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Completed

NCT Number: NCT03100747

Maximizing Trichiasis Surgery Success

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.

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Key information

Conditions

Trichiasis Eye Diseases Eyelid Diseases Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orbis Ethiopia

Hosa’ina, Southerns Nations, Nationalities, and Peoples' Region, Ethiopia

About this study

In this trial the investigators will randomize 4,953 individuals with previously unoperated trichiasis on a 1:1:1 basis to bilamellar tarsal rotation trichiasis surgery with an incision height of 3 mm, bilamellar tarsal rotation trichiasis surgery with an incision height of 5 mm, or Trabut surgery. Participants will receive trichiasis surgery then will be followed at 1 day, 2 weeks, 6 weeks, and 12 months after surgery. Some participants may be asked to attend a follow-up visit at 3-6 months. The primary outcome is development of post-operative trachomatous trichiasis (PTT) within 12 months after surgery. Logistic regression analyses will be performed to compare the rates of PTT in the 3 versus 5 mm incision bilamellar tarsal rotation (BLTR) groups, in the 3 mm BLTR versus Trabut group, and in the 5 mm BLTR versus Trabut group, adjusting for demographic characteristics and pre-operative trichiasis severity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bilamellar 3 mm

Procedure

Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 3 mm from the eyelid margin

Other names: Bilamellar Tarsal Rotation with 3 mm incision

Bilamellar 5 mm

Procedure

Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 5 mm from the eyelid margin

Other names: Bilamellar Tarsal Rotation with 5mm incision

Trabut 3 mm

Procedure

Trichiasis surgery using Trabut procedure with incision 3 mm from the eyelid margin

Other names: Trabut procedure with 3 mm incision

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. Number of Eyes With Presence of Pyogenic Granuloma at 6 Weeks

    Time frame: 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.

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Eye Institute (NEI)
  • Orbis
  • University of Maryland, Baltimore

Registry information

Official study title

Evaluating the Role of Incision Height in Trichiasis Surgery Outcomes

Acronym: MTSS

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Apr 4, 2017
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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