Trial Outcomes & Findings for Maximizing Trichiasis Surgery Success (NCT NCT03100747)

NCT ID: NCT03100747

Last Updated: 2023-12-05

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 4914 participants
• Primary outcome timeframe: 12 Months
• Results posted on: 2023-12-05

Participant Flow

Unit of analysis: eyes

Participant milestones

Measure	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	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	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
Overall Study STARTED	1631 2299	1648 2337	1635 2304
Overall Study Completed Week 6	1514 2132	1498 2136	1518 2148
Overall Study Completed Month 12	1467 2052	1478 2097	1468 2081
Overall Study Completed Week 6 and/or Month 12	1600 2257	1609 2290	1610 2268
Overall Study Completed Year 3	1253 1760	1238 1757	1261 1781
Overall Study COMPLETED	1253 1760	1238 1757	1261 1781
Overall Study NOT COMPLETED	378 539	410 580	374 523

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Maximizing Trichiasis Surgery Success

Baseline characteristics by cohort

Measure	Bilamellar 3 mm n=1631 Participants 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	Bilamellar 5mm n=1648 Participants 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	Trabut 3mm n=1635 Participants 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	Total n=4914 Participants Total of all reporting groups
Age, Customized < 40 years	291 Participants n=5 Participants	314 Participants n=7 Participants	311 Participants n=5 Participants	916 Participants n=4 Participants
Age, Customized 40-60 years	1075 Participants n=5 Participants	1041 Participants n=7 Participants	1053 Participants n=5 Participants	3169 Participants n=4 Participants
Age, Customized > 60 years	265 Participants n=5 Participants	293 Participants n=7 Participants	271 Participants n=5 Participants	829 Participants n=4 Participants
Sex: Female, Male Female	1222 Participants n=5 Participants	1261 Participants n=7 Participants	1223 Participants n=5 Participants	3706 Participants n=4 Participants
Sex: Female, Male Male	409 Participants n=5 Participants	387 Participants n=7 Participants	412 Participants n=5 Participants	1208 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1631 Participants n=5 Participants	1648 Participants n=7 Participants	1635 Participants n=5 Participants	4914 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1631 Participants n=5 Participants	1648 Participants n=7 Participants	1635 Participants n=5 Participants	4914 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Ethiopia	1631 Participants n=5 Participants	1648 Participants n=7 Participants	1635 Participants n=5 Participants	4914 Participants n=4 Participants

PRIMARY outcome

Timeframe: 12 Months

Population: Data reported for those participants who completed the Week 6 and/or Month 12 assessment.

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.

Outcome measures

Measure	Bilamellar 3 mm n=2257 eyes 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	Bilamellar 5mm n=2290 eyes 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	Trabut 3mm n=2268 eyes 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
Number of Eyes With Presence of Post-Operative Trichiasis Within 12 Months	347 eyes	504 eyes	298 eyes

SECONDARY outcome

Timeframe: 6 Weeks

Population: Data reported only for those participants who completed the Week 6 assessment.

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.

Outcome measures

Measure	Bilamellar 3 mm n=2132 Eyes 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	Bilamellar 5mm n=2136 Eyes 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	Trabut 3mm n=2148 Eyes 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
Number of Eyes With Presence of Post-Operative Trichiasis at 6 Weeks	47 Eyes	101 Eyes	59 Eyes

SECONDARY outcome

Timeframe: 6 Weeks

Population: Data reported only for those participants who completed the Week 6 assessment.

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

Outcome measures

Measure	Bilamellar 3 mm n=2132 Eyes 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	Bilamellar 5mm n=2136 Eyes 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	Trabut 3mm n=2148 Eyes 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
Severity of Post-Operative Trichiasis at 6 Weeks None	2085 Eyes	2035 Eyes	2089 Eyes
Severity of Post-Operative Trichiasis at 6 Weeks Mild	35 Eyes	79 Eyes	42 Eyes
Severity of Post-Operative Trichiasis at 6 Weeks Moderate	8 Eyes	12 Eyes	11 Eyes
Severity of Post-Operative Trichiasis at 6 Weeks Severe	4 Eyes	10 Eyes	6 Eyes

SECONDARY outcome

Timeframe: 12 Months

Population: Data reported only for those participants who completed the Month 12 assessment.

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

Outcome measures

Measure	Bilamellar 3 mm n=2052 Eyes 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	Bilamellar 5mm n=2097 Eyes 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	Trabut 3mm n=2081 Eyes 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
Severity of Post-Operative Trichiasis at 12 Months Mild	267 Eyes	348 Eyes	202 Eyes
Severity of Post-Operative Trichiasis at 12 Months None	1714 Eyes	1620 Eyes	1801 Eyes
Severity of Post-Operative Trichiasis at 12 Months Moderate	34 Eyes	68 Eyes	44 Eyes
Severity of Post-Operative Trichiasis at 12 Months Severe	37 Eyes	61 Eyes	34 Eyes

SECONDARY outcome

Timeframe: 6 Weeks

Population: Data reported only for those participants who completed the Week 6 assessment.

