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| ID | Type | Description | Link |
|---|---|---|---|
| UG1EY025992 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Orbis | OTHER |
| National Eye Institute (NEI) | NIH |
| University of Maryland, Baltimore | OTHER |
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The purpose of this study is to determine whether the rate of post-operative trachomatous trichiasis differs significantly between bilamellar tarsal rotation surgery with an incision height of 3 mm, bilamellar tarsal rotation surgery with an incision height of 5 mm, and Trabut surgery.
In this trial the investigators will randomize 4,953 individuals with previously unoperated trichiasis on a 1:1:1 basis to bilamellar tarsal rotation trichiasis surgery with an incision height of 3 mm, bilamellar tarsal rotation trichiasis surgery with an incision height of 5 mm, or Trabut surgery. Participants will receive trichiasis surgery then will be followed at 1 day, 2 weeks, 6 weeks, and 12 months after surgery. Some participants may be asked to attend a follow-up visit at 3-6 months. The primary outcome is development of post-operative trachomatous trichiasis (PTT) within 12 months after surgery. Logistic regression analyses will be performed to compare the rates of PTT in the 3 versus 5 mm incision bilamellar tarsal rotation (BLTR) groups, in the 3 mm BLTR versus Trabut group, and in the 5 mm BLTR versus Trabut group, adjusting for demographic characteristics and pre-operative trichiasis severity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilamellar 3 mm | Active Comparator | Bilamellar tarsal rotation trichiasis surgery involves a full-thickness incision through the upper eyelid. For this arm, the height of the incision will be assigned at 3 mm from the eyelid margin. |
|
| Bilamellar 5mm | Active Comparator | Bilamellar tarsal rotation trichiasis surgery involves a full-thickness incision through the upper eyelid. For this arm, the height of the incision will be assigned at 5 mm from the eyelid margin. |
|
| Trabut 3mm | Active Comparator | Trabut surgery involves a partial-thickness incision through the upper eyelid parallel to the eyelid margin. For this surgery, the height of the incision will be assigned at 3 mm from the eyelid margin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilamellar 3 mm | Procedure | Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 3 mm from the eyelid margin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Eyes With Presence of Post-Operative Trichiasis Within 12 Months | Presence of post-operative trichiasis is defined as 1+ trichiatic eyelashes or evidence of recent epilation. Any eyelashes touching the eye with the eye in primary gaze are considered to be trichiatic. Outcomes will be evaluated at 6 weeks and 12 months. The first date of post-operative trichiasis will be used as the outcome. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Eyes With Presence of Post-Operative Trichiasis at 6 Weeks | Presence of post-operative trichiasis is defined as 1+ trichiatic eyelashes or evidence of recent epilation. Any eyelashes touching the eye with the eye in primary gaze are considered to be trichiatic. | 6 Weeks |
| Severity of Post-Operative Trichiasis at 6 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily Gower, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orbis Ethiopia | Hosa’ina | Southerns Nations, Nationalities, and Peoples' Region | Ethiopia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39226693 | Derived | Gower EW, Sisay A, Bayissasse B, Seyum D, Weaver J, Munoz B, Keil AP, Bankoski A, Sullivan KM, Kana H, Admassu F, Tadesse D, Merbs SL. The impact of modified incision height and surgical procedure on trichiasis surgery outcomes: Results of the maximizing trichiasis surgery success (MTSS) randomized trial. PLoS Negl Trop Dis. 2024 Sep 3;18(9):e0012034. doi: 10.1371/journal.pntd.0012034. eCollection 2024 Sep. | |
| 37757880 | Derived | Diallo AO, Bayissasse B, Sisay A, Seyum D, Weaver J, Munoz B, Merbs SL, Gower EW. Effectiveness of Trachomatous Trichiasis Case-identification Approaches in Ethiopia. Epidemiology. 2023 Nov 1;34(6):909-920. doi: 10.1097/EDE.0000000000001656. Epub 2023 Sep 26. |
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Deidentified data will be shared with researchers on an as requested basis after the primary results paper has been published. Interested researchers can contact the principal investigator by email in order to request data and provide a data analysis plan.
