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Repeat Surgery for Patients With Post-operative Trachomatous Trichiasis Trial

Repeat Surgery for Patients With Post-operative Trachomatous Trichiasis Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03886519
Acronym
PTT
Enrollment
886
Registered
2019-03-22
Start date
2019-04-13
Completion date
2022-10-22
Last updated
2024-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery, Trichiasis

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

PROCEDUREBRAP (Bevel/rotate/advance procedure)

Trichiasis surgery using the BRAP procedure

PROCEDURETrabut

Trichiasis surgery using the Trabut procedure

Sponsors

Orbis
CollaboratorOTHER
National Eye Institute (NEI)
CollaboratorNIH
University of Maryland, Baltimore
CollaboratorOTHER
University of North Carolina, Chapel Hill
Lead SponsorOTHER

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

* 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

MeasureTime frameDescription
Number of Eyelids With Post-operative Trichiasis Within 12 Months10-20 monthsPresence 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

MeasureTime frameDescription
Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 Months3-6 monthsSeverity 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 Months10-20 monthsSeverity 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 System10-20 monthsThe 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 Months3-6 monthsPresence 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 Months10-20 monthsThe 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 Months10-20 monthsPyogenic 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 Months3-6 monthsThe 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

ArmCount
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
Total1,592

Baseline characteristics

CharacteristicBRAP (Bevel/Rotate/Advance Procedure)Trabut 3 mmTotal
Age, Customized
40-60 years
189 Participants193 Participants382 Participants
Age, Customized
<40 years
92 Participants75 Participants167 Participants
Age, Customized
>60 years
70 Participants81 Participants151 Participants
Baseline Trachomatous Trichiasis (TT) Severity
Mild
74 Eyes74 Eyes148 Eyes
Baseline Trachomatous Trichiasis (TT) Severity
Moderate
84 Eyes104 Eyes188 Eyes
Baseline Trachomatous Trichiasis (TT) Severity
Severe
288 Eyes268 Eyes556 Eyes
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
351 Participants349 Participants700 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
351 Participants349 Participants700 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
Ethiopia
351 participants349 participants700 participants
Sex: Female, Male
Female
285 Participants273 Participants558 Participants
Sex: Female, Male
Male
66 Participants76 Participants142 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
7 / 3516 / 349
other
Total, other adverse events
0 / 3510 / 349
serious
Total, serious adverse events
0 / 3510 / 349

Outcome results

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.

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.

ArmMeasureValue (COUNT_OF_UNITS)
BRAP (Bevel/Rotate/Advance Procedure)Number of Eyelids With Post-operative Trichiasis Within 12 Months94 Eyelids
Trabut 3 mmNumber of Eyelids With Post-operative Trichiasis Within 12 Months120 Eyelids
p-value: 0.0795% CI: [0.52, 1.03]Regression, Logistic
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.

Time frame: 10-20 months

Population: Analysis limited to eyelids with PTT at 3-6 months that also had a 12-month visit.

ArmMeasureCategoryValue (COUNT_OF_UNITS)
BRAP (Bevel/Rotate/Advance Procedure)Change in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading SystemNo change21 Eyelids
BRAP (Bevel/Rotate/Advance Procedure)Change in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading System1 category worse6 Eyelids
BRAP (Bevel/Rotate/Advance Procedure)Change in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading System2 categories worse1 Eyelids
Trabut 3 mmChange in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading SystemNo change43 Eyelids
Trabut 3 mmChange in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading System1 category worse1 Eyelids
Trabut 3 mmChange in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading System2 categories worse3 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.

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.

ArmMeasureValue (COUNT_OF_UNITS)
BRAP (Bevel/Rotate/Advance Procedure)Cumulative Number of Eyelids With Presence of Pyogenic Granulomas Within 10-20 Months3 eyelids
Trabut 3 mmCumulative Number of Eyelids With Presence of Pyogenic Granulomas Within 10-20 Months10 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.

Time frame: 10-20 months

ArmMeasureGroupValue (COUNT_OF_UNITS)
BRAP (Bevel/Rotate/Advance Procedure)Number of Eyelids With Each of the Trichiasis Severity Levels at 12 MonthsNone310 Eyelids
BRAP (Bevel/Rotate/Advance Procedure)Number of Eyelids With Each of the Trichiasis Severity Levels at 12 MonthsMild47 Eyelids
BRAP (Bevel/Rotate/Advance Procedure)Number of Eyelids With Each of the Trichiasis Severity Levels at 12 MonthsModerate24 Eyelids
BRAP (Bevel/Rotate/Advance Procedure)Number of Eyelids With Each of the Trichiasis Severity Levels at 12 MonthsSevere18 Eyelids
Trabut 3 mmNumber of Eyelids With Each of the Trichiasis Severity Levels at 12 MonthsSevere19 Eyelids
Trabut 3 mmNumber of Eyelids With Each of the Trichiasis Severity Levels at 12 MonthsNone281 Eyelids
Trabut 3 mmNumber of Eyelids With Each of the Trichiasis Severity Levels at 12 MonthsModerate23 Eyelids
Trabut 3 mmNumber of Eyelids With Each of the Trichiasis Severity Levels at 12 MonthsMild76 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

Time frame: 3-6 months

ArmMeasureGroupValue (COUNT_OF_UNITS)
BRAP (Bevel/Rotate/Advance Procedure)Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 MonthsNone284 Eyelids
BRAP (Bevel/Rotate/Advance Procedure)Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 MonthsMild21 Eyelids
BRAP (Bevel/Rotate/Advance Procedure)Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 MonthsModerate7 Eyelids
BRAP (Bevel/Rotate/Advance Procedure)Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 MonthsSevere5 Eyelids
Trabut 3 mmNumber of Eyelids With Each of the Trichiasis Severity Levels at 3-6 MonthsSevere6 Eyelids
Trabut 3 mmNumber of Eyelids With Each of the Trichiasis Severity Levels at 3-6 MonthsNone288 Eyelids
Trabut 3 mmNumber of Eyelids With Each of the Trichiasis Severity Levels at 3-6 MonthsModerate11 Eyelids
Trabut 3 mmNumber of Eyelids With Each of the Trichiasis Severity Levels at 3-6 MonthsMild32 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

Time frame: 10-20 months

ArmMeasureGroupValue (COUNT_OF_UNITS)
BRAP (Bevel/Rotate/Advance Procedure)Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 12 MonthsNone/Mild317 Eyelids
BRAP (Bevel/Rotate/Advance Procedure)Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 12 MonthsModerate/Severe82 Eyelids
Trabut 3 mmNumber of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 12 MonthsNone/Mild334 Eyelids
Trabut 3 mmNumber of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 12 MonthsModerate/Severe65 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

Time frame: 3-6 months

ArmMeasureGroupValue (COUNT_OF_UNITS)
BRAP (Bevel/Rotate/Advance Procedure)Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 3-6 MonthsNone/Mild225 Eyelids
BRAP (Bevel/Rotate/Advance Procedure)Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 3-6 MonthsModerate/Severe92 Eyelids
Trabut 3 mmNumber of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 3-6 MonthsNone/Mild236 Eyelids
Trabut 3 mmNumber of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 3-6 MonthsModerate/Severe101 Eyelids
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.

Time frame: 3-6 months

ArmMeasureValue (COUNT_OF_UNITS)
BRAP (Bevel/Rotate/Advance Procedure)Number of Eyelids With Presence of Post-operative Trichiasis Within 3-6 Months33 Eyelids
Trabut 3 mmNumber of Eyelids With Presence of Post-operative Trichiasis Within 3-6 Months49 Eyelids

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026