Surgery, Trichiasis
Conditions
Brief summary
The objective of this study is to determine if there is a significant difference in post-operative trichiasis at 12 months comparing a new procedure, the Bevel/rotate/advance procedure (BRAP), to the Trabut procedure among repeat surgery patients.
Detailed description
The investigators will randomize participants with previously operated trichiasis on a 1:1 basis to receive either the Bevel/rotate/advance procedure (BRAP) or the Trabut procedure. The participants will be followed at 1 day, 2 weeks, 3-6 months, and then 12 months following the surgery. The primary study endpoint is recurrence of post-operative trichiasis within 12 months of surgery. The investigators will conduct logistic regression analysis comparing post-operative trichiasis recurrent rates in participants receiving BRAP versus participants receiving Trabut. Adjusted analyses will account for demographic characteristics as well as trichiasis severity prior to surgery.
Interventions
Trichiasis surgery using the BRAP procedure
Trichiasis surgery using the Trabut procedure
Sponsors
Study design
Eligibility
Inclusion criteria
* Aged 18 or older * At least one eyelid with post-operative 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Eyelids With Post-operative Trichiasis Within 12 Months | 10-20 months | Presence of post-operative trichiasis defined as at least one trichiatic eyelashes or evidence of recent epilation. Trichiatic eyelashes are eyelashes touching the globe with the eye in the primary gaze. The outcome will be assessed at 3-6 months and at 12 months. If the eyelid has trichiasis at 2 weeks, but not at 3-6 months or 12 months, the eyelid will not be considered to have post-operative trichiasis. Due to COVID, the visit window for the Month 12 visits ranged from 10-20 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 Months | 3-6 months | Severity will be graded as mild, moderate, or severe based on the number of eyelashes touching the globe and the amount of eyelashes epilated. Trichiasis severity will be defined using the following categories: i. Mild: 1-4 eyelashes touching globe and no epilation OR \<1/3 eyelashes epilated and no eyelashes touching the globe ii. Moderate: 5-9 eyelashes touching globe and no epilation OR 1-4 eyelashes touching globe and \<1/3 eyelashes epilated iii. Severe: 5-9 eyelashes touching globe and \<1/3 eyelashes epilated OR 10+ eyelashes touching globe (regardless of epilation status) OR ≥1/3 eyelashes epilated (regardless of eyelashes touching globe) OR entire eyelid epilated |
| Number of Eyelids With Each of the Trichiasis Severity Levels at 12 Months | 10-20 months | Severity will be graded as mild, moderate, or severe based on the number of eyelashes touching the globe and the amount of eyelashes epilated. Trichiasis severity will be defined using the following categories: i. Mild: 1-4 eyelashes touching globe and no epilation OR \<1/3 eyelashes epilated and no eyelashes touching the globe ii. Moderate: 5-9 eyelashes touching globe and no epilation OR 1-4 eyelashes touching globe and \<1/3 eyelashes epilated iii. Severe: 5-9 eyelashes touching globe and \<1/3 eyelashes epilated OR 10+ eyelashes touching globe (regardless of epilation status) OR ≥1/3 eyelashes epilated (regardless of eyelashes touching globe) OR entire eyelid epilated. Due to COVID, the visit window for the Month 12 visits ranged from 10-20 months. |
| Change in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading System | 10-20 months | The change in PTT severity between 3-6 months and 12 months will be measured in eyes with PTT at 3-6 months that also were examined at the 12-month visit. Change will be measured in the difference in the number of categories between 3-6 month and 1 year outcome. For example, Mild to Severe would be a 2 category change. |
| Number of Eyelids With Presence of Post-operative Trichiasis Within 3-6 Months | 3-6 months | Presence of post-operative trichiasis defined as at least one trichiatic eyelash or evidence of recent epilation. Trichiatic eyelashes are eyelashes touching the globe with the eye in primary gaze. |
| Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 12 Months | 10-20 months | The examiner in the field will assess for eyelid contour abnormalities and grade the abnormalities as mild, moderate, or severe. For the analysis, no abnormality and mild eyelid contour abnormality will be combined, and moderate and severe eyelid contour abnormality will be combined. For secondary analyses, the investigators will classify eyelid contour abnormalities using the photographs to capture the full range of ECA categories: none, mild, moderate, and severe. The definitions for the categories are: 1) 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. 2) 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 3) 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 |
| Cumulative Number of Eyelids With Presence of Pyogenic Granulomas Within 10-20 Months | 10-20 months | Pyogenic granulomas occasionally develop after trichiasis surgery. It is thought that this is a response to a foreign material, such as a sutures or an incision edge. All granulomas will be noted regardless of size. The investigators will count granulomas observed at the 3-6 month visit (including participants where the granuloma was removed) and granulomas observed at the 12 month visit. Due to COVID, the visit window for the Month 12 visits ranged from 10-20 months. |
| Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 3-6 Months | 3-6 months | The examiner will assess for eyelid contour abnormalities (ECA) and grade the abnormalities as mild, moderate, or severe. For the analysis, no abnormality and mild eyelid contour abnormality will be combined, and moderate and severe eyelid contour abnormality will be combined. For secondary analyses, the investigators will classify eyelid contour abnormalities using the photographs to capture the full range of ECA categories: none, mild, moderate, and severe. The definitions for the categories are: 1) 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. 2) 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 3) 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 len |
Countries
Ethiopia
Participant flow
Pre-assignment details
A total of 886 participants were enrolled. Of those enrolled, 700 received surgery in accordance with the surgical protocol and the analyses are based on these participants.
