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Maximizing Trichiasis Surgery Success (MTSS)

Primary Purpose

Trichiasis, Surgery

Status
Completed
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
Bilamellar 3 mm
Bilamellar 5 mm
Trabut 3 mm
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trichiasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least one eyelid with previously unoperated upper eyelid trichiasis
  • Willing to comply with all study procedures and be available for the duration of the study

Exclusion Criteria:

  • Inability to provide independent, informed consent
  • All eyes with previously unoperated trichiasis are phthisical

Sites / Locations

  • Orbis Ethiopia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Bilamellar 3 mm

Bilamellar 5mm

Trabut 3mm

Arm Description

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 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.

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.

Outcomes

Primary Outcome Measures

Number of Eyes with Presence of Post-Operative Trichiasis within12 Months
Presence of post-operative trichiasis is defined as 1+ trichiatic eyelashes or evidence of recent epilation. Any eyelashes touching the eye with the eye in primary gaze are considered to be trichiatic. Outcomes will be evaluated at 6 weeks and 12 months. The first date of post-operative trichiasis will be used as the outcome.

Secondary Outcome Measures

Number of Eyes with Presence of Post-Operative Trichiasis at 6 Weeks
Presence of post-operative trichiasis is defined as 1+ trichiatic eyelashes or evidence of recent epilation. Any eyelashes touching the eye with the eye in primary gaze are considered to be trichiatic.
Severity of Post-Operative Trichiasis at 6 Weeks
Severity of post-operative trichiasis will be graded as mild, moderate, or severe based on number of eyelashes touching globe and number of eyelashes epilated. Definitions for trichiasis severity are: Mild: 1-4 Eyelashes touching globe, no epilation OR 1-10 Eyelashes epilated, no eyelashes touching globe; Moderate: 5-9 Eyelashes touching globe, no epilation OR 1-4 Eyelashes touching globe and 1-10 eyelashes epilated; Severe: 5-9 Eyelashes touching globe and 1-10 eyelashes epilated OR 10+ Eyelashes touching globe, regardless of epilation status OR 11-20 Eyelashes epilated, regardless of eyelashes touching globe OR Entire eyelid epilated
Severity of Post-Operative Trichiasis at 12 Months
Severity of post-operative trichiasis will be graded as mild, moderate, or severe based on number of eyelashes touching globe and number of eyelashes epilated. Definitions for trichiasis severity are: Mild: 1-4 Eyelashes touching globe, no epilation OR 1-10 Eyelashes epilated, no eyelashes touching globe; Moderate: 5-9 Eyelashes touching globe, no epilation OR 1-4 Eyelashes touching globe and 1-10 eyelashes epilated; Severe: 5-9 Eyelashes touching globe and 1-10 eyelashes epilated OR 10+ Eyelashes touching globe, regardless of epilation status OR 11-20 Eyelashes epilated, regardless of eyelashes touching globe OR Entire eyelid epilated
Number of Eyes with Presence of Eyelid Contour Abnormalities at 6 Weeks
A field and photograph examiner will grade the presence of abnormality independently, using a standardized definition. For this analysis, mild will be combined with normal to create "no significant abnormality" and moderate and severe will be combined into a "moderate/severe contour abnormality" group. The photographic grade will serve as the primary grade for this measure. We will conduct a secondary analysis using field grades. Definitions for abnormality are: Mild: Vertical deviation from the natural contour, 1 mm in height (less than half the pupil height in daylight) and affecting 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour 2 mm in height (more than the pupil height in daylight) or a defect >2/3 of the horizontal eyelid length
Number of Eyes with Presence of Eyelid Contour Abnormalities at 12 Months
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. We will conduct a secondary analysis using field grades. The 12 month dichotomous photograph grade will be the main ECA 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
Severity of Eyelid Contour Abnormalities at 6 Weeks
Using the grades obtained in the outcome above, we will report the eyelid contour abnormality as none, mild, moderate, or severe. This is a secondary outcome and we 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
Severity of Eyelid Contour Abnormalities at 12 Months
Using the grades obtained in the outcome above, we will report the eyelid contour abnormality as none, mild, moderate, or severe. This is a secondary outcome and we will only utilize the photograph grade for this outcome. Definitions for abnormality are: Mild: Vertical deviation from the natural contour, 1 mm in height (less than half the pupil height in daylight) and affecting 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour 2 mm in height (more than the pupil height in daylight) or a defect >2/3 of the horizontal eyelid length
Number of Eyes with Presence of Pyogenic Granulomas at 6 Weeks
Pyogenic granulomas occasionally develop after trichiasis surgery, and it is thought that these are a response to a foreign body, such as suture material or a jagged incision edge. The patient examiners will evaluate presence of granulomas, and all granulomas will be noted, regardless of size.
Number of Eyes with Presence of Pyogenic Granuloma at 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.
Change in Eyelid Contour Abnormalities Between 6 weeks and 1 year
The severity of eyelid contour abnormality can lessen over time. We will compare the severity at 6 weeks and 12 months and assess predictors of change in contour abnormality.

