arm/Group Title Control EVD Survivors
Hide Arm/Group Description:

Control with clinical need for cataract surgery

Cataract surgery: Cataract surgery and aqueous humor sampling.

EVD survivors with need for cataract surgery

Cataract surgery: Cataract surgery and aqueous humor sampling.

Overall Number of Participants Analyzed 8 21
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
12 21
Count of Units
Unit of Measure: eyes
5
  41.7%
18
  85.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, EVD Survivors
Comments Null hypothesis is no difference in the proportion of participants with at least 20/40 best corrected visual acuity (BCVA) between survivor statuses
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
0.01 to 0.69
Estimation Comments Odds of eye with at least 20/40 best corrected visual acuity (BCVA) 12 months after cataract surgery for controls vs. EVD survivors
5.Secondary Outcome
Title Comparison of Intraretinal Fluid Cysts Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery
Hide Description 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
Time Frame Baseline to 12 months (1 year) after cataract surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Arm/Group Title Control EVD Survivors
Hide Arm/Group Description:

Control with clinical need for cataract surgery

Cataract surgery: Cataract surgery and aqueous humor sampling.

EVD survivors with need for cataract surgery

Cataract surgery: Cataract surgery and aqueous humor sampling.

Overall Number of Participants Analyzed 8 22
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
12 22
Measure Type: Number
Unit of Measure: eyes
Baseline 0 0
Month 1 0 0
Month 3 1 3
Month 6 0 1
Month 9 1 2
Month 12 2 2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, EVD Survivors
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .832
Comments The threshold for statistical significance was p = 0.05
Method Mixed Models Analysis
Comments Age at enrollment and gender (male or female) were included as covariates in the model
6.Secondary Outcome
Title Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery
Hide Description 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
Time Frame Baseline to 12 months (1 year) after cataract surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Arm/Group Title Control EVD Survivors
Hide Arm/Group Description:

Control with clinical need for cataract surgery

Cataract surgery: Cataract surgery and aqueous humor sampling.

EVD survivors with need for cataract surgery

Cataract surgery: Cataract surgery and aqueous humor sampling.

Overall Number of Participants Analyzed 8 22
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
12 22
Median (Inter-Quartile Range)
Unit of Measure: µm
Baseline
203
(182 to 204)
209
(184 to 244.5)
Month 1
222
(217.5 to 260)
224
(211 to 269.5)
Month 3
227
(196.8 to 260.2)
216
(188 to 253)
Month 6
226.5
(209.5 to 234.8)
234
(203 to 258)
Month 9
240
(227.8 to 258.2)
238
(214 to 254.5)
Month 12
244
(221.5 to 264.5)
231
(212.5 to 245.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, EVD Survivors
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .995
Comments The threshold for statistical significance was p = 0.05
Method Mixed Models Analysis
Comments Age at enrollment and gender (male or female) were included as covariates in the model
7.Secondary Outcome
Title 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
Hide Description 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
Time Frame Baseline to 12 months (1 year) after cataract surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Arm/Group Title Control EVD Survivors
Hide Arm/Group Description:

Control with clinical need for cataract surgery

Cataract surgery: Cataract surgery and aqueous humor sampling.

EVD survivors with need for cataract surgery

Cataract surgery: Cataract surgery and aqueous humor sampling.