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9 to 36 months following publication
Deidentified individual data that supports the results will be shared provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bilamellar 3 mm | Bilamellar tarsal rotation trichiasis surgery involves a full-thickness incision through the upper eyelid. For this arm, the height of the incision will be assigned at 3 mm from the eyelid margin. Bilamellar 3 mm: Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 3 mm from the eyelid margin |
| FG001 | Bilamellar 5mm | Bilamellar tarsal rotation trichiasis surgery involves a full-thickness incision through the upper eyelid. For this arm, the height of the incision will be assigned at 5 mm from the eyelid margin. Bilamellar 5 mm: Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 5 mm from the eyelid margin |
| FG002 | Trabut 3mm | Trabut surgery involves a partial-thickness incision through the upper eyelid parallel to the eyelid margin. For this surgery, the height of the incision will be assigned at 3 mm from the eyelid margin. Trabut 3 mm: Trichiasis surgery using Trabut procedure with incision 3 mm from the eyelid margin |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bilamellar 3 mm | Bilamellar tarsal rotation trichiasis surgery involves a full-thickness incision through the upper eyelid. For this arm, the height of the incision will be assigned at 3 mm from the eyelid margin. Bilamellar 3 mm: Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 3 mm from the eyelid margin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Eyes With Presence of Post-Operative Trichiasis Within 12 Months | Presence of post-operative trichiasis is defined as 1+ trichiatic eyelashes or evidence of recent epilation. Any eyelashes touching the eye with the eye in primary gaze are considered to be trichiatic. Outcomes will be evaluated at 6 weeks and 12 months. The first date of post-operative trichiasis will be used as the outcome. | Data reported for those participants who completed the Week 6 and/or Month 12 assessment. | Posted | Count of Units | eyes | 12 Months | eyes | eyes |
|
From the time of signing informed consent through 3 year follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bilamellar 3 mm | Bilamellar tarsal rotation trichiasis surgery involves a full-thickness incision through the upper eyelid. For this arm, the height of the incision will be assigned at 3 mm from the eyelid margin. Bilamellar 3 mm: Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 3 mm from the eyelid margin |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kidney Stones | Hepatobiliary disorders | Systematic Assessment | Hospitalization was required due to kidney stones |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Gower, PhD | University of North Carolina at Chapel Hill | 919-966-1420 | egower@unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 10, 2021 | Sep 26, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058457 | Trichiasis |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| Bilamellar 5 mm | Procedure | Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 5 mm from the eyelid margin |
|
|
| Trabut 3 mm | Procedure | Trichiasis surgery using Trabut procedure with incision 3 mm from the eyelid margin |
|
|
Severity of post-operative trichiasis will be graded as mild, moderate, or severe based on number of eyelashes touching globe and number of eyelashes epilated. Definitions for trichiasis severity are: Mild: 1-4 Eyelashes touching globe, no epilation OR 1-10 Eyelashes epilated, no eyelashes touching globe; Moderate: 5-9 Eyelashes touching globe, no epilation OR 1-4 Eyelashes touching globe and 1-10 eyelashes epilated; Severe: 5-9 Eyelashes touching globe and 1-10 eyelashes epilated OR 10+ Eyelashes touching globe, regardless of epilation status OR 11-20 Eyelashes epilated, regardless of eyelashes touching globe OR Entire eyelid epilated |
| 6 Weeks |
| Severity of Post-Operative Trichiasis at 12 Months | Severity of post-operative trichiasis will be graded as mild, moderate, or severe based on number of eyelashes touching globe and number of eyelashes epilated. Definitions for trichiasis severity are: Mild: 1-4 Eyelashes touching globe, no epilation OR 1-10 Eyelashes epilated, no eyelashes touching globe; Moderate: 5-9 Eyelashes touching globe, no epilation OR 1-4 Eyelashes touching globe and 1-10 eyelashes epilated; Severe: 5-9 Eyelashes touching globe and 1-10 eyelashes epilated OR 10+ Eyelashes touching globe, regardless of epilation status OR 11-20 Eyelashes epilated, regardless of eyelashes touching globe OR Entire eyelid epilated | 12 Months |
