Surgery Clinical Trial
— MTSSOfficial title:
Evaluating the Role of Incision Height in Trichiasis Surgery Outcomes
Verified date | October 2023 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether the rate of post-operative trachomatous trichiasis differs significantly between bilamellar tarsal rotation surgery with an incision height of 3 mm, bilamellar tarsal rotation surgery with an incision height of 5 mm, and Trabut surgery.
Status | Completed |
Enrollment | 4914 |
Est. completion date | June 2, 2022 |
Est. primary completion date | June 2, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Ethiopia | Orbis Ethiopia | Hosa'ina | Southerns Nations, Nationalities, And Peoples' Region |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | National Eye Institute (NEI), Orbis, University of Maryland, Baltimore |
Ethiopia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Eyes With Presence of Post-Operative Trichiasis Within 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 | Number of Eyes With Presence of Post-Operative Trichiasis at 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 | |
Secondary | Severity of Post-Operative Trichiasis at 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 | |
Secondary | Severity of Post-Operative Trichiasis at 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 | |
Secondary | Number of Eyes With Presence of Eyelid Contour Abnormalities at 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 | |
Secondary | Number of Eyes With Presence of Eyelid Contour Abnormalities Within 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 | |
Secondary | Severity of Eyelid Contour Abnormalities at 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 | |
Secondary | Severity of Eyelid Contour Abnormalities at 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 | |
Secondary | Number of Eyes With Changes in Eyelid Contour Abnormalities Between 6 Weeks and 1 Year | The severity of eyelid contour abnormality can lessen over time. The severity will be compared at 6 weeks and 12 months. | 12 months | |
Secondary | Number of Eyes With Presence of Pyogenic Granuloma at 6 Weeks | 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 | |
Secondary | Number of Eyes With Presence of Pyogenic Granulomas Within 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. | up to 12 Months | |
Secondary | Number of Eyes With Presence of Post-Operative Trichiasis Within 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 |
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