Surgery, Trichiasis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREBilamellar 3 mm
Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 3 mm from the eyelid margin
PROCEDUREBilamellar 5 mm
Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 5 mm from the eyelid margin
PROCEDURETrabut 3 mm
Trichiasis surgery using Trabut procedure with incision 3 mm from the eyelid margin
Sponsors
Orbis
National Eye Institute (NEI)
University of Maryland, Baltimore
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least one eyelid with previously unoperated upper eyelid trichiasis * Willing to comply with all study procedures and be available for the duration of the study
Exclusion criteria
* Inability to provide independent, informed consent * All eyes with previously unoperated trichiasis are phthisical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Eyes With Presence of Post-Operative Trichiasis Within 12 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Post-Operative Trichiasis at 6 Weeks | 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 |
| Severity of Post-Operative Trichiasis at 12 Months | 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 |
| Number of Eyes With Presence of Eyelid Contour Abnormalities at 6 Weeks | 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 |
| Number of Eyes With Presence of Eyelid Contour Abnormalities Within 12 Months | 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 |
| Severity of Eyelid Contour Abnormalities at 6 Weeks | 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 |
| Number of Eyes With Presence of Post-Operative Trichiasis at 6 Weeks | 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. |
| Number of Eyes With Changes in Eyelid Contour Abnormalities Between 6 Weeks and 1 Year | 12 months | The severity of eyelid contour abnormality can lessen over time. The severity will be compared at 6 weeks and 12 months. |
| Number of Eyes With Presence of Pyogenic Granuloma at 6 Weeks | 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. |
| Number of Eyes With Presence of Pyogenic Granulomas Within 12 Months | up to 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. |
| Number of Eyes With Presence of Post-Operative Trichiasis Within 3 Years | up to 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. |
| Severity of Eyelid Contour Abnormalities at 12 Months | 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. |
Countries
Ethiopia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 1,631 |
| 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 | 1,648 |
| 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 | 1,635 |
| Total | 4,914 |
Baseline characteristics
| Characteristic | Bilamellar 3 mm | Bilamellar 5mm | Trabut 3mm | Total |
|---|---|---|---|---|
| Age, Customized 40-60 years | 1075 Participants | 1041 Participants | 1053 Participants | 3169 Participants |
| Age, Customized < 40 years | 291 Participants | 314 Participants | 311 Participants | 916 Participants |
| Age, Customized > 60 years | 265 Participants | 293 Participants | 271 Participants | 829 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1631 Participants | 1648 Participants | 1635 Participants | 4914 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1631 Participants | 1648 Participants | 1635 Participants | 4914 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Ethiopia | 1631 Participants | 1648 Participants | 1635 Participants | 4914 Participants |
| Sex: Female, Male Female | 1222 Participants | 1261 Participants | 1223 Participants | 3706 Participants |
| Sex: Female, Male Male | 409 Participants | 387 Participants | 412 Participants | 1208 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 113 / 1,631 | 103 / 1,648 | 102 / 1,635 |
| other Total, other adverse events | 0 / 1,631 | 0 / 1,648 | 0 / 1,635 |
| serious Total, serious adverse events | 0 / 1,631 | 1 / 1,648 | 1 / 1,635 |
Outcome results
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.
Time frame: 12 Months
Population: Data reported for those participants who completed the Week 6 and/or Month 12 assessment.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Bilamellar 3 mm | Number of Eyes With Presence of Post-Operative Trichiasis Within 12 Months | 347 eyes |
| Bilamellar 5mm | Number of Eyes With Presence of Post-Operative Trichiasis Within 12 Months | 504 eyes |
| Trabut 3mm | Number of Eyes With Presence of Post-Operative Trichiasis Within 12 Months | 298 eyes |
p-value: 0.03998.3% CI: [0.97, 1.52]Regression, Logistic
p-value: <0.000198.3% CI: [1.54, 2.36]Regression, Logistic
p-value: <0.000198.3% CI: [1.29, 1.92]Regression, Logistic
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.