| Number of Eyes With Presence of Eyelid Contour Abnormalities at 6 Weeks | A field and photograph examiner will grade the presence of abnormality independently, using a standardized definition. For this analysis, mild will be combined with normal to create "no significant abnormality" and moderate and severe will be combined into a "moderate/severe contour abnormality" group. The photographic grade will serve as the primary grade for this measure. Definitions for abnormality are: Mild: Vertical deviation from the natural contour, 1 mm in height (less than half the pupil height in daylight) and affecting 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour 2 mm in height (more than the pupil height in daylight) or a defect >2/3 of the horizontal eyelid length | 6 Weeks |
| Number of Eyes With Presence of Eyelid Contour Abnormalities Within 12 Months | A field and photograph examiner will grade the presence of abnormality independently. For this analysis, mild is combined with normal to create "no significant abnormality" and moderate and severe are combined into a "moderate/severe contour abnormality" group. The photographic grade will serve as the primary grade. The 12 month dichotomous photograph grade will be the main eyelid contour abnormality (ECA) outcome. Data from the last completed visit (6 weeks or 12 months) are used. Definitions for abnormality are: Mild: Vertical deviation from the natural contour, 1 mm in height (less than half the pupil height in daylight) and affecting 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour 2 mm in height (more than the pupil height in daylight) or a defect >2/3 of the horizontal eyelid length | 12 Months |
| Severity of Eyelid Contour Abnormalities at 6 Weeks | Using the grades obtained in the outcome above, the eyelid contour abnormality will be reported as none, mild, moderate, or severe. This is a secondary outcome and will only utilize the photograph grade for this outcome. Definitions for abnormality are: Mild: Vertical deviation from the natural contour, 1 mm in height (less than half the pupil height in daylight) and affecting 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour 2 mm in height (more than the pupil height in daylight) or a defect >2/3 of the horizontal eyelid length | 6 Weeks |
| Severity of Eyelid Contour Abnormalities at 12 Months | The eyelid contour abnormality will be reported as none, mild, moderate, or severe. This is a secondary outcome and will only utilize the photograph grade for this outcome. Definitions for abnormality are: Mild: Vertical deviation from the natural contour, 1 mm in height (less than half the pupil height in daylight) and affecting 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour 2 mm in height (more than the pupil height in daylight) or a defect >2/3 of the horizontal eyelid length. | 12 Months |
| Number of Eyes With Changes in Eyelid Contour Abnormalities Between 6 Weeks and 1 Year | The severity of eyelid contour abnormality can lessen over time. The severity will be compared at 6 weeks and 12 months. | 12 months |
| Number of Eyes With Presence of Pyogenic Granuloma at 6 Weeks | Pyogenic granulomas occasionally develop after trichiasis surgery, and it is thought that these are a response to a foreign body, such as suture material or a jagged incision edge. The patient examiners will evaluate presence of granulomas, and all granulomas will be noted, regardless of size. | 6 weeks |
| Number of Eyes With Presence of Pyogenic Granulomas Within 12 Months | Pyogenic granulomas occasionally develop after trichiasis surgery, and it is thought that these are a response to a foreign body, such as suture material or a jagged incision edge. The patient examiners will evaluate presence of granulomas, and all granulomas will be noted, regardless of size. Data are included for both 6 weeks and 12 months. | up to 12 Months |
| Number of Eyes With Presence of Post-Operative Trichiasis Within 3 Years | Presence of post-operative trichiasis is defined as 1+ trichiatic eyelashes or evidence of recent epilation. Any eyelashes touching the eye with the eye in primary gaze are considered to be trichiatic. Outcomes will be evaluated based on visits at 6 weeks, 12 months and/or Year 3. | up to 3 Years |
| 32193277 | Derived | Bayissasse B, Sullivan KM, Merbs SL, Munoz B, Keil A, Sisay A, Singer A, Gower EW. Maximising trichiasis surgery success (MTSS) trial: rationale and design of a randomised controlled trial to improve trachomatous trichiasis surgical outcomes. BMJ Open. 2020 Mar 18;10(3):e036327. doi: 10.1136/bmjopen-2019-036327. |
| BG001 |
| Bilamellar 5mm |
Bilamellar tarsal rotation trichiasis surgery involves a full-thickness incision through the upper eyelid. For this arm, the height of the incision will be assigned at 5 mm from the eyelid margin. Bilamellar 5 mm: Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 5 mm from the eyelid margin |
