Cataract
Conditions
Keywords
OCT, Cataracts, Visual Acuity
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.
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.
Interventions
PROCEDURECataract surgery
Cataract surgery and aqueous humor sampling.
Sponsors
National Eye Institute (NEI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* INCLUSION CRITERIA: To be eligible, the following inclusion criteria must be met, where applicable. 1. Participant must be 14 years of age or older. 2. Participant must be able to understand and sign an informed consent or have a parent/legal guardian do so if they are minor children or a legally authorized representative to provide consent for adults without consent capacity. 3. Participant must be either: * an Ebola virus disease (EVD) seropositive survivor or seropositive control OR * an EVD seronegative survivor or seronegative control (Serology confirmation is available for PREVAIL participants and will be conducted for non-PREVAIL participants.). 4. Participant must have visually significant cataract(s) consistent with level of visual deficit. 5. Participant must have corrected visual acuity worse than 20/40 in affected eye and vision loss believed to be primarily the result of the cataract. 6. Any woman and persons of childbearing potential age have a negative pregnancy test at screening and must be willing to undergo pregnancy testing prior to the cataract surgery.
Exclusion criteria
A participant is not eligible if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| 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. |
| 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 |
Countries
Liberia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Control with clinical need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling. | 12 |
| EVD Survivors EVD survivors with need for cataract surgery
Cataract surgery: Cataract surgery and aqueous humor sampling. | 25 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Did not undergo surgery | 2 | 1 |
Baseline characteristics
| Characteristic | EVD Survivors | Control | Total |
|---|---|---|---|
| Age, Continuous | 62 years | 56 years | 59 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Liberia | 25 participants | 12 participants | 37 participants |
| Sex: Female, Male Female | 14 Participants | 6 Participants | 20 Participants |
| Sex: Female, Male Male | 11 Participants | 6 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 8 | 0 / 22 |
| other Total, other adverse events | 0 / 8 | 0 / 22 |
| serious Total, serious adverse events | 1 / 8 | 2 / 22 |
Outcome results
Primary
Comparison of the Amount of Intraocular Inflammation Between EVD Survivors and Controls at 1 Month Following 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
Time frame: 1 month after cataract surgery
Population: Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EVD Survivors | Comparison of the Amount of Intraocular Inflammation Between EVD Survivors and Controls at 1 Month Following Cataract Surgery | .67 AC cell grade | Standard Deviation 0.49 |
| EVD Survivors | Comparison of the Amount of Intraocular Inflammation Between EVD Survivors and Controls at 1 Month Following Cataract Surgery | .64 AC cell grade | Standard Deviation 0.66 |
Comparison: Null hypothesis is no difference in grade between survivor statuses one month after cataract surgeryp-value: 0.802Mixed Models Analysis
Primary
Comparison of the Amount of Intraocular Inflammation Between EVD Survivors and Controls at 3 Months Following 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
Time frame: 3 months after cataract surgery
Population: Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EVD Survivors | Comparison of the Amount of Intraocular Inflammation Between EVD Survivors and Controls at 3 Months Following Cataract Surgery | .5 AC cell grade | Standard Deviation 1.17 |
| EVD Survivors | Comparison of the Amount of Intraocular Inflammation Between EVD Survivors and Controls at 3 Months Following Cataract Surgery | .82 AC cell grade | Standard Deviation 1.01 |
Comparison: Null hypothesis is no difference in grade between survivor statuses three months after cataract surgeryp-value: 0.713Mixed Models Analysis
Primary
Proportion of EVD Survivors With Evidence of Persistence of Ebola Viral RNA in Ocular Tissue
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
Population: Ebola survivors in the analytic population (seropositive EVD survivors who underwent cataract surgery)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EVD Survivors | Proportion of EVD Survivors With Evidence of Persistence of Ebola Viral RNA in Ocular Tissue | 0 Participants |
Secondary
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
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
Population: Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EVD Survivors | Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls, Excluding Cases of Intraretinal Fluid Cysts, From Baseline to 12 Months After Cataract Surgery | Baseline | 203 µm |
| EVD Survivors | Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls, Excluding Cases of Intraretinal Fluid Cysts, From Baseline to 12 Months After Cataract Surgery | Month 1 | 222 µm |
| EVD Survivors | Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls, Excluding Cases of Intraretinal Fluid Cysts, From Baseline to 12 Months After Cataract Surgery | Month 3 | 223 µm |