Time frame: 12 months
Population: Only includes participants seen at both 6 weeks and 12 months.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Bilamellar 3 mm | Number of Eyes With Changes in Eyelid Contour Abnormalities Between 6 Weeks and 1 Year | Same | 1721 Eyes |
| Bilamellar 3 mm | Number of Eyes With Changes in Eyelid Contour Abnormalities Between 6 Weeks and 1 Year | Better | 183 Eyes |
| Bilamellar 3 mm | Number of Eyes With Changes in Eyelid Contour Abnormalities Between 6 Weeks and 1 Year | Worse | 16 Eyes |
| Bilamellar 5mm | Number of Eyes With Changes in Eyelid Contour Abnormalities Between 6 Weeks and 1 Year | Same | 1769 Eyes |
| Bilamellar 5mm | Number of Eyes With Changes in Eyelid Contour Abnormalities Between 6 Weeks and 1 Year | Better | 159 Eyes |
| Bilamellar 5mm | Number of Eyes With Changes in Eyelid Contour Abnormalities Between 6 Weeks and 1 Year | Worse | 11 Eyes |
| Trabut 3mm | Number of Eyes With Changes in Eyelid Contour Abnormalities Between 6 Weeks and 1 Year | Better | 208 Eyes |
| Trabut 3mm | Number of Eyes With Changes in Eyelid Contour Abnormalities Between 6 Weeks and 1 Year | Worse | 17 Eyes |
| Trabut 3mm | Number of Eyes With Changes in Eyelid Contour Abnormalities Between 6 Weeks and 1 Year | Same | 1731 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
Time frame: 6 Weeks
Population: Data reported only for those participants who completed the Week 6 assessment.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Bilamellar 3 mm | Number of Eyes With Presence of Eyelid Contour Abnormalities at 6 Weeks | no significant abnormality | 1748 Eyes |
| Bilamellar 3 mm | Number of Eyes With Presence of Eyelid Contour Abnormalities at 6 Weeks | Moderate/severe contour abnormality | 384 Eyes |
| Bilamellar 5mm | Number of Eyes With Presence of Eyelid Contour Abnormalities at 6 Weeks | no significant abnormality | 1845 Eyes |
| Bilamellar 5mm | Number of Eyes With Presence of Eyelid Contour Abnormalities at 6 Weeks | Moderate/severe contour abnormality | 291 Eyes |
| Trabut 3mm | Number of Eyes With Presence of Eyelid Contour Abnormalities at 6 Weeks | no significant abnormality | 1716 Eyes |
| Trabut 3mm | Number of Eyes With Presence of Eyelid Contour Abnormalities at 6 Weeks | Moderate/severe contour abnormality | 432 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
Time frame: 12 Months
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Bilamellar 3 mm | Number of Eyes With Presence of Eyelid Contour Abnormalities Within 12 Months | no significant abnormality | 2040 eyes |
| Bilamellar 3 mm | Number of Eyes With Presence of Eyelid Contour Abnormalities Within 12 Months | moderate/severe contour abnormality | 217 eyes |
| Bilamellar 5mm | Number of Eyes With Presence of Eyelid Contour Abnormalities Within 12 Months | no significant abnormality | 2151 eyes |
| Bilamellar 5mm | Number of Eyes With Presence of Eyelid Contour Abnormalities Within 12 Months | moderate/severe contour abnormality | 139 eyes |
| Trabut 3mm | Number of Eyes With Presence of Eyelid Contour Abnormalities Within 12 Months | no significant abnormality | 2015 eyes |
| Trabut 3mm | Number of Eyes With Presence of Eyelid Contour Abnormalities Within 12 Months | moderate/severe contour abnormality | 253 eyes |
p-value: 0.09498.3% CI: [0.65, 1.08]Regression, Logistic
p-value: <0.000198.3% CI: [0.38, 0.67]Regression, Logistic
p-value: <0.000198.3% CI: [0.45, 0.8]Regression, Logistic
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.
Time frame: 6 Weeks
Population: Data reported only for those participants who completed the Week 6 assessment.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Bilamellar 3 mm | Number of Eyes With Presence of Post-Operative Trichiasis at 6 Weeks | 47 Eyes |
| Bilamellar 5mm | Number of Eyes With Presence of Post-Operative Trichiasis at 6 Weeks | 101 Eyes |
| Trabut 3mm | Number of Eyes With Presence of Post-Operative Trichiasis at 6 Weeks | 59 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.