Participants by arm
| Arm | Count |
|---|---|
| BRAP (Bevel/Rotate/Advance Procedure) The BRAP procedure involves a partial-thickness beveled incision, tarsal advancement and rotation
BRAP (Bevel/rotate/advance procedure): Trichiasis surgery using the BRAP procedure | 351 |
| BRAP (Bevel/Rotate/Advance Procedure) The BRAP procedure involves a partial-thickness beveled incision, tarsal advancement and rotation
BRAP (Bevel/rotate/advance procedure): Trichiasis surgery using the BRAP procedure | 446 |
| Trabut 3 mm The Trabut procedure is a partial-thickness incision through the tarsal conjunctiva and tarsus parallel to the eyelid margin and 3 mm above the lash line.
Trabut: Trichiasis surgery using the Trabut procedure | 349 |
| Trabut 3 mm The Trabut procedure is a partial-thickness incision through the tarsal conjunctiva and tarsus parallel to the eyelid margin and 3 mm above the lash line.
Trabut: Trichiasis surgery using the Trabut procedure | 446 |
| Total | 1,592 |
Baseline characteristics
| Characteristic | BRAP (Bevel/Rotate/Advance Procedure) | Trabut 3 mm | Total |
|---|---|---|---|
| Age, Customized 40-60 years | 189 Participants | 193 Participants | 382 Participants |
| Age, Customized <40 years | 92 Participants | 75 Participants | 167 Participants |
| Age, Customized >60 years | 70 Participants | 81 Participants | 151 Participants |
| Baseline Trachomatous Trichiasis (TT) Severity Mild | 74 Eyes | 74 Eyes | 148 Eyes |
| Baseline Trachomatous Trichiasis (TT) Severity Moderate | 84 Eyes | 104 Eyes | 188 Eyes |
| Baseline Trachomatous Trichiasis (TT) Severity Severe | 288 Eyes | 268 Eyes | 556 Eyes |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 351 Participants | 349 Participants | 700 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 351 Participants | 349 Participants | 700 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Ethiopia | 351 participants | 349 participants | 700 participants |
| Sex: Female, Male Female | 285 Participants | 273 Participants | 558 Participants |
| Sex: Female, Male Male | 66 Participants | 76 Participants | 142 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 351 | 6 / 349 |
| other Total, other adverse events | 0 / 351 | 0 / 349 |
| serious Total, serious adverse events | 0 / 351 | 0 / 349 |
Outcome results
Number of Eyelids With Post-operative Trichiasis Within 12 Months
Presence of post-operative trichiasis defined as at least one trichiatic eyelashes or evidence of recent epilation. Trichiatic eyelashes are eyelashes touching the globe with the eye in the primary gaze. The outcome will be assessed at 3-6 months and at 12 months. If the eyelid has trichiasis at 2 weeks, but not at 3-6 months or 12 months, the eyelid will not be considered to have post-operative trichiasis. Due to COVID, the visit window for the Month 12 visits ranged from 10-20 months.
