PREVAIL VII: Cataract Surgery in Ebola Survivors
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 Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/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
- 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.
- 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
- 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
- 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.
- 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
- 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
- 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
- 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.
- 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
- 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.
- 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
- 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.
- 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
- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | PREVAIL JFK Hospital | Monrovia | Liberia |
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.- 999917167
- 17-EI-N167
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Control | EVD Survivors |
|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Control | EVD Survivors | Total |
|---|---|---|---|
| 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 Participants | 12 | 25 | 37 |
| 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
| Title | Proportion of EVD Survivors With Evidence of Persistence of Ebola Viral RNA in Ocular Tissue |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Ebola survivors in the analytic population (seropositive EVD survivors who underwent cataract surgery) |
| Arm/Group Title | EVD Survivors |
|---|---|
| Arm/Group Description | EVD survivors with need for cataract surgery Cataract surgery: Cataract surgery and aqueous humor sampling. |
| Measure Participants | 22 |
| Count of Participants [Participants] |
0
0%
|
| Title | Comparison of the Amount of Intraocular Inflammation Between EVD Survivors and Controls at 1 Month Following Cataract Surgery |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery) |
| Arm/Group Title | Control | EVD Survivors |
|---|---|---|
| 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. |
| Measure Participants | 8 | 22 |
| Measure eyes | 12 | 22 |
| 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 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 | |
| Title | Comparison of the Amount of Intraocular Inflammation Between EVD Survivors and Controls at 3 Months Following Cataract Surgery |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery) |
| Arm/Group Title | Control | EVD Survivors |
|---|---|---|
| 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. |
| Measure Participants | 8 | 22 |
| Measure eyes | 12 | 22 |
| 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 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 | |
| Title | Comparison of Proportion of Eyes With at Least 20/40 Best Corrected Visual Acuity (BCVA) 12 Months After Cataract Surgery |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery) |
| Arm/Group Title | Control | EVD Survivors |
|---|---|---|
| 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. |
| Measure Participants | 8 | 21 |
| Measure eyes | 12 | 21 |
| 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 Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.1 | |
| Confidence Interval |
(2-Sided) 95% 0.01 to 0.69 |
|
| Parameter Dispersion |
Type: Value: |
|
| 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 | |
| Title | Comparison of Intraretinal Fluid Cysts Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery) |
| Arm/Group Title | Control | EVD Survivors |
|---|---|---|
| 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. |
| Measure Participants | 8 | 22 |
| Measure eyes | 12 | 22 |
| 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 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 | |
| Title | Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery) |
| Arm/Group Title | Control | EVD Survivors |
|---|---|---|
| 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. |
| Measure Participants | 8 | 22 |
| Measure eyes | 12 | 22 |
| 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 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 | |
| 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 |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery) |
| Arm/Group Title | Control | EVD Survivors |
|---|---|---|
| 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. |
| Measure Participants | 8 | 22 |
| Measure eyes | 12 | 22 |
| 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 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 | |
| Title | Impact of Gender on Visual Acuity From Baseline to 12 Months After Surgery |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery) |
| Arm/Group Title | All Participants |
|---|---|
| Arm/Group Description | EVD Survivors and Control Participants |
| Measure Participants | 30 |
| Measure eyes | 34 |
| 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 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 | |
| Title | Impact of Gender on Improvement in the Number of Lines Read on an ETDRS Eye Chart From Baseline to 12 Months After Surgery |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery) |
| Arm/Group Title | All Participants |
|---|---|
| Arm/Group Description | EVD Survivors and Control Participants |
| Measure Participants | 30 |
| Measure eyes | 34 |
| 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 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 | |
| Title | Impact of Age on Visual Acuity From Baseline to 12 Months After Surgery |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery) |
| Arm/Group Title | All Participants |
|---|---|
| Arm/Group Description | EVD Survivors and Control Participants |
| Measure Participants | 30 |
| Measure eyes | 34 |
| 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 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 | |
| Title | Impact of Age on Improvement in the Number of Lines Read on an ETDRS Eye Chart From Baseline to 12 Months After Surgery |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery) |
| Arm/Group Title | All Participants |
|---|---|
| Arm/Group Description | EVD Survivors and Control Participants |
| Measure Participants | 30 |
| Measure eyes | 34 |
| 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 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 | |
| Title | Impact of Gender on Viral Persistence One Week Prior to Cataract Surgery |
|---|---|
| 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 |
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 Title | All Participants |
|---|---|
| Arm/Group Description | EVD Survivors and Control Participants |
| Measure Participants | 0 |
| Title | Impact of Age on Viral Persistence One Week Prior to Cataract Surgery |
|---|---|
| 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 |
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 Title | All Participants |
|---|---|
| Arm/Group Description | EVD Survivors and Control Participants |
| Measure Participants | 0 |
Adverse Events
| 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 | ||||
| Arm/Group Title | Control | EVD Survivors | ||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/8 (12.5%) | 0/22 (0%) | ||
Serious Adverse Events |
||||
| Control | EVD Survivors | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/8 (12.5%) | 2/22 (9.1%) | ||
| Eye disorders | ||||
| Subluxed intraocular lens | 1/8 (12.5%) | 1 | 1/22 (4.5%) | 1 |
| Surgery on the fellow eye | 0/8 (0%) | 0 | 1/22 (4.5%) | 1 |
| Retinal detachment | 1/8 (12.5%) | 1 | 0/22 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Control | EVD Survivors | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | 0/22 (0%) | ||
Limitations/Caveats
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/Title | Teresa Magone, MD, Principal Investigator, NEI |
|---|---|
| Organization | National Institutes of Health |
| Phone | 301-435-4562 |
| teresa.magonedequadroscosta@nih.gov |
- 999917167
- 17-EI-N167