Time frame: up to 3 Years
Population: Data reported for those participants who completed the Week 6, Month 12 and/or Year 3 assessment.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Bilamellar 3 mm | Number of Eyes With Presence of Post-Operative Trichiasis Within 3 Years | 451 Eyes |
| Bilamellar 5mm | Number of Eyes With Presence of Post-Operative Trichiasis Within 3 Years | 663 Eyes |
| Trabut 3mm | Number of Eyes With Presence of Post-Operative Trichiasis Within 3 Years | 401 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.
Time frame: 6 weeks
Population: Data reported only for those participants who completed the Week 6 assessment.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Bilamellar 3 mm | Number of Eyes With Presence of Pyogenic Granuloma at 6 Weeks | 142 Eyes |
| Bilamellar 5mm | Number of Eyes With Presence of Pyogenic Granuloma at 6 Weeks | 109 Eyes |
| Trabut 3mm | Number of Eyes With Presence of Pyogenic Granuloma at 6 Weeks | 166 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.
Time frame: up to 12 Months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Bilamellar 3 mm | Number of Eyes With Presence of Pyogenic Granulomas Within 12 Months | 147 Eyes |
| Bilamellar 5mm | Number of Eyes With Presence of Pyogenic Granulomas Within 12 Months | 118 Eyes |
| Trabut 3mm | Number of Eyes With Presence of Pyogenic Granulomas Within 12 Months | 170 Eyes |
p-value: 0.2498.3% CI: [0.64, 1.17]Regression, Logistic
p-value: 0.003798.3% CI: [0.49, 0.93]Regression, Logistic
p-value: 0.0898.3% CI: [0.57, 1.09]Regression, Logistic
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.
Time frame: 12 Months
Population: Data reported only for those participants who completed the Month 12 assessment.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Bilamellar 3 mm | Severity of Eyelid Contour Abnormalities at 12 Months | None | 1780 Eyes |
| Bilamellar 3 mm | Severity of Eyelid Contour Abnormalities at 12 Months | Mild | 90 Eyes |
| Bilamellar 3 mm | Severity of Eyelid Contour Abnormalities at 12 Months | Moderate | 132 Eyes |
| Bilamellar 3 mm | Severity of Eyelid Contour Abnormalities at 12 Months | Severe | 50 Eyes |
| Bilamellar 5mm | Severity of Eyelid Contour Abnormalities at 12 Months | Severe | 33 Eyes |
| Bilamellar 5mm | Severity of Eyelid Contour Abnormalities at 12 Months | None | 1909 Eyes |
| Bilamellar 5mm | Severity of Eyelid Contour Abnormalities at 12 Months | Moderate | 79 Eyes |
| Bilamellar 5mm | Severity of Eyelid Contour Abnormalities at 12 Months | Mild | 76 Eyes |
| Trabut 3mm | Severity of Eyelid Contour Abnormalities at 12 Months | Severe | 23 Eyes |
| Trabut 3mm | Severity of Eyelid Contour Abnormalities at 12 Months | Mild | 194 Eyes |
| Trabut 3mm | Severity of Eyelid Contour Abnormalities at 12 Months | Moderate | 186 Eyes |
| Trabut 3mm | Severity of Eyelid Contour Abnormalities at 12 Months | None | 1678 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
Time frame: 6 Weeks
Population: Data reported only for those participants who completed the Week 6 assessment.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Bilamellar 3 mm | Severity of Eyelid Contour Abnormalities at 6 Weeks | None | 1465 Eyes |
| Bilamellar 3 mm | Severity of Eyelid Contour Abnormalities at 6 Weeks | Mild | 283 Eyes |
| Bilamellar 3 mm | Severity of Eyelid Contour Abnormalities at 6 Weeks | Moderate | 197 Eyes |
