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| ID | Type | Description | Link |
|---|---|---|---|
| UG1EY025992-04S1 | 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 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BRAP (Bevel/rotate/advance procedure) | Active Comparator | The BRAP procedure is a full-thickness beveled full-thickness incision |
|
| Trabut 3 mm | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BRAP (Bevel/rotate/advance procedure) | Procedure | Trichiasis surgery using the BRAP procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10-20 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3-6 months |
| Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 Months |
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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 |
|---|---|---|---|
| 22745845 | Background | Gower EW, West SK, Cassard SD, Munoz BE, Harding JC, Merbs SL. Definitions and standardization of a new grading scheme for eyelid contour abnormalities after trichiasis surgery. PLoS Negl Trop Dis. 2012;6(6):e1713. doi: 10.1371/journal.pntd.0001713. Epub 2012 Jun 26. |
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Deidentified data will be made available at the time of publication of the primary and pre-planned secondary results papers.
Deidentified individual data that support the results will be shared beginning 9 to 36 months following publication.
An investigator who proposes to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and execute a data use/sharing agreement with UNC.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | BRAP (Bevel/Rotate/Advance Procedure) | The Bevel/rotate/advance procedure (BRAP) involves a partial-thickness beveled incision and tarsal advancement. BRAP: Trichiasis surgery using the BRAP procedure |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Trabut 3 mm |
| 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 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. | 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. | Posted | Count of Units | Eyelids | 10-20 months | Eyelids | Eyelids |
|
From the time of signing informed consent through 10-20-month 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 | 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 |
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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 | May 8, 2020 | Jan 22, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058457 | Trichiasis |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D007291 | Inosine Monophosphate |
| ID | Term |
|---|---|
| D007292 | Inosine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Trabut | Procedure | Trichiasis surgery using the Trabut procedure |
|
|
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 |
| 3-6 months |
| 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. | 10-20 months |
| 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. | 10-20 months |
| 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 | 3-6 months |
| 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 | 10-20 months |
| 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. | 10-20 months |
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 |
| BG002 | Total | Total of all reporting groups |
| Eyes |
|
| Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| Baseline Trachomatous Trichiasis (TT) Severity | Trichiasis severity will be graded as mild, moderate, or severe based on number of eyelashes touching globe and number of eyelashes epilated. Definitions: 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 | Count of Units | Eyes | Eyes |
|
The BRAP procedure is a partial-thickness beveled incision
BRAP (Bevel/rotate/advance procedure): Trichiasis surgery using the BRAP procedure
| OG001 | 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 |
|
|
|
| Secondary | 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. | Posted | Count of Units | Eyelids | 3-6 months | Eyelids | Eyelids |
|
|
|
| Secondary | 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 | Posted | Count of Units | Eyelids | 3-6 months | Eyelids | Eyelids |
|
|
|
| Secondary | 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. | Posted | Count of Units | Eyelids | 10-20 months | Eyelids | Eyelids |
|
|
|
| Secondary | 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. | Analysis limited to eyelids with PTT at 3-6 months that also had a 12-month visit. | Posted | Count of Units | Eyelids | 10-20 months | Eyelids | Eyelids |
|
|
|
| Secondary | 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 | Posted | Count of Units | Eyelids | 3-6 months | Eyelids | Eyelids |
|
|
|
| Secondary | 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 | Posted | Count of Units | Eyelids | 10-20 months | Eyelids | Eyelids |
|
|
|
| Secondary | 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. | 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. | Posted | Count of Units | eyelids | 10-20 months | eyelids | eyelids |
|
|
|
| 7 |
| 351 |
| 0 |
| 351 |
| 0 |
| 351 |
| EG001 | 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 | 6 | 349 | 0 | 349 | 0 | 349 |
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| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|
| 2 categories worse |
|