Eye Diseases, Trachoma, Trichiasis
Conditions
Keywords
Surgery, Oculoplastics, trichiasis, trachoma
Brief summary
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.
Detailed description
The investigators will randomize 1000 individuals with post-operative trichiasis on a 1:1 basis to standard BLTR surgery or the recently developed Bevel-Rotate Advancement Procedure (B-RAP). Participants will receive trichiasis surgery and will be followed at 1 day, 2 weeks and 3, 6, 9 12, 18 and 24 months after surgery. The primary outcome is development of repeat post-operative trachomatous trichiasis (rPTT) within 12 months after surgery. Logistic regression analyses will be performed to compare the rates of PTT between the two procedures, controlling for demographic characteristics and pre-operative trichiasis severity. Secondary outcomes include pyogenic granuloma formation and eyelid contour abnormalities as well as patient-reported outcomes.
Interventions
PROCEDUREB-RAP
B-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.
PROCEDUREBLTR
A 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.
Sponsors
University of North Carolina, Chapel Hill
University of Virginia
University of Pennsylvania
Kongwa Trachoma Project
National Eye Institute (NEI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants and outcome examiners will be masked to treatment assignment. Field-based outcomes will be assessed in the field by masked outcome examiners (e.g. presence of rPTT, granuloma), and photograph-based outcomes (e.g., ECA) will be graded centrally at the data coordinating center in a masked fashion. Given the nature of the study, surgeons will not be masked.
Intervention model description
1:1 randomization at the person level, stratified by surgeon and baseline PTT severity (mild vs severe)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Unable to provide informed consent * All eyes with previously operated trichiasis that are phthisical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of eyelids with repeat postoperative trachomatous trichiasis (rPTT) within 12 months after surgery | >2 weeks after surgery to one year 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of eyelids with moderate/severe eyelid contour abnormalities (ECA) | Assessed at last study visit (max: 2 years) | 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 | >2 weeks and up to 12 months after surgery | 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 | Between two weeks and twenty four months after surgery | 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 | At first visit where rPTT is detected (up to 2 years after surgery) | 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) |
| Cumulative number of eyelids with pyogenic granuloma | Any time between surgery and 24 months after surgery | 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, 9, 12, 18 and 24 month visit s(including participants where the granuloma was removed) |
Countries
Tanzania, United States
Contacts
CONTACTEmily Gower, PhD
CONTACTJerusha Weaver, MPH
PRINCIPAL_INVESTIGATOREmily Gower, PhD
University of North Carolina, Chapel Hill
Outcome results
None listed