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

Outcome measures

Measure	Bilamellar 3 mm n=1514 Participants 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	Bilamellar 5mm n=2136 Eyes 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	Trabut 3mm n=2148 Eyes 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
Number of Eyes With Presence of Eyelid Contour Abnormalities at 6 Weeks no significant abnormality	1748 Eyes	1845 Eyes	1716 Eyes
Number of Eyes With Presence of Eyelid Contour Abnormalities at 6 Weeks Moderate/severe contour abnormality	384 Eyes	291 Eyes	432 Eyes

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Bilamellar 3 mm n=2257 eyes 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	Bilamellar 5mm n=2290 eyes 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	Trabut 3mm n=2268 eyes 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
Number of Eyes With Presence of Eyelid Contour Abnormalities Within 12 Months no significant abnormality	2040 eyes	2151 eyes	2015 eyes
Number of Eyes With Presence of Eyelid Contour Abnormalities Within 12 Months moderate/severe contour abnormality	217 eyes	139 eyes	253 eyes

SECONDARY outcome

Timeframe: 6 Weeks

Population: Data reported only for those participants who completed the Week 6 assessment.

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

Outcome measures

Measure	Bilamellar 3 mm n=2132 Eyes 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	Bilamellar 5mm n=2136 Eyes 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	Trabut 3mm n=2148 Eyes 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
Severity of Eyelid Contour Abnormalities at 6 Weeks None	1465 Eyes	1652 Eyes	1361 Eyes
Severity of Eyelid Contour Abnormalities at 6 Weeks Mild	283 Eyes	193 Eyes	354 Eyes
Severity of Eyelid Contour Abnormalities at 6 Weeks Moderate	197 Eyes	127 Eyes	323 Eyes
Severity of Eyelid Contour Abnormalities at 6 Weeks Severe	187 Eyes	164 Eyes	110 Eyes

SECONDARY outcome

Timeframe: 12 Months

Population: Data reported only for those participants who completed the Month 12 assessment.

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.

Outcome measures

Measure	Bilamellar 3 mm n=2052 Eyes 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	Bilamellar 5mm n=2097 Eyes 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	Trabut 3mm n=2081 Eyes 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
Severity of Eyelid Contour Abnormalities at 12 Months None	1780 Eyes	1909 Eyes	1678 Eyes
Severity of Eyelid Contour Abnormalities at 12 Months Mild	90 Eyes	76 Eyes	194 Eyes
Severity of Eyelid Contour Abnormalities at 12 Months Moderate	132 Eyes	79 Eyes	186 Eyes
Severity of Eyelid Contour Abnormalities at 12 Months Severe	50 Eyes	33 Eyes	23 Eyes

SECONDARY outcome

Timeframe: 12 months

Population: Only includes participants seen at both 6 weeks and 12 months.

The severity of eyelid contour abnormality can lessen over time. The severity will be compared at 6 weeks and 12 months.

Outcome measures

Measure	Bilamellar 3 mm n=1920 Eyes 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	Bilamellar 5mm n=1939 Eyes 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	Trabut 3mm n=1956 Eyes 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
Number of Eyes With Changes in Eyelid Contour Abnormalities Between 6 Weeks and 1 Year Better	183 Eyes	159 Eyes	208 Eyes
Number of Eyes With Changes in Eyelid Contour Abnormalities Between 6 Weeks and 1 Year Same	1721 Eyes	1769 Eyes	1731 Eyes
Number of Eyes With Changes in Eyelid Contour Abnormalities Between 6 Weeks and 1 Year Worse	16 Eyes	11 Eyes	17 Eyes

SECONDARY outcome

Timeframe: 6 weeks

Population: Data reported only for those participants who completed the Week 6 assessment.

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.

Outcome measures

Measure	Bilamellar 3 mm n=2132 Eyes 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	Bilamellar 5mm n=2136 Eyes 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	Trabut 3mm n=2148 Eyes 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
Number of Eyes With Presence of Pyogenic Granuloma at 6 Weeks	142 Eyes	109 Eyes	166 Eyes

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Bilamellar 3 mm n=1600 Participants 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	Bilamellar 5mm n=2290 Eyes 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	Trabut 3mm n=2268 Eyes 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
Number of Eyes With Presence of Pyogenic Granulomas Within 12 Months	147 Eyes	118 Eyes	170 Eyes

SECONDARY outcome

Timeframe: up to 3 Years

Population: Data reported for those participants who completed the Week 6, Month 12 and/or Year 3 assessment.

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.

Outcome measures

Measure	Bilamellar 3 mm n=2272 Eyes 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	Bilamellar 5mm n=2305 Eyes 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	Trabut 3mm n=2288 Eyes 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
Number of Eyes With Presence of Post-Operative Trichiasis Within 3 Years	451 Eyes	663 Eyes	401 Eyes

Adverse Events

Bilamellar 3 mm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 113 deaths

Bilamellar 5mm

Serious events: 1 serious events

Other events: 0 other events

Deaths: 103 deaths

Trabut 3mm

Serious events: 1 serious events

Other events: 0 other events

Deaths: 102 deaths

Serious adverse events

Measure	Bilamellar 3 mm n=1631 participants at risk 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	Bilamellar 5mm n=1648 participants at risk 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	Trabut 3mm n=1635 participants at risk 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
Hepatobiliary disorders Kidney Stones	0.00% 0/1631 • From the time of signing informed consent through 3 year follow-up.	0.06% 1/1648 • Number of events 1 • From the time of signing informed consent through 3 year follow-up.	0.00% 0/1635 • From the time of signing informed consent through 3 year follow-up.
Vascular disorders Whole Body Edema	0.00% 0/1631 • From the time of signing informed consent through 3 year follow-up.	0.00% 0/1648 • From the time of signing informed consent through 3 year follow-up.	0.06% 1/1635 • Number of events 1 • From the time of signing informed consent through 3 year follow-up.

Other adverse events

Adverse event data not reported

Additional Information

Emily Gower, PhD

University of North Carolina at Chapel Hill

Phone: 919-966-1420

Email: egower@unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place