Full Information

First Posted
February 27, 2017
Last Updated
March 31, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Orbis, National Eye Institute (NEI), University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT03100747
Brief Title
Maximizing Trichiasis Surgery Success
Acronym
MTSS
Official Title
Evaluating the Role of Incision Height in Trichiasis Surgery Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 5, 2017 (Actual)
Primary Completion Date
June 2, 2022 (Actual)
Study Completion Date
June 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Orbis, National Eye Institute (NEI), University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether the rate of post-operative trachomatous trichiasis differs significantly between bilamellar tarsal rotation surgery with an incision height of 3 mm, bilamellar tarsal rotation surgery with an incision height of 5 mm, and Trabut surgery.
Detailed Description
In this trial the investigators will randomize 4,953 individuals with previously unoperated trichiasis on a 1:1:1 basis to bilamellar tarsal rotation trichiasis surgery with an incision height of 3 mm, bilamellar tarsal rotation trichiasis surgery with an incision height of 5 mm, or Trabut surgery. Participants will receive trichiasis surgery then will be followed at 1 day, 2 weeks, 6 weeks, and 12 months after surgery. Some participants may be asked to attend a follow-up visit at 3-6 months. The primary outcome is development of post-operative trachomatous trichiasis (PTT) within 12 months after surgery. Logistic regression analyses will be performed to compare the rates of PTT in the 3 versus 5 mm incision BLTR groups, in the 3 mm BLTR versus Trabut group, and in the 5 mm BLTR versus Trabut group, adjusting for demographic characteristics and pre-operative trichiasis severity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichiasis, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
4914 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bilamellar 3 mm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Bilamellar 5mm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Trabut 3mm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bilamellar 3 mm
Other Intervention Name(s)
Bilamellar Tarsal Rotation with 3 mm incision
Intervention Description
Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 3 mm from the eyelid margin
Intervention Type
Procedure
Intervention Name(s)
Bilamellar 5 mm
Other Intervention Name(s)
Bilamellar Tarsal Rotation with 5mm incision
Intervention Description
Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 5 mm from the eyelid margin
Intervention Type
Procedure
Intervention Name(s)
Trabut 3 mm
Other Intervention Name(s)
Trabut procedure with 3 mm incision
Intervention Description
Trichiasis surgery using Trabut procedure with incision 3 mm from the eyelid margin
Primary Outcome Measure Information:
Title
Number of Eyes with Presence of Post-Operative Trichiasis within12 Months
Description
Presence of post-operative trichiasis is defined as 1+ trichiatic eyelashes or evidence of recent epilation. Any eyelashes touching the eye with the eye in primary gaze are considered to be trichiatic. Outcomes will be evaluated at 6 weeks and 12 months. The first date of post-operative trichiasis will be used as the outcome.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Number of Eyes with Presence of Post-Operative Trichiasis at 6 Weeks
Description
Presence of post-operative trichiasis is defined as 1+ trichiatic eyelashes or evidence of recent epilation. Any eyelashes touching the eye with the eye in primary gaze are considered to be trichiatic.
Time Frame
6 Weeks
Title
Severity of Post-Operative Trichiasis at 6 Weeks
Description
Severity of post-operative trichiasis will be graded as mild, moderate, or severe based on number of eyelashes touching globe and number of eyelashes epilated. Definitions for trichiasis severity are: Mild: 1-4 Eyelashes touching globe, no epilation OR 1-10 Eyelashes epilated, no eyelashes touching globe; Moderate: 5-9 Eyelashes touching globe, no epilation OR 1-4 Eyelashes touching globe and 1-10 eyelashes epilated; Severe: 5-9 Eyelashes touching globe and 1-10 eyelashes epilated OR 10+ Eyelashes touching globe, regardless of epilation status OR 11-20 Eyelashes epilated, regardless of eyelashes touching globe OR Entire eyelid epilated
Time Frame
6 Weeks
Title
Severity of Post-Operative Trichiasis at 12 Months
Description
Severity of post-operative trichiasis will be graded as mild, moderate, or severe based on number of eyelashes touching globe and number of eyelashes epilated. Definitions for trichiasis severity are: Mild: 1-4 Eyelashes touching globe, no epilation OR 1-10 Eyelashes epilated, no eyelashes touching globe; Moderate: 5-9 Eyelashes touching globe, no epilation OR 1-4 Eyelashes touching globe and 1-10 eyelashes epilated; Severe: 5-9 Eyelashes touching globe and 1-10 eyelashes epilated OR 10+ Eyelashes touching globe, regardless of epilation status OR 11-20 Eyelashes epilated, regardless of eyelashes touching globe OR Entire eyelid epilated
