PREVAIL VII: Cataract Surgery in Ebola Survivors

Sponsor
National Eye Institute (NEI) (NIH)
Overall Status
Completed
CT.gov ID
NCT03309020
Collaborator
(none)
37
Enrollment
1
Location
2
Arms
22.3
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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 deaths and disabling sequelae among survivors, among which eye complications are highly represented. Chronic intraocular inflammation and viral persistence may result in posterior synechiae and cataract formation, resulting in loss of visual acuity and requiring surgical intervention to resolve. Approximately one out of ten Ebola survivors present with cataract, most of whom will require intraocular surgery during their lifetime, and many of whom require intervention in the near future to regain quality of life. For survivors who are blind from cataract, cataract extraction is necessary to restore visual function, allow reintegration into society and facilitate performance of activities of daily living.

However, surgical parameters among Ebola survivors are unknown, including whether Ebola viral RNA persists in aqueous humor, whether additional anti-inflammatory medication is needed, and the expected degree of improvement in visual function. Moreover, sites of viral persistence are unknown, and it is unclear if lens tissues removed during cataract surgery may harbor virus in Ebola-affected eyes. We propose following EVD survivors and control subjects undergoing cataract surgery to determine visual outcomes among Ebola survivors and explore detection of the presence of virus in lens tissues. The data will inform both future surgical intervention and aid in the understanding of the pathophysiology of Ebola-associated eye disease.

Study Population: Up to 60 Ebola survivors and up to 60 controls will be enrolled. The accrual ceiling is 120 participants.

Design: This is a prospective, natural history study to evaluate the persistence of Ebola viral RNA in the eyes of Ebola survivors and assess the response to cataract surgery in survivors as compared to controls. EVD survivors will first undergo assessment of aqueous humor for the presence of viral RNA. Survivors testing negative for viral RNA and control subjects will undergo clinically indicated cataract surgery. Subjects will be evaluated 1 day, 1 week, 1 month, and 3, 6, 9 and 12 months after surgery for safety and visual outcome assessments, and more often as clinically indicated.

Outcome Measures: The primary outcomes are: 1) the proportion of EVD survivors with evidence of persistence of Ebola viral RNA in ocular tissue and 2) the comparison of amount of intraocular inflammation, as measured by average grade of anterior chamber cell by SUN criteria, between EVD survivors and controls at 1 month and 3 months following cataract surgery. Secondary outcomes include: 1) the proportion of survivors with at least 20/40 best corrected visual acuity (BCVA) after cataract surgery, relative to controls; 2) impact of the covariates age and gender on viral persistence and cataract outcomes; 3) post-operative optical coherence tomography results in EVD survivors.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Cataract surgery
N/A

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 deaths and disabling sequelae among survivors, among which eye complications are highly represented. Chronic intraocular inflammation and viral persistence may result in posterior synechiae and cataract formation, resulting in loss of visual acuity and requiring surgical intervention to resolve. Approximately one out of ten Ebola survivors present with cataract, most of whom will require intraocular surgery during their lifetime, and many of whom require intervention in the near future to regain quality of life. For survivors who are blind from cataract, cataract extraction is necessary to restore visual function, allow reintegration into society and facilitate performance of activities of daily living.

However, surgical parameters among Ebola survivors are unknown, including whether Ebola viral RNA persists in aqueous humor, whether additional anti-inflammatory medication is needed, and the expected degree of improvement in visual function. Moreover, sites of viral persistence are unknown, and it is unclear if lens tissues removed during cataract surgery may harbor virus in Ebola-affected eyes. We propose following EVD survivors and control subjects undergoing cataract surgery to determine visual outcomes among Ebola survivors and explore detection of the presence of virus in lens tissues. The data will inform both future surgical intervention and aid in the understanding of the pathophysiology of Ebola-associated eye disease.

Study Population: Up to 60 Ebola survivors and up to 60 controls will be enrolled. The accrual ceiling is 120 participants.

Design: This is a prospective, natural history study to evaluate the persistence of Ebola viral RNA in the eyes of Ebola survivors and assess the response to cataract surgery in survivors as compared to controls. EVD survivors will first undergo assessment of aqueous humor for the presence of viral RNA. Survivors testing negative for viral RNA and control subjects will undergo clinically indicated cataract surgery. Subjects will be evaluated 1 day, 1 week, 1 month, and 3, 6, 9 and 12 months after surgery for safety and visual outcome assessments, and more often as clinically indicated.

Outcome Measures: The primary outcomes are: 1) the proportion of EVD survivors with evidence of persistence of Ebola viral RNA in ocular tissue and 2) the comparison of amount of intraocular inflammation, as measured by average grade of anterior chamber cell by SUN criteria, between EVD survivors and controls at 1 month and 3 months following cataract surgery. Secondary outcomes include: 1) the proportion of survivors with at least 20/40 best corrected visual acuity (BCVA) after cataract surgery, relative to controls; 2) impact the of covariates, age and gender on viral persistence and cataract outcomes; 3) post-operative optical coherence tomography results in EVD survivors.