| BG002 | Trabut 3mm | Trabut surgery involves a partial-thickness incision through the upper eyelid parallel to the eyelid margin. For this surgery, the height of the incision will be assigned at 3 mm from the eyelid margin. Trabut 3 mm: Trichiasis surgery using Trabut procedure with incision 3 mm from the eyelid margin |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Bilamellar 5mm | Bilamellar tarsal rotation trichiasis surgery involves a full-thickness incision through the upper eyelid. For this arm, the height of the incision will be assigned at 5 mm from the eyelid margin. Bilamellar 5 mm: Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 5 mm from the eyelid margin |
| OG002 | Trabut 3mm | Trabut surgery involves a partial-thickness incision through the upper eyelid parallel to the eyelid margin. For this surgery, the height of the incision will be assigned at 3 mm from the eyelid margin. Trabut 3 mm: Trichiasis surgery using Trabut procedure with incision 3 mm from the eyelid margin |
|
|
|
| Secondary | Number of Eyes With Presence of Post-Operative Trichiasis at 6 Weeks | Presence of post-operative trichiasis is defined as 1+ trichiatic eyelashes or evidence of recent epilation. Any eyelashes touching the eye with the eye in primary gaze are considered to be trichiatic. | Data reported only for those participants who completed the Week 6 assessment. | Posted | Count of Units | Eyes | 6 Weeks | Eyes | Eyes |
|
|
|
| Secondary | Severity of Post-Operative Trichiasis at 6 Weeks | Severity of post-operative trichiasis will be graded as mild, moderate, or severe based on number of eyelashes touching globe and number of eyelashes epilated. Definitions for trichiasis severity are: Mild: 1-4 Eyelashes touching globe, no epilation OR 1-10 Eyelashes epilated, no eyelashes touching globe; Moderate: 5-9 Eyelashes touching globe, no epilation OR 1-4 Eyelashes touching globe and 1-10 eyelashes epilated; Severe: 5-9 Eyelashes touching globe and 1-10 eyelashes epilated OR 10+ Eyelashes touching globe, regardless of epilation status OR 11-20 Eyelashes epilated, regardless of eyelashes touching globe OR Entire eyelid epilated | Data reported only for those participants who completed the Week 6 assessment. | Posted | Count of Units | Eyes | 6 Weeks | Eyes | Eyes |
|
|
|
| Secondary | Severity of Post-Operative Trichiasis at 12 Months | Severity of post-operative trichiasis will be graded as mild, moderate, or severe based on number of eyelashes touching globe and number of eyelashes epilated. Definitions for trichiasis severity are: Mild: 1-4 Eyelashes touching globe, no epilation OR 1-10 Eyelashes epilated, no eyelashes touching globe; Moderate: 5-9 Eyelashes touching globe, no epilation OR 1-4 Eyelashes touching globe and 1-10 eyelashes epilated; Severe: 5-9 Eyelashes touching globe and 1-10 eyelashes epilated OR 10+ Eyelashes touching globe, regardless of epilation status OR 11-20 Eyelashes epilated, regardless of eyelashes touching globe OR Entire eyelid epilated | Data reported only for those participants who completed the Month 12 assessment. | Posted | Count of Units | Eyes | 12 Months | Eyes | Eyes |
|
|
|
| Secondary | Number of Eyes With Presence of Eyelid Contour Abnormalities at 6 Weeks | A field and photograph examiner will grade the presence of abnormality independently, using a standardized definition. For this analysis, mild will be combined with normal to create "no significant abnormality" and moderate and severe will be combined into a "moderate/severe contour abnormality" group. The photographic grade will serve as the primary grade for this measure. Definitions for abnormality are: Mild: Vertical deviation from the natural contour, 1 mm in height (less than half the pupil height in daylight) and affecting 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour 2 mm in height (more than the pupil height in daylight) or a defect >2/3 of the horizontal eyelid length | Data reported only for those participants who completed the Week 6 assessment. | Posted | Count of Units | Eyes | 6 Weeks | Eyes | Eyes |
|
|
|
| Secondary | Number of Eyes With Presence of Eyelid Contour Abnormalities Within 12 Months | A field and photograph examiner will grade the presence of abnormality independently. For this analysis, mild is combined with normal to create "no significant abnormality" and moderate and severe are combined into a "moderate/severe contour abnormality" group. The photographic grade will serve as the primary grade. The 12 month dichotomous photograph grade will be the main eyelid contour abnormality (ECA) outcome. Data from the last completed visit (6 weeks or 12 months) are used. Definitions for abnormality are: Mild: Vertical deviation from the natural contour, 1 mm in height (less than half the pupil height in daylight) and affecting 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour 2 mm in height (more than the pupil height in daylight) or a defect >2/3 of the horizontal eyelid length | Posted | Count of Units | eyes | 12 Months | eyes | eyes |
|
|
|
|
