- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00886015
Modified Instrumentation for Surgery to Correct Trichiasis
Partnership for the Rapid Elimination of Trachoma (PRET) Clinical Trial of Evaluation of Modified Instrumentation for Surgery to Correct Trichiasis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Field observations in 2005 by this study's PI and oculoplastic surgeon revealed some significant departures from current trichiasis surgery procedure (bilamellar tarsal rotation procedure or BTRP), as described in the WHO manual, "Trichiasis Surgery for Trachoma-the Bilamellar Tarsal Rotation Procedure". These procedural departures were felt to contribute to adverse outcomes, including trichiasis recurrence, granuloma formation and lid contour abnormalities. This study team developed a new surgical tool, the TT clamp, to help improve surgical outcomes following BLTR.
A randomized, single-masked clinical trial will be implemented in the Mtwara region in Tanzania. Study participants will be randomized on a 1:1 basis to surgery with the TT clamp or to surgery with standard BLTR equipment. All surgeries will take place at surgical centers in Mtwara and Lindi over an 8-month period.
Baseline assessment for severity of trichiasis and other predictors of surgical failure will be carried out prior to surgery. Follow-up is planned at 2 weeks (for suture removal), 6 weeks, 12 months, and 24 months post-surgery. At each follow-up visit participants will be assessed for evidence of unfavorable outcomes, including trichiasis recurrence, granuloma formation, and lid contour abnormalities. All outcomes will be assessed clinically by a trained observer who is masked to intervention status.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: TT Clamp
The TT clamp will be used in trichiasis surgery.
|
trichiasis surgery performed with TT clamp
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ACTIVE_COMPARATOR: Standard BLTR Technique
Standard BLTR technique will be used in trichiasis surgery.
|
bilamellar tarsal rotation procedure in trichiasis surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Eyelids With Presence of Recurrent Trichiasis
Time Frame: 2 years
|
Trichiasis: 1 or more eyelashes touching globe in primary position
|
2 years
|
Number of Eyelids With Pyogenic Granuloma
Time Frame: 2 years
|
A pyogenic granuloma was defined as a sessile growth of 2 mm or more in diameter on the tarsal conjunctiva.
|
2 years
|
Number of Eyelids Experiencing an Unfavorable Outcome
Time Frame: 2 years
|
At least 1 unfavorable outcome, including mild, moderate, or severe trichiasis; granuloma; or mild, moderate, or severe eyelid contour abnormality
|
2 years
|
Number of Eyelids With Normal or Mild Eyelid Contour Abnormalities vs Moderate or Severe Eyelid Contour Abnormalities
Time Frame: 2 years
|
Eyelid contour abnormalities (ECA) were graded by photographs of the eyes. In the primary outcome measure, normal eyes and mild eyelid contour abnormalities are considered together, and moderate or severe eyelid contour abnormalities are considered together. ECA severity is defined as follows: 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 |
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Eyelids With Mild, Moderate, Severe, or no Eyelid Contour Abnormality
Time Frame: 2 years
|
Eyelid contour abnormalities (ECA) were graded by photographs of the eyes. ECA severity is defined as follows: 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 |
2 years
|
Number of Eyelids With Normal, Mild, Moderate, or Severe Trachomatous Trichiasis
Time Frame: 2 Years
|
Trichiasis is generally defined as 1 or more eyelashes touching globe in primary position. Classifications of trichiasis severity are as follows: 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, regardless of eyelashes touching globe |
2 Years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Emily Gower, PhD, Johns Hopkins University
Publications and helpful links
General Publications
- Gower EW, Munoz B, Rajak S, Habtamu E, West SK, Merbs SL, Harding JC, Alemayehu W, Callahan EK, Emerson PM, Gebre T, Burton MJ. Pre-operative trichiatic eyelash pattern predicts post-operative trachomatous trichiasis. PLoS Negl Trop Dis. 2019 Oct 7;13(10):e0007637. doi: 10.1371/journal.pntd.0007637. eCollection 2019 Oct.
- Gower EW, West SK, Harding JC, Cassard SD, Munoz BE, Othman MS, Kello AB, Merbs SL. Trachomatous trichiasis clamp vs standard bilamellar tarsal rotation instrumentation for trichiasis surgery: results of a randomized clinical trial. JAMA Ophthalmol. 2013 Mar;131(3):294-301. doi: 10.1001/jamaophthalmol.2013.910.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Eye Diseases
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Conjunctivitis
- Conjunctival Diseases
- Corneal Diseases
- Chlamydiaceae Infections
- Eyelid Diseases
- Eye Infections, Bacterial
- Eye Infections
- Chlamydia Infections
- Conjunctivitis, Bacterial
- Trachoma
- Trichiasis
Other Study ID Numbers
- NA_00019216
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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