Time Frame
12 Months
Title
Number of Eyes with Presence of Eyelid Contour Abnormalities at 6 Weeks
Description
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. We will conduct a secondary analysis using field grades. Definitions for abnormality are: Mild: Vertical deviation from the natural contour, 1 mm in height (less than half the pupil height in daylight) and affecting 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour 2 mm in height (more than the pupil height in daylight) or a defect >2/3 of the horizontal eyelid length
Time Frame
6 Weeks
Title
Number of Eyes with Presence of Eyelid Contour Abnormalities at 12 Months
Description
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. We will conduct a secondary analysis using field grades. The 12 month dichotomous photograph grade will be the main ECA outcome. Definitions for abnormality are: Mild: Vertical deviation from the natural contour, 1 mm in height (less than half the pupil height in daylight) and affecting 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour 2 mm in height (more than the pupil height in daylight) or a defect >2/3 of the horizontal eyelid length
Time Frame
12 Months
Title
Severity of Eyelid Contour Abnormalities at 6 Weeks
Description
Using the grades obtained in the outcome above, we will report the eyelid contour abnormality as none, mild, moderate, or severe. This is a secondary outcome and we will only utilize the photograph grade for this outcome. Definitions for abnormality are: Mild: Vertical deviation from the natural contour, 1 mm in height (less than half the pupil height in daylight) and affecting 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour 2 mm in height (more than the pupil height in daylight) or a defect >2/3 of the horizontal eyelid length
Time Frame
6 Weeks
Title
Severity of Eyelid Contour Abnormalities at 12 Months
Description
Using the grades obtained in the outcome above, we will report the eyelid contour abnormality as none, mild, moderate, or severe. This is a secondary outcome and we will only utilize the photograph grade for this outcome. Definitions for abnormality are: Mild: Vertical deviation from the natural contour, 1 mm in height (less than half the pupil height in daylight) and affecting 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour 2 mm in height (more than the pupil height in daylight) or a defect >2/3 of the horizontal eyelid length
Time Frame
12 Months
Title
Number of Eyes with Presence of Pyogenic Granulomas at 6 Weeks
Description
Pyogenic granulomas occasionally develop after trichiasis surgery, and it is thought that these are a response to a foreign body, such as suture material or a jagged incision edge. The patient examiners will evaluate presence of granulomas, and all granulomas will be noted, regardless of size.
Time Frame
6 Weeks
Title
Number of Eyes with Presence of Pyogenic Granuloma at 12 Months
Description
Pyogenic granulomas occasionally develop after trichiasis surgery, and it is thought that these are a response to a foreign body, such as suture material or a jagged incision edge. The patient examiners will evaluate presence of granulomas, and all granulomas will be noted, regardless of size.
Time Frame
12 months
Title
Change in Eyelid Contour Abnormalities Between 6 weeks and 1 year
Description
The severity of eyelid contour abnormality can lessen over time. We will compare the severity at 6 weeks and 12 months and assess predictors of change in contour abnormality.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least one eyelid with previously unoperated upper eyelid trichiasis Willing to comply with all study procedures and be available for the duration of the study Exclusion Criteria: Inability to provide independent, informed consent All eyes with previously unoperated trichiasis are phthisical
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Gower, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orbis Ethiopia
City
Hosa'ina
State/Province
Southerns Nations, Nationalities, And Peoples' Region
Country
Ethiopia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data will be shared with researchers on an as requested basis after the primary results paper has been published. Interested researchers can contact the principal investigator by email in order to request data and provide a data analysis plan.
IPD Sharing Time Frame
9 to 36 months following publication
IPD Sharing Access Criteria
Deidentified individual data that supports the results will be shared provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Citations:
PubMed Identifier
32193277
Citation
Bayissasse B, Sullivan KM, Merbs SL, Munoz B, Keil A, Sisay A, Singer A, Gower EW. Maximising trichiasis surgery success (MTSS) trial: rationale and design of a randomised controlled trial to improve trachomatous trichiasis surgical outcomes. BMJ Open. 2020 Mar 18;10(3):e036327. doi: 10.1136/bmjopen-2019-036327.
Results Reference
derived

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Maximizing Trichiasis Surgery Success

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