Clinical Trial: Maximizing Trichiasis Surgery Success
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Evaluating the Role of Incision Height in Trichiasis Surgery Outcomes
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 3mm, bilamellar tarsal rotation surgery with an incision height of 5 mm, and Trabut surgery.
Detailed Summary: In this trial the investigators will randomize 3,972 individuals with previously unoperated trichiasis on a 1:1:1 basis to bilamellar tarsal rotation trichiasis surgery with an incision height of 3mm, bilamellar tarsal rotation trichiasis surgery with an incision height of 5mm, or Trabut surgery. Participants will receive trichiasis surgery then will be followed at 2 weeks, 6 weeks, and 12 months after surgery. 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.
Sponsor: University of North Carolina, Chapel Hill
Current Primary Outcome: Number of Eyes with Presence of Post-Operative Trichiasis at 12 Months [ Time Frame: 12 Months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of Eyes with Presence of Post-Operative Trichiasis at 6 Weeks [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 Weeks ]
The examiner will grade the presence of abnormality using a standardized definition. The field grade will serve as the primary grade for this measure. Presence or absence of eyelid contour abnormalities will be based on field gradings of mild, moderate, and severe abnormalities. Mild will be combined with "no abnormality" and moderate and severe will be combined to form the "moderate/severe contour abnormality" group.
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 [ Time Frame: 12 Months ]
The examiner will grade the presence of abnormality using a standardized definition. The field grade will serve as the primary grade for this measure. Presence or absence of eyelid contour abnormalities will be based on field gradings of mild, moderate, and severe abnormalities. Mild will be combined with "no abnormality" and moderate and severe will be combined to form the "moderate/severe contour abnormality" group.
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 [ Time Frame: 6 Weeks ]
The examiner will evaluate eyelid contour abnormalities and grade the presence of abnormality as mild, moderate, or severe. The photographic grade will be used for secondary analyses which require the full range of eyelid contour abnormalities.
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 [ Time Frame: 12 Months ]Same as current
Information By: University of North Carolina, Chapel Hill
Dates:
Date Received: February 27, 2017
Date Started: April 5, 2017
Date Completion: April 2019
Last Updated: April 25, 2017
Last Verified: April 2017