Time frame: 10-20 months
Population: Data reported for those participants who completed the Month 3-6 and/or Month 12 assessments. A participant could have one or two eyes eligible for the study based on the number of eyes with TT prior to surgery.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| BRAP (Bevel/Rotate/Advance Procedure) | Number of Eyelids With Post-operative Trichiasis Within 12 Months | 94 Eyelids |
| Trabut 3 mm | Number of Eyelids With Post-operative Trichiasis Within 12 Months | 120 Eyelids |
Change in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading System
The change in PTT severity between 3-6 months and 12 months will be measured in eyes with PTT at 3-6 months that also were examined at the 12-month visit. Change will be measured in the difference in the number of categories between 3-6 month and 1 year outcome. For example, Mild to Severe would be a 2 category change.
Time frame: 10-20 months
Population: Analysis limited to eyelids with PTT at 3-6 months that also had a 12-month visit.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| BRAP (Bevel/Rotate/Advance Procedure) | Change in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading System | No change | 21 Eyelids |
| BRAP (Bevel/Rotate/Advance Procedure) | Change in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading System | 1 category worse | 6 Eyelids |
| BRAP (Bevel/Rotate/Advance Procedure) | Change in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading System | 2 categories worse | 1 Eyelids |
| Trabut 3 mm | Change in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading System | No change | 43 Eyelids |
| Trabut 3 mm | Change in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading System | 1 category worse | 1 Eyelids |
| Trabut 3 mm | Change in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading System | 2 categories worse | 3 Eyelids |
Cumulative Number of Eyelids With Presence of Pyogenic Granulomas Within 10-20 Months
Pyogenic granulomas occasionally develop after trichiasis surgery. It is thought that this is a response to a foreign material, such as a sutures or an incision edge. All granulomas will be noted regardless of size. The investigators will count granulomas observed at the 3-6 month visit (including participants where the granuloma was removed) and granulomas observed at the 12 month visit. Due to COVID, the visit window for the Month 12 visits ranged from 10-20 months.
Time frame: 10-20 months
Population: Data reported for those participants who completed the Month 3-6 and/or Month 12 assessments. A participant could have one or two eyes eligible for the study based on the number of eyes with TT prior to surgery.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| BRAP (Bevel/Rotate/Advance Procedure) | Cumulative Number of Eyelids With Presence of Pyogenic Granulomas Within 10-20 Months | 3 eyelids |
| Trabut 3 mm | Cumulative Number of Eyelids With Presence of Pyogenic Granulomas Within 10-20 Months | 10 eyelids |
Number of Eyelids With Each of the Trichiasis Severity Levels at 12 Months
Severity will be graded as mild, moderate, or severe based on the number of eyelashes touching the globe and the amount of eyelashes epilated. Trichiasis severity will be defined using the following categories: i. Mild: 1-4 eyelashes touching globe and no epilation OR \<1/3 eyelashes epilated and no eyelashes touching the globe ii. Moderate: 5-9 eyelashes touching globe and no epilation OR 1-4 eyelashes touching globe and \<1/3 eyelashes epilated iii. Severe: 5-9 eyelashes touching globe and \<1/3 eyelashes epilated OR 10+ eyelashes touching globe (regardless of epilation status) OR ≥1/3 eyelashes epilated (regardless of eyelashes touching globe) OR entire eyelid epilated. Due to COVID, the visit window for the Month 12 visits ranged from 10-20 months.
