MTSS: Maximizing Trichiasis Surgery Success
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
Procedure: Bilamellar 3 mm
Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 3 mm from the eyelid margin
Other Names:
|
| Active Comparator: 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. |
Procedure: Bilamellar 5 mm
Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 5 mm from the eyelid margin
Other Names:
|
| Active Comparator: 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. |
Procedure: Trabut 3 mm
Trichiasis surgery using Trabut procedure with incision 3 mm from the eyelid margin
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Eyes with Presence of Post-Operative Trichiasis within12 Months [12 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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [12 months]
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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Orbis Ethiopia | Hosa'ina | Southerns Nations, Nationalities, And Peoples' Region | Ethiopia |
Sponsors and Collaborators
- University of North Carolina, Chapel Hill
- Orbis
- National Eye Institute (NEI)
- University of Maryland, Baltimore
Investigators
- Principal Investigator: Emily Gower, PhD, University of North Carolina, Chapel Hill
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 16-2878
- UG1EY025992