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
PREVAIL VII: Persistence of Ebola Virus in Ocular Tissues and Outcomes of Cataract Surgery in Survivors of Ebola Virus Disease
Actual Study Start Date :
Sep 21, 2017
Actual Primary Completion Date :
Jan 4, 2018
Actual Study Completion Date :
Aug 1, 2019

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Control

Control with clinical need for cataract surgery

Procedure: Cataract surgery
Cataract surgery and aqueous humor sampling.

Experimental: EVD Survivors

EVD survivors with need for cataract surgery

Procedure: Cataract surgery
Cataract surgery and aqueous humor sampling.

Outcome Measures

Primary Outcome Measures

  1. Proportion of EVD Survivors With Evidence of Persistence of Ebola Viral RNA in Ocular Tissue [One week prior to 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.

  2. Comparison of the Amount of Intraocular Inflammation Between EVD Survivors and Controls at 1 Month Following Cataract Surgery [1 month after 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

  3. Comparison of the Amount of Intraocular Inflammation Between EVD Survivors and Controls at 3 Months Following Cataract Surgery [3 months after 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

Secondary Outcome Measures

  1. Comparison of Proportion of Eyes With at Least 20/40 Best Corrected Visual Acuity (BCVA) 12 Months After Cataract Surgery [12 months (1 year) after 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.

  2. Comparison of Intraretinal Fluid Cysts Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery [Baseline to 12 months (1 year) after 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

  3. Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery [Baseline to 12 months (1 year) after 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

  4. 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 to 12 months (1 year) after 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

  5. Impact of Gender on Visual Acuity From Baseline to 12 Months After Surgery [Baseline to 12 months (1 year) after 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.

  6. Impact of Gender on Improvement in the Number of Lines Read on an ETDRS Eye Chart From Baseline to 12 Months After Surgery [Baseline to 12 months (1 year) after 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

  7. Impact of Age on Visual Acuity From Baseline to 12 Months After Surgery [Baseline to 12 months (1 year) after 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.

  8. Impact of Age on Improvement in the Number of Lines Read on an ETDRS Eye Chart From Baseline to 12 Months After Surgery [Baseline to 12 months (1 year) after 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

  9. Impact of Gender on Viral Persistence One Week Prior to Cataract Surgery [One week prior to 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.

  10. Impact of Age on Viral Persistence One Week Prior to Cataract Surgery [One week prior to cataract surgery]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
  • 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.).

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

  2. 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.

  3. 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1PREVAIL JFK HospitalMonroviaLiberia

Sponsors and Collaborators

  • National Eye Institute (NEI)

Investigators

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

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
National Eye Institute (NEI)
ClinicalTrials.gov Identifier:
NCT03309020
Other Study ID Numbers:
  • 999917167
  • 17-EI-N167
First Posted:
Oct 13, 2017
Last Update Posted:
Jun 29, 2021
Last Verified:
Aug 18, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Eye Institute (NEI)
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleControlEVD Survivors
Arm/Group DescriptionControl 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
STARTED1225
Underwent Cataract Surgery1024
COMPLETED924
NOT COMPLETED31

Baseline Characteristics

Arm/Group TitleControlEVD SurvivorsTotal
Arm/Group DescriptionControl 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 Participants122537
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]
56
62
59
Sex: Female, Male (Count of Participants)
Female
6
50%
14
56%
20
54.1%
Male
6
50%
11
44%
17
45.9%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%
Region of Enrollment (participants) [Number]
Liberia
12
100%
25
100%
37
100%

Outcome Measures

1. Primary Outcome
TitleProportion of EVD Survivors With Evidence of Persistence of Ebola Viral RNA in Ocular Tissue
DescriptionParticipants 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 FrameOne week prior to cataract surgery

Outcome Measure Data

Analysis Population Description
Ebola survivors in the analytic population (seropositive EVD survivors who underwent cataract surgery)
Arm/Group TitleEVD Survivors
Arm/Group DescriptionEVD survivors with need for cataract surgery Cataract surgery: Cataract surgery and aqueous humor sampling.
Measure Participants22
Count of Participants [Participants]
0
0%
2. Primary Outcome
TitleComparison of the Amount of Intraocular Inflammation Between EVD Survivors and Controls at 1 Month Following Cataract Surgery
DescriptionThe 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 Frame1 month after cataract surgery

