Trachoma, an ocular infection caused by C. trachomatis, is the second leading infectious cause of blindness worldwide. Years of repeated infection with C. trachomatis cause the eyelid to scar and contract and ultimately to rotate inward such that the eyelashes rub against the eyeball and abrade the cornea (trichiasis). The World Health Organization (WHO) has endorsed a multi-faceted strategy to combat trachoma which includes surgery to repair lids distorted by trachoma (trichiasis) in imminent danger of vision loss. Current evidence suggests that long-term success rates of trichiasis surgery are less than optimal due to variation in surgical technique. Previous research by this study team has demonstrated that shorter incisions have a higher rate of trichiasis recurrence. In addition, observations by this team's oculoplastic surgeon have led to the hypothesis that granuloma formation and lid contour abnormalities may result from current surgical practices. The objective of this study is to compare outcomes of trichiasis surgeries performed with the newly developed trachomatous trichiasis (TT) clamp versus surgeries following standard technique (bilamellar tarsal rotation procedure or BLTR).
Field observations in 2005 by this study's PI and oculoplastic surgeon revealed some significant departures from current trichiasis surgery procedure (bilamellar tarsal rotation procedure or BTRP), as described in the WHO manual, "Trichiasis Surgery for Trachoma-the Bilamellar Tarsal Rotation Procedure". These procedural departures were felt to contribute to adverse outcomes, including trichiasis recurrence, granuloma formation and lid contour abnormalities. This study team developed a new surgical tool, the TT clamp, to help improve surgical outcomes following BLTR. A randomized, single-masked clinical trial will be implemented in the Mtwara region in Tanzania. Study participants will be randomized on a 1:1 basis to surgery with the TT clamp or to surgery with standard BLTR equipment. All surgeries will take place at surgical centers in Mtwara and Lindi over an 8-month period. Baseline assessment for severity of trichiasis and other predictors of surgical failure will be carried out prior to surgery. Follow-up is planned at 2 weeks (for suture removal), 6 weeks, 12 months, and 24 months post-surgery. At each follow-up visit participants will be assessed for evidence of unfavorable outcomes, including trichiasis recurrence, granuloma formation, and lid contour abnormalities. All outcomes will be assessed clinically by a trained observer who is masked to intervention status.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,927
trichiasis surgery performed with TT clamp
bilamellar tarsal rotation procedure in trichiasis surgery
Johns Hopkins University
Baltimore, Maryland, United States
Number of Eyelids With Presence of Recurrent Trichiasis
Trichiasis: 1 or more eyelashes touching globe in primary position
Time frame: 2 years
Number of Eyelids With Pyogenic Granuloma
A pyogenic granuloma was defined as a sessile growth of 2 mm or more in diameter on the tarsal conjunctiva.
Time frame: 2 years
Number of Eyelids Experiencing an Unfavorable Outcome
At least 1 unfavorable outcome, including mild, moderate, or severe trichiasis; granuloma; or mild, moderate, or severe eyelid contour abnormality
Time frame: 2 years
Number of Eyelids With Normal or Mild Eyelid Contour Abnormalities vs Moderate or Severe Eyelid Contour Abnormalities
Eyelid contour abnormalities (ECA) were graded by photographs of the eyes. In the primary outcome measure, normal eyes and mild eyelid contour abnormalities are considered together, and moderate or severe eyelid contour abnormalities are considered together. ECA severity is defined as follows: 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
Time frame: 2 years
Number of Eyelids With Mild, Moderate, Severe, or no Eyelid Contour Abnormality
Eyelid contour abnormalities (ECA) were graded by photographs of the eyes. ECA severity is defined as follows: 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
Time frame: 2 years
Number of Eyelids With Normal, Mild, Moderate, or Severe Trachomatous Trichiasis
Trichiasis is generally defined as 1 or more eyelashes touching globe in primary position. Classifications of trichiasis severity are as follows: 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, regardless of eyelashes touching globe
Time frame: 2 Years
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