The primary objective of this randomized clinical trial is to determine whether repeat trichiasis surgery performed with Bevel-Rotate Advancement Procedure (B-RAP) improves surgical success compared to Bilamellar Tarsal Rotation (BLTR) among a group of 8-10 TT surgeons in Tanzania. The study aims to enroll 1,000 individuals with PTT. The primary outcome is repeat PTT within one year after surgery. Additionally, the study will assess eyelid contour abnormalities and how they change over a two-year period as well as patient reported outcomes.
If this project is successful in improving surgical outcomes, it could change the approach to treating PTT globally. Individuals with trichiasis have a significantly reduced quality of life; correcting their trichiasis long-term has the potential to improve their quality of life and their family members' quality of life considerably.
One or both eyes with upper eyelid PTT, with a plan to undergo PTT surgery
Previous upper eyelid TT surgery in the study eye(s)
Collection of all baseline data prior to randomization
Signed, informed consent
Unable to provide informed consent
All eyes with previously operated trichiasis that are phthisical
Parallel
B-RAP
Procedure/SurgeryB-RAP uses an incision beveled toward the eyelashes to thin the distal fragment and allow access to and removal of scarring from previous surgery. The distal fragment is rotated and the tarsus and conjunctiva are advanced downward to further correct the PTT.
BLTR
Procedure/SurgeryA full-thickness incision is made through the anterior and posterior lamellae, parallel to and 3mm above the lid margin. Three sutures are placed externally to rotate and fix the eyelid.
Number of eyelids with repeat postoperative trachomatous trichiasis (rPTT) within 12 months after surgery
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. The outcome will be assessed at 3, 6, 9 and 12 months. If the eyelid has trichiasis at 2 weeks, but not at any future visit, the eyelid will not be considered to have rPTT.
Number of eyelids with moderate/severe eyelid contour abnormalities (ECA)
The grader 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. Results will be based on photograph grades. Category definitions 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
Number of eyelids with clinically significant rPTT by twelve months
Presence of clinically significant rPTT is defined as evidence of entropion AND either 1) \>2 lashes touching the eye peripherally (Not touching the cornea in primary gaze) or 2) at least one eyelash emanating from the central portion of the eyelid, touching the cornea in primary gaze. Trichiatic eyelashes are eyelashes touching the globe with the eye in primary gaze. The outcome will be assessed at 3, 6, 9 and 12 months. If the eyelid has trichiasis at 2 weeks, but not at any future visit, the eyelid will not be considered to have rPTT.
Number of eyelids with rPTT by 24 months
Presence of repeat 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. The outcome will be assessed at 3, 6, 9, 12, 18 and 24 months. If the eyelid has trichiasis at 2 weeks, but not at any future visit, the eyelid will not be considered to have rPTT.
Number of eyelids with each level of rPTT Severity
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)
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University of North Carolina, Chapel Hill
Lead sponsor
University of Virginia
Collaborator
University of Pennsylvania
Collaborator
Kongwa Trachoma Project
Collaborator
National Eye Institute (NEI)
Collaborator