Time frame: 10-20 months
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| BRAP (Bevel/Rotate/Advance Procedure) | Number of Eyelids With Each of the Trichiasis Severity Levels at 12 Months | None | 310 Eyelids |
| BRAP (Bevel/Rotate/Advance Procedure) | Number of Eyelids With Each of the Trichiasis Severity Levels at 12 Months | Mild | 47 Eyelids |
| BRAP (Bevel/Rotate/Advance Procedure) | Number of Eyelids With Each of the Trichiasis Severity Levels at 12 Months | Moderate | 24 Eyelids |
| BRAP (Bevel/Rotate/Advance Procedure) | Number of Eyelids With Each of the Trichiasis Severity Levels at 12 Months | Severe | 18 Eyelids |
| Trabut 3 mm | Number of Eyelids With Each of the Trichiasis Severity Levels at 12 Months | Severe | 19 Eyelids |
| Trabut 3 mm | Number of Eyelids With Each of the Trichiasis Severity Levels at 12 Months | None | 281 Eyelids |
| Trabut 3 mm | Number of Eyelids With Each of the Trichiasis Severity Levels at 12 Months | Moderate | 23 Eyelids |
| Trabut 3 mm | Number of Eyelids With Each of the Trichiasis Severity Levels at 12 Months | Mild | 76 Eyelids |
Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 Months
Severity will be graded as mild, moderate, or severe based on the number of eyelashes touching the globe and the amount of eyelashes epilated. Trichiasis severity will be defined using the following categories: i. Mild: 1-4 eyelashes touching globe and no epilation OR \<1/3 eyelashes epilated and no eyelashes touching the globe ii. Moderate: 5-9 eyelashes touching globe and no epilation OR 1-4 eyelashes touching globe and \<1/3 eyelashes epilated iii. Severe: 5-9 eyelashes touching globe and \<1/3 eyelashes epilated OR 10+ eyelashes touching globe (regardless of epilation status) OR ≥1/3 eyelashes epilated (regardless of eyelashes touching globe) OR entire eyelid epilated
Time frame: 3-6 months
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| BRAP (Bevel/Rotate/Advance Procedure) | Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 Months | None | 284 Eyelids |
| BRAP (Bevel/Rotate/Advance Procedure) | Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 Months | Mild | 21 Eyelids |
| BRAP (Bevel/Rotate/Advance Procedure) | Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 Months | Moderate | 7 Eyelids |
| BRAP (Bevel/Rotate/Advance Procedure) | Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 Months | Severe | 5 Eyelids |
| Trabut 3 mm | Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 Months | Severe | 6 Eyelids |
| Trabut 3 mm | Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 Months | None | 288 Eyelids |
| Trabut 3 mm | Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 Months | Moderate | 11 Eyelids |
| Trabut 3 mm | Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 Months | Mild | 32 Eyelids |
Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 12 Months
The examiner in the field will assess for eyelid contour abnormalities and grade the abnormalities as mild, moderate, or severe. For the analysis, no abnormality and mild eyelid contour abnormality will be combined, and moderate and severe eyelid contour abnormality will be combined. For secondary analyses, the investigators will classify eyelid contour abnormalities using the photographs to capture the full range of ECA categories: none, mild, moderate, and severe. The definitions for the categories are: 1) 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. 2) 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 3) 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: 10-20 months
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| BRAP (Bevel/Rotate/Advance Procedure) | Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 12 Months | None/Mild | 317 Eyelids |
| BRAP (Bevel/Rotate/Advance Procedure) | Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 12 Months | Moderate/Severe | 82 Eyelids |
| Trabut 3 mm | Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 12 Months | None/Mild | 334 Eyelids |
| Trabut 3 mm | Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 12 Months | Moderate/Severe | 65 Eyelids |
Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 3-6 Months
The examiner will assess for eyelid contour abnormalities (ECA) and grade the abnormalities as mild, moderate, or severe. For the analysis, no abnormality and mild eyelid contour abnormality will be combined, and moderate and severe eyelid contour abnormality will be combined. For secondary analyses, the investigators will classify eyelid contour abnormalities using the photographs to capture the full range of ECA categories: none, mild, moderate, and severe. The definitions for the categories are: 1) 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. 2) 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 3) 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 len
Time frame: 3-6 months
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| BRAP (Bevel/Rotate/Advance Procedure) | Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 3-6 Months | None/Mild | 225 Eyelids |
| BRAP (Bevel/Rotate/Advance Procedure) | Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 3-6 Months | Moderate/Severe | 92 Eyelids |
| Trabut 3 mm | Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 3-6 Months | None/Mild | 236 Eyelids |
| Trabut 3 mm | Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 3-6 Months | Moderate/Severe | 101 Eyelids |
Number of Eyelids With Presence of Post-operative Trichiasis Within 3-6 Months
Presence of post-operative trichiasis defined as at least one trichiatic eyelash or evidence of recent epilation. Trichiatic eyelashes are eyelashes touching the globe with the eye in primary gaze.
Time frame: 3-6 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| BRAP (Bevel/Rotate/Advance Procedure) | Number of Eyelids With Presence of Post-operative Trichiasis Within 3-6 Months | 33 Eyelids |
| Trabut 3 mm | Number of Eyelids With Presence of Post-operative Trichiasis Within 3-6 Months | 49 Eyelids |