| Bilamellar 3 mm | Severity of Eyelid Contour Abnormalities at 6 Weeks | Severe | 187 Eyes |
| Bilamellar 5mm | Severity of Eyelid Contour Abnormalities at 6 Weeks | Severe | 164 Eyes |
| Bilamellar 5mm | Severity of Eyelid Contour Abnormalities at 6 Weeks | None | 1652 Eyes |
| Bilamellar 5mm | Severity of Eyelid Contour Abnormalities at 6 Weeks | Moderate | 127 Eyes |
| Bilamellar 5mm | Severity of Eyelid Contour Abnormalities at 6 Weeks | Mild | 193 Eyes |
| Trabut 3mm | Severity of Eyelid Contour Abnormalities at 6 Weeks | Severe | 110 Eyes |
| Trabut 3mm | Severity of Eyelid Contour Abnormalities at 6 Weeks | Mild | 354 Eyes |
| Trabut 3mm | Severity of Eyelid Contour Abnormalities at 6 Weeks | Moderate | 323 Eyes |
| Trabut 3mm | Severity of Eyelid Contour Abnormalities at 6 Weeks | None | 1361 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
Time frame: 12 Months
Population: Data reported only for those participants who completed the Month 12 assessment.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Bilamellar 3 mm | Severity of Post-Operative Trichiasis at 12 Months | Moderate | 34 Eyes |
| Bilamellar 3 mm | Severity of Post-Operative Trichiasis at 12 Months | None | 1714 Eyes |
| Bilamellar 3 mm | Severity of Post-Operative Trichiasis at 12 Months | Mild | 267 Eyes |
| Bilamellar 3 mm | Severity of Post-Operative Trichiasis at 12 Months | Severe | 37 Eyes |
| Bilamellar 5mm | Severity of Post-Operative Trichiasis at 12 Months | None | 1620 Eyes |
| Bilamellar 5mm | Severity of Post-Operative Trichiasis at 12 Months | Moderate | 68 Eyes |
| Bilamellar 5mm | Severity of Post-Operative Trichiasis at 12 Months | Severe | 61 Eyes |
| Bilamellar 5mm | Severity of Post-Operative Trichiasis at 12 Months | Mild | 348 Eyes |
| Trabut 3mm | Severity of Post-Operative Trichiasis at 12 Months | Severe | 34 Eyes |
| Trabut 3mm | Severity of Post-Operative Trichiasis at 12 Months | Moderate | 44 Eyes |
| Trabut 3mm | Severity of Post-Operative Trichiasis at 12 Months | Mild | 202 Eyes |
| Trabut 3mm | Severity of Post-Operative Trichiasis at 12 Months | None | 1801 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
Time frame: 6 Weeks
Population: Data reported only for those participants who completed the Week 6 assessment.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Bilamellar 3 mm | Severity of Post-Operative Trichiasis at 6 Weeks | None | 2085 Eyes |
| Bilamellar 3 mm | Severity of Post-Operative Trichiasis at 6 Weeks | Mild | 35 Eyes |
| Bilamellar 3 mm | Severity of Post-Operative Trichiasis at 6 Weeks | Moderate | 8 Eyes |
| Bilamellar 3 mm | Severity of Post-Operative Trichiasis at 6 Weeks | Severe | 4 Eyes |
| Bilamellar 5mm | Severity of Post-Operative Trichiasis at 6 Weeks | Severe | 10 Eyes |
| Bilamellar 5mm | Severity of Post-Operative Trichiasis at 6 Weeks | None | 2035 Eyes |
| Bilamellar 5mm | Severity of Post-Operative Trichiasis at 6 Weeks | Moderate | 12 Eyes |
| Bilamellar 5mm | Severity of Post-Operative Trichiasis at 6 Weeks | Mild | 79 Eyes |
| Trabut 3mm | Severity of Post-Operative Trichiasis at 6 Weeks | Severe | 6 Eyes |
| Trabut 3mm | Severity of Post-Operative Trichiasis at 6 Weeks | Mild | 42 Eyes |
| Trabut 3mm | Severity of Post-Operative Trichiasis at 6 Weeks | Moderate | 11 Eyes |
| Trabut 3mm | Severity of Post-Operative Trichiasis at 6 Weeks | None | 2089 Eyes |