Maximizing Trichiasis Surgery Success (MTSS)

University of North Carolina (UNC)

Status: Completed

Conditions: Surgery; Trichiasis

Treatments: Procedure: Bilamellar 5 mm; Procedure: Bilamellar 3 mm; Procedure: Trabut 3 mm

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03100747

UG1EY025992 (U.S. NIH Grant/Contract)

16-2878

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 4,914 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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4,914 participants in 3 patient groups

Bilamellar 3 mm

Active Comparator group

Description:

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.

Treatment:

Procedure: Bilamellar 3 mm

Bilamellar 5mm

Active Comparator group

Description:

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.

Treatment:

Procedure: Bilamellar 5 mm

Trabut 3mm

Active Comparator group

Description:

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.

Treatment:

Procedure: Trabut 3 mm