Repeat Surgery for Patients With Post-operative Trachomatous Trichiasis Trial

Surgery Clinical Trial

— PTT  

Official title:

Repeat Surgery for Patients With Post-operative Trachomatous Trichiasis Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03886519
• Other study ID #: 17-2766
• Secondary ID: UG1EY025992-04S1
• Status: Completed
• Phase: N/A
• Start date: April 13, 2019
• Est. completion date: October 22, 2022

Study information

• Verified date: August 2022
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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/rotate/advance procedure (BRAP), to the Trabut procedure among repeat surgery patients.

Description:

The investigators will randomize participants with previously operated trichiasis on a 1:1 basis to receive either the Bevel/rotate/advance procedure (BRAP) or the Trabut procedure. The participants will be followed at 1 day, 2 weeks, 3-6 months, and then 12 months following the surgery. The primary study endpoint is recurrence of post-operative trichiasis within 12 months of surgery. The investigators will conduct logistic regression analysis comparing post-operative trichiasis recurrent rates in participants receiving BRAP versus participants receiving Trabut. Adjusted analyses will account for demographic characteristics as well as trichiasis severity prior to surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 886
• Est. completion date: October 22, 2022
• Est. primary completion date: October 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 or older
• At least one eyelid with post-operative 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

Related Conditions & MeSH terms

• Surgery
• Trichiasis

Intervention

Procedure:
• BRAP (Bevel/rotate/advance procedure)
Trichiasis surgery using the BRAP procedure
• Trabut
Trichiasis surgery using the Trabut procedure

Locations

Country	Name	City	State
Ethiopia	Orbis Ethiopia	Hosa'ina	Southerns Nations, Nationalities, And Peoples' Region

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Eye Institute (NEI), Orbis, University of Maryland, Baltimore

Country where clinical trial is conducted

Ethiopia, 

References & Publications (1)

Gower EW, West SK, Cassard SD, Munoz BE, Harding JC, Merbs SL. Definitions and standardization of a new grading scheme for eyelid contour abnormalities after trichiasis surgery. PLoS Negl Trop Dis. 2012;6(6):e1713. doi: 10.1371/journal.pntd.0001713. Epub 2012 Jun 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Eyelids With Post-operative Trichiasis Within 12 Months	Presence of post-operative trichiasis defined as at least one trichiatic eyelashes or evidence of recent epilation. Trichiatic eyelashes are eyelashes touching the globe with the eye in the primary gaze. The outcome will be assessed at 3-6 months and at 12 months. If the eyelid has trichiasis at 2 weeks, but not at 3-6 months or 12 months, the eyelid will not be considered to have post-operative trichiasis. Due to COVID, the visit window for the Month 12 visits ranged from 10-20 months.	10-20 months
Secondary	Number of Eyelids With Presence of Post-operative Trichiasis Within 3-6 Months	Presence of post-operative trichiasis defined as at least one trichiatic eyelash or evidence of recent epilation. Trichiatic eyelashes are eyelashes touching the globe with the eye in primary gaze.	3-6 months
Secondary	Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 Months	Severity will be graded as mild, moderate, or severe based on the number of eyelashes touching the globe and the amount of eyelashes epilated.; Trichiasis severity will be defined using the following categories: i. Mild: 1-4 eyelashes touching globe and no epilation OR <1/3 eyelashes epilated and no eyelashes touching the globe ii. Moderate: 5-9 eyelashes touching globe and no epilation OR 1-4 eyelashes touching globe and <1/3 eyelashes epilated iii. Severe: 5-9 eyelashes touching globe and <1/3 eyelashes epilated OR 10+ eyelashes touching globe (regardless of epilation status) OR =1/3 eyelashes epilated (regardless of eyelashes touching globe) OR entire eyelid epilated	3-6 months
Secondary	Number of Eyelids With Each of the Trichiasis Severity Levels at 12 Months	Severity will be graded as mild, moderate, or severe based on the number of eyelashes touching the globe and the amount of eyelashes epilated.; Trichiasis severity will be defined using the following categories: i. Mild: 1-4 eyelashes touching globe and no epilation OR <1/3 eyelashes epilated and no eyelashes touching the globe ii. Moderate: 5-9 eyelashes touching globe and no epilation OR 1-4 eyelashes touching globe and <1/3 eyelashes epilated iii. Severe: 5-9 eyelashes touching globe and <1/3 eyelashes epilated OR 10+ eyelashes touching globe (regardless of epilation status) OR =1/3 eyelashes epilated (regardless of eyelashes touching globe) OR entire eyelid epilated.; Due to COVID, the visit window for the Month 12 visits ranged from 10-20 months.	10-20 months
Secondary	Change in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading System	The change in PTT severity between 3-6 months and 12 months will be measured in eyes with PTT at 3-6 months that also were examined at the 12-month visit. Change will be measured in the difference in the number of categories between 3-6 month and 1 year outcome. For example, Mild to Severe would be a 2 category change.	10-20 months
Secondary	Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 3-6 Months	The examiner will assess for eyelid contour abnormalities (ECA) and grade the abnormalities as mild, moderate, or severe. For the analysis, no abnormality and mild eyelid contour abnormality will be combined, and moderate and severe eyelid contour abnormality will be combined. For secondary analyses, the investigators will classify eyelid contour abnormalities using the photographs to capture the full range of ECA categories: none, mild, moderate, and severe.; The definitions for the categories are: 1) 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. 2) 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 3) 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 len	3-6 months
Secondary	Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 12 Months	The examiner in the field will assess for eyelid contour abnormalities and grade the abnormalities as mild, moderate, or severe. For the analysis, no abnormality and mild eyelid contour abnormality will be combined, and moderate and severe eyelid contour abnormality will be combined. For secondary analyses, the investigators will classify eyelid contour abnormalities using the photographs to capture the full range of ECA categories: none, mild, moderate, and severe.; The definitions for the categories are: 1) 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. 2) 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 3) 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	10-20 months
Secondary	Cumulative Number of Eyelids With Presence of Pyogenic Granulomas Within 10-20 Months	Pyogenic granulomas occasionally develop after trichiasis surgery. It is thought that this is a response to a foreign material, such as a sutures or an incision edge. All granulomas will be noted regardless of size. The investigators will count granulomas observed at the 3-6 month visit (including participants where the granuloma was removed) and granulomas observed at the 12 month visit. Due to COVID, the visit window for the Month 12 visits ranged from 10-20 months.	10-20 months