Outcome Measure Data

Analysis Population Description
Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Arm/Group TitleControlEVD Survivors
Arm/Group DescriptionControl 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.
Measure Participants822
Measure eyes1222
Mean (Standard Deviation) [AC cell grade]
.67
(.49)
.64
(.66)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EVD Survivors, EVD Survivors
Comments Null hypothesis is no difference in grade between survivor statuses one month after cataract surgery
Type of Statistical Test Other
Comments
Statistical Test of Hypothesisp-Value0.802
CommentsThe threshold for statistical significance was p = 0.05
MethodMixed Models Analysis
CommentsAge at enrollment and gender (male or female) were included as covariates in the model
3. Primary Outcome
TitleComparison of the Amount of Intraocular Inflammation Between EVD Survivors and Controls at 3 Months Following Cataract Surgery
DescriptionThe 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 Frame3 months after cataract surgery

Outcome Measure Data

Analysis Population Description
Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Arm/Group TitleControlEVD Survivors
Arm/Group DescriptionControl 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.
Measure Participants822
Measure eyes1222
Mean (Standard Deviation) [AC cell grade]
.5
(1.17)
.82
(1.01)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EVD Survivors, EVD Survivors
Comments Null hypothesis is no difference in grade between survivor statuses three months after cataract surgery
Type of Statistical Test Other
Comments
Statistical Test of Hypothesisp-Value.713
CommentsThe threshold for statistical significance was p = 0.05
MethodMixed Models Analysis
CommentsAge at enrollment and gender (male or female) were included as covariates in the model
4. Secondary Outcome
TitleComparison of Proportion of Eyes With at Least 20/40 Best Corrected Visual Acuity (BCVA) 12 Months After Cataract Surgery
DescriptionComparison 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 Frame12 months (1 year) after cataract surgery

Outcome Measure Data

Analysis Population Description
Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Arm/Group TitleControlEVD Survivors
Arm/Group DescriptionControl 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.
Measure Participants821
Measure eyes1221
Count of Units [eyes]
5
18
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EVD Survivors, 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
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterOdds Ratio (OR)
Estimated Value0.1
Confidence Interval (2-Sided) 95%
0.01 to 0.69
Parameter Dispersion Type:
Value:
Estimation CommentsOdds 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
TitleComparison of Intraretinal Fluid Cysts Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery
DescriptionOptical 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 FrameBaseline to 12 months (1 year) after cataract surgery

Outcome Measure Data

Analysis Population Description
Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Arm/Group TitleControlEVD Survivors
Arm/Group DescriptionControl 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.
Measure Participants822
Measure eyes1222
Baseline
0
0
Month 1
0
0
Month 3
1
3
Month 6
0
1
Month 9
1
2
Month 12
2
2
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EVD Survivors, EVD Survivors
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesisp-Value.832
CommentsThe threshold for statistical significance was p = 0.05
MethodMixed Models Analysis
CommentsAge at enrollment and gender (male or female) were included as covariates in the model
6. Secondary Outcome
TitleComparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery
DescriptionOptical 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 FrameBaseline to 12 months (1 year) after cataract surgery

Outcome Measure Data

Analysis Population Description
Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Arm/Group TitleControlEVD Survivors
Arm/Group DescriptionControl 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.
Measure Participants822
Measure eyes1222
Baseline
203
209
Month 1
222
224
Month 3
227
216
Month 6
226.5
234
Month 9
240
238
Month 12
244
231
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EVD Survivors, EVD Survivors
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesisp-Value.995
CommentsThe threshold for statistical significance was p = 0.05
MethodMixed Models Analysis
CommentsAge at enrollment and gender (male or female) were included as covariates in the model
7. Secondary Outcome
TitleComparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls, Excluding Cases of Intraretinal Fluid Cysts, From Baseline to 12 Months After Cataract Surgery
DescriptionOptical 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 FrameBaseline to 12 months (1 year) after cataract surgery

Outcome Measure Data

Analysis Population Description
Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Arm/Group TitleControlEVD Survivors
Arm/Group DescriptionControl 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.
Measure Participants822
Measure eyes1222
Baseline
203
218
Month 1
222
224
Month 3
223
214
Month 6
220
229
Month 9
240
238
Month 12
242
231
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EVD Survivors, EVD Survivors
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesisp-Value0.441
CommentsThe threshold for statistical significance was p = 0.05
MethodMixed Models Analysis
CommentsAge at enrollment and gender (male or female) were included as covariates in the model
8. Secondary Outcome
TitleImpact of Gender on Visual Acuity From Baseline to 12 Months After Surgery
DescriptionVisual 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 FrameBaseline to 12 months (1 year) after cataract surgery