| EVD Survivors | Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls, Excluding Cases of Intraretinal Fluid Cysts, From Baseline to 12 Months After Cataract Surgery | Month 6 | 220 µm |
| EVD Survivors | Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls, Excluding Cases of Intraretinal Fluid Cysts, From Baseline to 12 Months After Cataract Surgery | Month 9 | 240 µm |
| EVD Survivors | Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls, Excluding Cases of Intraretinal Fluid Cysts, From Baseline to 12 Months After Cataract Surgery | Month 12 | 242 µm |
| EVD Survivors | Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls, Excluding Cases of Intraretinal Fluid Cysts, From Baseline to 12 Months After Cataract Surgery | Month 9 | 238 µm |
| EVD Survivors | 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 | 218 µm |
| EVD Survivors | Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls, Excluding Cases of Intraretinal Fluid Cysts, From Baseline to 12 Months After Cataract Surgery | Month 6 | 229 µm |
| EVD Survivors | Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls, Excluding Cases of Intraretinal Fluid Cysts, From Baseline to 12 Months After Cataract Surgery | Month 1 | 224 µm |
| EVD Survivors | Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls, Excluding Cases of Intraretinal Fluid Cysts, From Baseline to 12 Months After Cataract Surgery | Month 12 | 231 µm |
| EVD Survivors | Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls, Excluding Cases of Intraretinal Fluid Cysts, From Baseline to 12 Months After Cataract Surgery | Month 3 | 214 µm |
p-value: 0.441Mixed Models Analysis
Secondary
Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls From Baseline to 12 Months 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
Time frame: Baseline to 12 months (1 year) after cataract surgery
Population: Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EVD Survivors | Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery | Baseline | 203 µm |
| EVD Survivors | Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery | Month 1 | 222 µm |
| EVD Survivors | Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery | Month 3 | 227 µm |
| EVD Survivors | Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery | Month 6 | 226.5 µm |
| EVD Survivors | Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery | Month 9 | 240 µm |
| EVD Survivors | Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery | Month 12 | 244 µm |
| EVD Survivors | Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery | Month 9 | 238 µm |
| EVD Survivors | Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery | Baseline | 209 µm |
| EVD Survivors | Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery | Month 6 | 234 µm |
| EVD Survivors | Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery | Month 1 | 224 µm |
| EVD Survivors | Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery | Month 12 | 231 µm |
| EVD Survivors | Comparison of Central Subfield Thickness (CST) Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery | Month 3 | 216 µm |
p-value: 0.995Mixed Models Analysis
Secondary
Comparison of Intraretinal Fluid Cysts Between EVD Survivors and Controls From Baseline to 12 Months 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
Time frame: Baseline to 12 months (1 year) after cataract surgery
Population: Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EVD Survivors | Comparison of Intraretinal Fluid Cysts Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery | Baseline | 0 eyes |
| EVD Survivors | Comparison of Intraretinal Fluid Cysts Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery | Month 1 | 0 eyes |
| EVD Survivors | Comparison of Intraretinal Fluid Cysts Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery | Month 3 | 1 eyes |
| EVD Survivors | Comparison of Intraretinal Fluid Cysts Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery | Month 6 | 0 eyes |
| EVD Survivors | Comparison of Intraretinal Fluid Cysts Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery | Month 9 | 1 eyes |
| EVD Survivors | Comparison of Intraretinal Fluid Cysts Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery | Month 12 | 2 eyes |
| EVD Survivors | Comparison of Intraretinal Fluid Cysts Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery | Month 9 | 2 eyes |
| EVD Survivors | Comparison of Intraretinal Fluid Cysts Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery | Baseline | 0 eyes |
| EVD Survivors | Comparison of Intraretinal Fluid Cysts Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery | Month 6 | 1 eyes |
| EVD Survivors | Comparison of Intraretinal Fluid Cysts Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery | Month 1 | 0 eyes |
| EVD Survivors | Comparison of Intraretinal Fluid Cysts Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery | Month 12 | 2 eyes |
| EVD Survivors | Comparison of Intraretinal Fluid Cysts Between EVD Survivors and Controls From Baseline to 12 Months After Cataract Surgery | Month 3 | 3 eyes |
p-value: 0.832Mixed Models Analysis
Secondary
Comparison of Proportion of Eyes With at Least 20/40 Best Corrected Visual Acuity (BCVA) 12 Months 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.