| Secondary | Severity of Eyelid Contour Abnormalities at 6 Weeks | Using the grades obtained in the outcome above, the eyelid contour abnormality will be reported as none, mild, moderate, or severe. This is a secondary outcome and will only utilize the photograph grade for this outcome. Definitions for abnormality are: Mild: Vertical deviation from the natural contour, 1 mm in height (less than half the pupil height in daylight) and affecting 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour 2 mm in height (more than the pupil height in daylight) or a defect >2/3 of the horizontal eyelid length | Data reported only for those participants who completed the Week 6 assessment. | Posted | Count of Units | Eyes | 6 Weeks | Eyes | Eyes |
|
|
|
| Secondary | Severity of Eyelid Contour Abnormalities at 12 Months | The eyelid contour abnormality will be reported as none, mild, moderate, or severe. This is a secondary outcome and will only utilize the photograph grade for this outcome. Definitions for abnormality are: Mild: Vertical deviation from the natural contour, 1 mm in height (less than half the pupil height in daylight) and affecting 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour 2 mm in height (more than the pupil height in daylight) or a defect >2/3 of the horizontal eyelid length. | Data reported only for those participants who completed the Month 12 assessment. | Posted | Count of Units | Eyes | 12 Months | Eyes | Eyes |
|
|
|
| Secondary | Number of Eyes With Changes in Eyelid Contour Abnormalities Between 6 Weeks and 1 Year | The severity of eyelid contour abnormality can lessen over time. The severity will be compared at 6 weeks and 12 months. | Only includes participants seen at both 6 weeks and 12 months. | Posted | Count of Units | Eyes | 12 months | Eyes | Eyes |
|
|
|
| Secondary | Number of Eyes With Presence of Pyogenic Granuloma at 6 Weeks | Pyogenic granulomas occasionally develop after trichiasis surgery, and it is thought that these are a response to a foreign body, such as suture material or a jagged incision edge. The patient examiners will evaluate presence of granulomas, and all granulomas will be noted, regardless of size. | Data reported only for those participants who completed the Week 6 assessment. | Posted | Count of Units | Eyes | 6 weeks | Eyes | Eyes |
|
|
|
| Secondary | Number of Eyes With Presence of Pyogenic Granulomas Within 12 Months | Pyogenic granulomas occasionally develop after trichiasis surgery, and it is thought that these are a response to a foreign body, such as suture material or a jagged incision edge. The patient examiners will evaluate presence of granulomas, and all granulomas will be noted, regardless of size. Data are included for both 6 weeks and 12 months. | Posted | Count of Units | Eyes | up to 12 Months | Eyes | Eyes |
|
|
|
|
| Secondary | Number of Eyes With Presence of Post-Operative Trichiasis Within 3 Years | Presence of post-operative trichiasis is defined as 1+ trichiatic eyelashes or evidence of recent epilation. Any eyelashes touching the eye with the eye in primary gaze are considered to be trichiatic. Outcomes will be evaluated based on visits at 6 weeks, 12 months and/or Year 3. | Data reported for those participants who completed the Week 6, Month 12 and/or Year 3 assessment. | Posted | Count of Units | Eyes | up to 3 Years | Eyes | Eyes |
|
|
|
| 113 |
| 1,631 |
| 0 |
| 1,631 |
| 0 |
| 1,631 |
| EG001 | Bilamellar 5mm | Bilamellar tarsal rotation trichiasis surgery involves a full-thickness incision through the upper eyelid. For this arm, the height of the incision will be assigned at 5 mm from the eyelid margin. Bilamellar 5 mm: Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 5 mm from the eyelid margin | 103 | 1,648 | 1 | 1,648 | 0 | 1,648 |
| EG002 | Trabut 3mm | Trabut surgery involves a partial-thickness incision through the upper eyelid parallel to the eyelid margin. For this surgery, the height of the incision will be assigned at 3 mm from the eyelid margin. Trabut 3 mm: Trichiasis surgery using Trabut procedure with incision 3 mm from the eyelid margin | 102 | 1,635 | 1 | 1,635 | 0 | 1,635 |
|
| Whole Body Edema | Vascular disorders | Systematic Assessment | Whole body edema requiring hospitalization |
|
Not provided
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
|
|
| <0.0001 |
p-value adjusted for multiple comparisons, the a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167. |
| Odds Ratio (OR) |
| 0.50 |
| 2-Sided |
| 98.3 |
| 0.38 |
| 0.67 |
| Superiority |
| Regression, Logistic | <0.0001 | The a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167. | Odds Ratio (OR) | 0.60 | 2-Sided | 98.3 | 0.45 | 0.80 | Superiority |
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Worse |
|
| Odds Ratio (OR) |
| 0.68 |
| 2-Sided |
| 98.3 |
| 0.49 |
| 0.93 |
| Superiority |
| Regression, Logistic | 0.08 | Odds Ratio (OR) | 0.78 | 2-Sided | 98.3 | 0.57 | 1.09 | Superiority |