Outcome Measure Data

Analysis Population Description
Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Arm/Group TitleAll Participants
Arm/Group DescriptionEVD Survivors and Control Participants
Measure Participants30
Measure eyes34
Baseline
800
Month 1
40
Month 12
32
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EVD Survivors
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesisp-Value.892
CommentsThe threshold for statistical significance was p = 0.05
MethodMixed Models Analysis
CommentsAge at enrollment, survivor status (EVD survivor/control) included as covariates; within-subject measurement of distinct eyes treated as independent
9. Secondary Outcome
TitleImpact of Gender on Improvement in the Number of Lines Read on an ETDRS Eye Chart From Baseline to 12 Months After Surgery
DescriptionVisual 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 FrameBaseline to 12 months (1 year) after cataract surgery

Outcome Measure Data

Analysis Population Description
Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Arm/Group TitleAll Participants
Arm/Group DescriptionEVD Survivors and Control Participants
Measure Participants30
Measure eyes34
Median (Inter-Quartile Range) [lines of improvement]
8.06
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EVD Survivors
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesisp-Value.913
CommentsThe threshold for statistical significance was p = 0.05
MethodMixed Models Analysis
CommentsAge at enrollment, survivor status (EVD survivor/control) included as covariates; within-subject measurement of distinct eyes treated as independent
10. Secondary Outcome
TitleImpact of Age on Visual Acuity From Baseline to 12 Months After Surgery
DescriptionAge 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 FrameBaseline to 12 months (1 year) after cataract surgery

Outcome Measure Data

Analysis Population Description
Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Arm/Group TitleAll Participants
Arm/Group DescriptionEVD Survivors and Control Participants
Measure Participants30
Measure eyes34
Baseline
800
Month 1
40
Month 12
32
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EVD Survivors
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesisp-Value.106
CommentsThe threshold for statistical significance was p = 0.05
MethodMixed Models Analysis
CommentsGender (male/female), survivor status (EVD survivor/control) as covariates; within-subject measurement of distinct eyes treated as independent
11. Secondary Outcome
TitleImpact of Age on Improvement in the Number of Lines Read on an ETDRS Eye Chart From Baseline to 12 Months After Surgery
DescriptionAge 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 FrameBaseline to 12 months (1 year) after cataract surgery

Outcome Measure Data

Analysis Population Description
Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
Arm/Group TitleAll Participants
Arm/Group DescriptionEVD Survivors and Control Participants
Measure Participants30
Measure eyes34
Median (Inter-Quartile Range) [lines of improvement]
8.06
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EVD Survivors
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesisp-Value0.09
CommentsThe threshold for statistical significance was p = 0.05
MethodMixed Models Analysis
CommentsGender (male/female), survivor status (EVD survivor/control) as covariates; within-subject measurement of distinct eyes treated as independent
12. Secondary Outcome
TitleImpact of Gender on Viral Persistence One Week Prior to Cataract Surgery
DescriptionParticipants undergo aqueous fluid (aqueous humor) sampling to assess for the presence of Ebola virus RNA via RT-PCR using the GeneXpert assay.
Time FrameOne week prior to cataract surgery

Outcome Measure Data

Analysis Population Description
Zero participants were analyzed due to lack of variability in the outcome (no samples tested positive for viral persistence)
Arm/Group TitleAll Participants
Arm/Group DescriptionEVD Survivors and Control Participants
Measure Participants0
13. Secondary Outcome
TitleImpact of Age on Viral Persistence One Week Prior to Cataract Surgery
DescriptionAge 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 FrameOne week prior to cataract surgery

Outcome Measure Data

Analysis Population Description
Zero participants were analyzed due to lack of variability in the outcome (no samples tested positive for viral persistence)
Arm/Group TitleAll Participants
Arm/Group DescriptionEVD Survivors and Control Participants
Measure Participants0

Adverse Events

Time FrameParticipants are monitored during all study visits, with the last visit being 12 (+/- 1.5) months from the day of surgery.
Adverse Event Reporting Description
Arm/Group TitleControlEVD Survivors
Arm/Group DescriptionControl 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
ControlEVD Survivors
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total1/8 (12.5%) 0/22 (0%)
Serious Adverse Events
ControlEVD Survivors
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total1/8 (12.5%) 2/22 (9.1%)
Eye disorders
Subluxed intraocular lens1/8 (12.5%) 11/22 (4.5%) 1
Surgery on the fellow eye0/8 (0%) 01/22 (4.5%) 1
Retinal detachment1/8 (12.5%) 10/22 (0%) 0
Other (Not Including Serious) Adverse Events
ControlEVD Survivors
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/8 (0%) 0/22 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleTeresa Magone, MD, Principal Investigator, NEI
OrganizationNational Institutes of Health
Phone301-435-4562
Emailteresa.magonedequadroscosta@nih.gov
Responsible Party:
National Eye Institute (NEI)
ClinicalTrials.gov Identifier:
NCT03309020
Other Study ID Numbers:
  • 999917167
  • 17-EI-N167
First Posted:
Oct 13, 2017
Last Update Posted:
Jun 29, 2021
Last Verified:
Aug 18, 2020