- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03100747
Maximizing Trichiasis Surgery Success (MTSS)
Evaluating the Role of Incision Height in Trichiasis Surgery Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Southerns Nations, Nationalities, And Peoples' Region
-
Hosa'ina, Southerns Nations, Nationalities, And Peoples' Region, Ethiopia
- Orbis Ethiopia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- At least one eyelid with previously unoperated upper eyelid trichiasis
- Willing to comply with all study procedures and be available for the duration of the study
Exclusion Criteria:
- Inability to provide independent, informed consent
- All eyes with previously unoperated trichiasis are phthisical
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Bilamellar 3 mm
Bilamellar tarsal rotation trichiasis surgery involves a full-thickness incision through the upper eyelid.
For this arm, the height of the incision will be assigned at 3 mm from the eyelid margin.
|
Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 3 mm from the eyelid margin
Other Names:
|
Active Comparator: Bilamellar 5mm
Bilamellar tarsal rotation trichiasis surgery involves a full-thickness incision through the upper eyelid.
For this arm, the height of the incision will be assigned at 5 mm from the eyelid margin.
|
Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 5 mm from the eyelid margin
Other Names:
|
Active Comparator: Trabut 3mm
Trabut surgery involves a partial-thickness incision through the upper eyelid parallel to the eyelid margin.
For this surgery, the height of the incision will be assigned at 3 mm from the eyelid margin.
|
Trichiasis surgery using Trabut procedure with incision 3 mm from the eyelid margin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Eyes With Presence of Post-Operative Trichiasis Within 12 Months
Time Frame: 12 Months
|
Presence of post-operative trichiasis is defined as 1+ trichiatic eyelashes or evidence of recent epilation.
Any eyelashes touching the eye with the eye in primary gaze are considered to be trichiatic.
Outcomes will be evaluated at 6 weeks and 12 months.
The first date of post-operative trichiasis will be used as the outcome.
|
12 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity of Post-Operative Trichiasis at 6 Weeks
Time Frame: 6 Weeks
|
Severity of post-operative trichiasis will be graded as mild, moderate, or severe based on number of eyelashes touching globe and number of eyelashes epilated. Definitions for trichiasis severity are: 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 |
6 Weeks
|
Severity of Post-Operative Trichiasis at 12 Months
Time Frame: 12 Months
|
Severity of post-operative trichiasis will be graded as mild, moderate, or severe based on number of eyelashes touching globe and number of eyelashes epilated. Definitions for trichiasis severity are: 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 |
12 Months
|
Number of Eyes With Presence of Post-Operative Trichiasis at 6 Weeks
Time Frame: 6 Weeks
|
Presence of post-operative trichiasis is defined as 1+ trichiatic eyelashes or evidence of recent epilation.
Any eyelashes touching the eye with the eye in primary gaze are considered to be trichiatic.
|
6 Weeks
|
Number of Eyes With Presence of Eyelid Contour Abnormalities at 6 Weeks
Time Frame: 6 Weeks
|
A field and photograph examiner will grade the presence of abnormality independently, using a standardized definition. For this analysis, mild will be combined with normal to create "no significant abnormality" and moderate and severe will be combined into a "moderate/severe contour abnormality" group. The photographic grade will serve as the primary grade for this measure. Definitions for abnormality are: 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 |
6 Weeks
|
Number of Eyes With Presence of Eyelid Contour Abnormalities Within 12 Months
Time Frame: 12 Months
|
A field and photograph examiner will grade the presence of abnormality independently. For this analysis, mild is combined with normal to create "no significant abnormality" and moderate and severe are combined into a "moderate/severe contour abnormality" group. The photographic grade will serve as the primary grade. The 12 month dichotomous photograph grade will be the main eyelid contour abnormality (ECA) outcome. Data from the last completed visit (6 weeks or 12 months) are used. Definitions for abnormality are: 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 |
12 Months
|
Severity of Eyelid Contour Abnormalities at 6 Weeks
Time Frame: 6 Weeks
|
Using the grades obtained in the outcome above, the eyelid contour abnormality will be reported as none, mild, moderate, or severe. This is a secondary outcome and will only utilize the photograph grade for this outcome. Definitions for abnormality are: 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 |
6 Weeks
|
Severity of Eyelid Contour Abnormalities at 12 Months
Time Frame: 12 Months
|
The eyelid contour abnormality will be reported as none, mild, moderate, or severe. This is a secondary outcome and will only utilize the photograph grade for this outcome. Definitions for abnormality are: 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. |
12 Months
|
Number of Eyes With Changes in Eyelid Contour Abnormalities Between 6 Weeks and 1 Year
Time Frame: 12 months
|
The severity of eyelid contour abnormality can lessen over time.
The severity will be compared at 6 weeks and 12 months.
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12 months
|
Number of Eyes With Presence of Pyogenic Granuloma at 6 Weeks
Time Frame: 6 weeks
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Pyogenic granulomas occasionally develop after trichiasis surgery, and it is thought that these are a response to a foreign body, such as suture material or a jagged incision edge.
The patient examiners will evaluate presence of granulomas, and all granulomas will be noted, regardless of size.
|
6 weeks
|
Number of Eyes With Presence of Pyogenic Granulomas Within 12 Months
Time Frame: up to 12 Months
|
Pyogenic granulomas occasionally develop after trichiasis surgery, and it is thought that these are a response to a foreign body, such as suture material or a jagged incision edge.
The patient examiners will evaluate presence of granulomas, and all granulomas will be noted, regardless of size.
Data are included for both 6 weeks and 12 months.
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up to 12 Months
|
Number of Eyes With Presence of Post-Operative Trichiasis Within 3 Years
Time Frame: up to 3 Years
|
Presence of post-operative trichiasis is defined as 1+ trichiatic eyelashes or evidence of recent epilation.
Any eyelashes touching the eye with the eye in primary gaze are considered to be trichiatic.
Outcomes will be evaluated based on visits at 6 weeks, 12 months and/or Year 3.
|
up to 3 Years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Emily Gower, PhD, University of North Carolina, Chapel Hill
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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
Other Study ID Numbers
- 16-2878
- UG1EY025992 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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