Overall Number of Participants Analyzed 8 22
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
12 22
Median (Inter-Quartile Range)
Unit of Measure: µm
Baseline
203
(182 to 204)
218
(190.2 to 244)
Month 1
222
(217.5 to 260)
224
(211 to 269.5)
Month 3
223
(196.5 to 248)
214
(183.5 to 224)
Month 6
220
(207 to 234)
229
(202.8 to 251.2)
Month 9
240
(225.5 to 253)
238
(211 to 254)
Month 12
242
(211 to 248)
231
(216 to 244)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, EVD Survivors
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.441
Comments The threshold for statistical significance was p = 0.05
Method Mixed Models Analysis
Comments Age at enrollment and gender (male or female) were included as covariates in the model
8.Secondary Outcome
Title Impact of Gender on Visual Acuity From Baseline to 12 Months After Surgery
Hide Description 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.
Time Frame Baseline to 12 months (1 year) after cataract surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Arm/Group Title All Participants
Hide Arm/Group Description:
EVD Survivors and Control Participants
Overall Number of Participants Analyzed 30
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
34
Median (Inter-Quartile Range)
Unit of Measure: visual acuity (20/x)
Baseline
800
(100 to 4000)
Month 1
40
(25 to 50)
Month 12
32
(25 to 50)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .892
Comments The threshold for statistical significance was p = 0.05
Method Mixed Models Analysis
Comments Age at enrollment, survivor status (EVD survivor/control) included as covariates; within-subject measurement of distinct eyes treated as independent
9.Secondary Outcome
Title Impact of Gender on Improvement in the Number of Lines Read on an ETDRS Eye Chart From Baseline to 12 Months After Surgery
Hide Description 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
Time Frame Baseline to 12 months (1 year) after cataract surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Arm/Group Title All Participants
Hide Arm/Group Description:
EVD Survivors and Control Participants
Overall Number of Participants Analyzed 30
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
34
Median (Inter-Quartile Range)
Unit of Measure: lines of improvement
8.06
(4.01 to 20.97)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .913
Comments The threshold for statistical significance was p = 0.05
Method Mixed Models Analysis
Comments Age at enrollment, survivor status (EVD survivor/control) included as covariates; within-subject measurement of distinct eyes treated as independent
10.Secondary Outcome
Title Impact of Age on Visual Acuity From Baseline to 12 Months After Surgery
Hide Description 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.
Time Frame Baseline to 12 months (1 year) after cataract surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Arm/Group Title All Participants
Hide Arm/Group Description:
EVD Survivors and Control Participants
Overall Number of Participants Analyzed 30
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
34
Median (Inter-Quartile Range)
Unit of Measure: visual acuity (20/x)
Baseline
800
(100 to 4000)
Month 1
40
(25 to 50)
Month 12
32
(25 to 50)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .106
Comments The threshold for statistical significance was p = 0.05
Method Mixed Models Analysis
Comments Gender (male/female), survivor status (EVD survivor/control) as covariates; within-subject measurement of distinct eyes treated as independent
11.Secondary Outcome
Title Impact of Age on Improvement in the Number of Lines Read on an ETDRS Eye Chart From Baseline to 12 Months After Surgery
Hide Description 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
Time Frame Baseline to 12 months (1 year) after cataract surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Arm/Group Title All Participants
Hide Arm/Group Description:
EVD Survivors and Control Participants
Overall Number of Participants Analyzed 30
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
34
Median (Inter-Quartile Range)
Unit of Measure: lines of improvement
8.06
(4.01 to 20.97)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments The threshold for statistical significance was p = 0.05
Method Mixed Models Analysis
Comments Gender (male/female), survivor status (EVD survivor/control) as covariates; within-subject measurement of distinct eyes treated as independent
12.Secondary Outcome
Title Impact of Gender on Viral Persistence One Week Prior to Cataract Surgery
Hide Description Participants undergo aqueous fluid (aqueous humor) sampling to assess for the presence of Ebola virus RNA via RT-PCR using the GeneXpert assay.
Time Frame One week prior to cataract surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed due to lack of variability in the outcome (no samples tested positive for viral persistence)
Arm/Group Title All Participants
Hide Arm/Group Description:
EVD Survivors and Control Participants
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Impact of Age on Viral Persistence One Week Prior to Cataract Surgery
Hide Description 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.
Time Frame One week prior to cataract surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed due to lack of variability in the outcome (no samples tested positive for viral persistence)
Arm/Group Title All Participants
Hide Arm/Group Description:
EVD Survivors and Control Participants
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Participants are monitored during all study visits, with the last visit being 12 (+/- 1.5) months from the day of surgery.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control EVD Survivors
Hide Arm/Group Description

Control with clinical need for cataract surgery

Cataract surgery: Cataract surgery and aqueous humor sampling.

EVD survivors with need for cataract surgery

Cataract surgery: Cataract surgery and aqueous humor sampling.

All-Cause Mortality
Control EVD Survivors
Affected / at Risk (%) Affected / at Risk (%)
Total   1/8 (12.50%)      0/22 (0.00%)    
Hide Serious Adverse Events
Control EVD Survivors
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/8 (12.50%)      2/22 (9.09%)    
Eye disorders     
Subluxed intraocular lens  [1]  1/8 (12.50%)  1 1/22 (4.55%)  1
Surgery on the fellow eye   0/8 (0.00%)  0 1/22 (4.55%)  1
Retinal detachment  [2]  1/8 (12.50%)  1 0/22 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Subluxed intraocular lens with secondary anterior chambers lens placement at lens epithelial cell
[2]
Inferior rhegmatogenous retinal detachment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control EVD Survivors
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/22 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Teresa Magone, MD, Principal Investigator, NEI
Organization: National Institutes of Health
Phone: 301-435-4562
EMail: teresa.magonedequadroscosta@nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )
ClinicalTrials.gov Identifier: NCT03309020    
Other Study ID Numbers: 999917167
17-EI-N167
First Submitted: October 12, 2017
First Posted: October 13, 2017
Results First Submitted: June 7, 2021
Results First Posted: June 29, 2021
Last Update Posted: June 29, 2021