Modified Instrumentation for Surgery to Correct Trichiasis (NCT00886015) | Clinical Trial Compass
CompletedNot Applicable
Modified Instrumentation for Surgery to Correct Trichiasis
United States1,927 participantsStarted 2009-05
Plain-language summary
Trachoma, an ocular infection caused by C. trachomatis, is the second leading infectious cause of blindness worldwide. Years of repeated infection with C. trachomatis cause the eyelid to scar and contract and ultimately to rotate inward such that the eyelashes rub against the eyeball and abrade the cornea (trichiasis). The World Health Organization (WHO) has endorsed a multi-faceted strategy to combat trachoma which includes surgery to repair lids distorted by trachoma (trichiasis) in imminent danger of vision loss. Current evidence suggests that long-term success rates of trichiasis surgery are less than optimal due to variation in surgical technique. Previous research by this study team has demonstrated that shorter incisions have a higher rate of trichiasis recurrence. In addition, observations by this team's oculoplastic surgeon have led to the hypothesis that granuloma formation and lid contour abnormalities may result from current surgical practices. The objective of this study is to compare outcomes of trichiasis surgeries performed with the newly developed trachomatous trichiasis (TT) clamp versus surgeries following standard technique (bilamellar tarsal rotation procedure or BLTR).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Presence of upper lid trichiasis: defined by at least one eyelash touching the globe of the eye or evidence of epilation
* No previous report of trichiasis surgery in at least one eye with trichiasis:
* eyes with prior surgery are already at high risk due to the prior surgery, and their inclusion may decrease our ability to clearly evaluate our primary outcome
* if unilateral surgery has been performed previously, only the eye without prior history of surgery will be in the study, even if both eyes require surgery
* Age 18 or older (in order to provide consent as an adult): the vast majority of trichiasis patients are aged 18 or older
* At time of enrollment, subjects must state their intention to remain in the area for two years to facilitate study follow-up
Exclusion Criteria:
* Absence of upper lid trichiasis
* Prior trichiasis surgery on both eyes
* Age 18 or younger
* Subjects who are transiently in the area
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial has already been completed, would you be able to share or look up what the results showed about recurrence rates of trichiasis after surgery — and how that might compare to what I could expect from standard surgical approaches?
2This study specifically tracked pyogenic granulomas as a complication after eyelid surgery — how common is that complication in general, and is it something I should be watching for after any trichiasis procedure I might have?
3The trial measured eyelid contour abnormalities as an outcome — can you explain what moderate or severe contour problems would mean for my vision and comfort, and how likely they are with the surgical technique you're recommending for me?
4Because this trial was listed as 'Phase NA,' meaning it wasn't testing a new drug but rather a modified surgical instrument or technique, can you tell me whether the approach studied here is now considered standard practice, or whether the older technique is still commonly used?
5Given that the trial focused on recurrent trichiasis as a key outcome, what are the realistic chances that trichiasis could come back after my surgery regardless of which technique is used, and what would the next steps be if it does recur?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Eyelids With Presence of Recurrent Trichiasis
Timeframe: 2 years
2
Number of Eyelids With Pyogenic Granuloma
Timeframe: 2 years
3
Number of Eyelids Experiencing an Unfavorable Outcome
Timeframe: 2 years
4
Number of Eyelids With Normal or Mild Eyelid Contour Abnormalities vs Moderate or Severe Eyelid Contour Abnormalities