BLTR vs B-RAP for Trichiasis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two types of surgery, B-RAP and BLTR, to determine which better treats trichiasis, a condition where eyelashes grow inward and irritate the eye. The researchers aim to identify which surgery results in fewer repeat issues and better eyelid shape over time. Candidates for this trial include those who have had trichiasis surgery before but still experience problems with their upper eyelid. Improving this surgery can significantly enhance the quality of life for those affected. As an unphased trial, this study allows participants to contribute to advancements in surgical techniques that could improve outcomes for future patients.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that these surgical procedures are safe for trichiasis treatment?
Research has shown that both the B-RAP and BLTR methods for trichiasis surgery have been studied. Early results for the B-RAP method suggest it could benefit those needing another surgery due to recurrent trichiasis. However, detailed safety information about B-RAP remains limited.
For the BLTR method, some studies have reported negative outcomes. Specifically, one study found that 21.4% of patients experienced a return of trichiasis within a year. Although BLTR is a well-known method, patients might still encounter issues post-surgery.
In summary, B-RAP is a newer method with promise, while BLTR is established but presents its own challenges. Prospective clinical trial participants should consider these findings when deciding.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it compares two surgical techniques for trichiasis: the traditional Bilamellar Tarsal Rotation (BLTR) and the experimental Bevel/Rotate/Advance Procedure (B-RAP). The B-RAP technique is unique because it introduces a novel method of rotating and advancing the eyelid margin to address misdirected eyelashes. Unlike the standard BLTR, which focuses on rotating the eyelid, B-RAP aims to enhance precision and potentially reduce recurrence rates by incorporating advanced beveling and rotation steps. Researchers hope to find out if B-RAP offers better long-term outcomes and fewer complications compared to BLTR, which could lead to improved quality of life for patients with trichiasis.
What evidence suggests that this trial's treatments could be effective for trichiasis?
This trial will compare the Bevel-Rotate Advancement Procedure (B-RAP) with the Bilamellar Tarsal Rotation (BLTR) procedure for treating trichiasis, a condition where eyelashes grow inward. Research suggests that B-RAP could improve outcomes for those needing repeat surgery. Early findings indicate that B-RAP might lower the risk of trichiasis recurrence after surgery. In comparison, studies show that the BLTR procedure has about a 21.4% chance of trichiasis returning within a year. Both procedures aim to treat trichiasis, but B-RAP is being studied for potentially better long-term results. Current evidence supports its potential to reduce the need for repeat surgeries.12367
Who Is on the Research Team?
Emily Gower, PhD
Principal Investigator
University of North Carolina, Chapel Hill
Are You a Good Fit for This Trial?
This trial is for individuals in Tanzania who have had previous upper eyelid surgery for trichiasis and are planning to undergo another one. They must have collected all baseline data and signed an informed consent form.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo trichiasis surgery using either the B-RAP or BLTR procedure
Follow-up
Participants are monitored for repeat post-operative trachomatous trichiasis (rPTT) and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- BLTR
- B-RAP
Trial Overview
The RESTORE trial is comparing two surgical techniques, B-RAP and BLTR, to see which is more successful at treating repeat trichiasis. The goal is to determine if one method can prevent the condition from returning within a year after surgery.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Trichiasis surgery using the B-RAP procedure.
Trichiasis surgery using the BLTR procedure.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor
University of Virginia
Collaborator
Kongwa Trachoma Project
Collaborator
National Eye Institute (NEI)
Collaborator
University of Pennsylvania
Collaborator
Citations
RESTORE: Comparing Two Approaches to Repeat TT ...
The primary outcome is development of repeat post-operative trachomatous trichiasis (rPTT) within 12 months after surgery. Logistic regression ...
A New Surgical Technique for Post-Operative Trachomatous ...
B-RAP shows promise as a procedure for improving outcomes of repeat trichiasis surgery.
BLTR vs B-RAP for Trichiasis · Info for Participants
The RESTORE trial is comparing two surgical techniques, B-RAP and BLTR, to see which is more successful at treating repeat trichiasis. The goal ...
4.
ctv.veeva.com
ctv.veeva.com/study/restore-comparing-two-approaches-to-repeat-tt-surgery-performed-by-integrated-eye-care-workers-iecComparing Two Approaches to Repeat TT Surgery Performed ...
The primary outcome is development of repeat post-operative trachomatous trichiasis (rPTT) within 12 months after surgery. Logistic regression ...
Repeat Surgery for Patients with Post-Operative Trichiasis ( ...
Here, we propose to conduct a clinical trial comparing a recently developed procedure, the bevel/rotate/advance procedure (BRAP), to the current ...
6.
clinicaltrials.gov
clinicaltrials.gov/study/NCT03886519?term=AREA%5BConditionSearch%5D(%22Trichiasis%22)&rank=7Repeat Surgery for Patients With Post-operative ...
The objective of this study is to determine if there is a significant difference in post-operative trichiasis at 12 months comparing a new procedure, the Bevel/ ...
7.
researchgate.net
researchgate.net/publication/354879977_A_New_Surgical_Technique_for_Postoperative_Trachomatous_TrichiasisA New Surgical Technique for Postoperative Trachomatous ...
B-RAP shows promise as a procedure for improving outcomes of repeat trichiasis surgery.
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