Time frame: 12 months (1 year) after cataract surgery
Population: Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| EVD Survivors | Comparison of Proportion of Eyes With at Least 20/40 Best Corrected Visual Acuity (BCVA) 12 Months After Cataract Surgery | 5 eyes |
| EVD Survivors | Comparison of Proportion of Eyes With at Least 20/40 Best Corrected Visual Acuity (BCVA) 12 Months After Cataract Surgery | 18 eyes |
Comparison: Null hypothesis is no difference in the proportion of participants with at least 20/40 best corrected visual acuity (BCVA) between survivor statuses95% CI: [0.01, 0.69]
Secondary
Impact of Age on Improvement in the Number of Lines Read on an ETDRS Eye Chart From Baseline to 12 Months After 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
Time frame: Baseline to 12 months (1 year) after cataract surgery
Population: Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EVD Survivors | Impact of Age on Improvement in the Number of Lines Read on an ETDRS Eye Chart From Baseline to 12 Months After Surgery | 8.06 lines of improvement |
p-value: 0.09Mixed Models Analysis
Secondary
Impact of Age on Viral Persistence 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.
Time frame: One week prior to cataract surgery
Population: Zero participants were analyzed due to lack of variability in the outcome (no samples tested positive for viral persistence)
Secondary
Impact of Age on Visual Acuity From Baseline to 12 Months After 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.
Time frame: Baseline to 12 months (1 year) after cataract surgery
Population: Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EVD Survivors | Impact of Age on Visual Acuity From Baseline to 12 Months After Surgery | Baseline | 800 visual acuity (20/x) |
| EVD Survivors | Impact of Age on Visual Acuity From Baseline to 12 Months After Surgery | Month 1 | 40 visual acuity (20/x) |
| EVD Survivors | Impact of Age on Visual Acuity From Baseline to 12 Months After Surgery | Month 12 | 32 visual acuity (20/x) |
p-value: 0.106Mixed Models Analysis
Secondary
Impact of Gender on Improvement in the Number of Lines Read on an ETDRS Eye Chart From Baseline to 12 Months After 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
Time frame: Baseline to 12 months (1 year) after cataract surgery
Population: Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EVD Survivors | Impact of Gender on Improvement in the Number of Lines Read on an ETDRS Eye Chart From Baseline to 12 Months After Surgery | 8.06 lines of improvement |
p-value: 0.913Mixed Models Analysis
Secondary
Impact of Gender on Viral Persistence 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.
Time frame: One week prior to cataract surgery
Population: Zero participants were analyzed due to lack of variability in the outcome (no samples tested positive for viral persistence)
Secondary
Impact of Gender on Visual Acuity From Baseline to 12 Months After 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.
Time frame: Baseline to 12 months (1 year) after cataract surgery
Population: Analytic population (seropositive EVD survivors and seronegative controls who underwent cataract surgery)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EVD Survivors | Impact of Gender on Visual Acuity From Baseline to 12 Months After Surgery | Baseline | 800 visual acuity (20/x) |
| EVD Survivors | Impact of Gender on Visual Acuity From Baseline to 12 Months After Surgery | Month 1 | 40 visual acuity (20/x) |
| EVD Survivors | Impact of Gender on Visual Acuity From Baseline to 12 Months After Surgery | Month 12 | 32 visual acuity (20/x) |
p-value: 0.892Mixed Models Analysis