Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Modified Instrumentation for Surgery to Correct Trichiasis

This study has been completed.
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Emily Gower, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00886015
First received: April 21, 2009
Last updated: April 11, 2017
Last verified: April 2017
  Purpose
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).

Condition Intervention
Trachoma
Device: TT Clamp
Procedure: Standard BLTR Technique

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: Partnership for the Rapid Elimination of Trachoma (PRET) Clinical Trial of Evaluation of Modified Instrumentation for Surgery to Correct Trichiasis

Resource links provided by NLM:


Further study details as provided by Emily Gower, Johns Hopkins University:

Primary Outcome Measures:
  • Number of Eyelids With Presence of Recurrent Trichiasis [ Time Frame: 2 years ]
    Trichiasis: 1 or more eyelashes touching globe in primary position

  • Number of Eyelids With Pyogenic Granuloma [ Time Frame: 2 years ]
    A pyogenic granuloma was defined as a sessile growth of 2 mm or more in diameter on the tarsal conjunctiva.

  • Number of Eyelids Experiencing an Unfavorable Outcome [ Time Frame: 2 years ]
    At least 1 unfavorable outcome, including mild, moderate, or severe trichiasis; granuloma; or mild, moderate, or severe eyelid contour abnormality

  • Number of Eyelids With Normal or Mild Eyelid Contour Abnormalities vs Moderate or Severe Eyelid Contour Abnormalities [ Time Frame: 2 years ]

    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



Secondary Outcome Measures:
  • Number of Eyelids With Mild, Moderate, Severe, or no Eyelid Contour Abnormality [ Time Frame: 2 years ]

    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


  • Number of Eyelids With Normal, Mild, Moderate, or Severe Trachomatous Trichiasis [ Time Frame: 2 Years ]

    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



Enrollment: 1927
Study Start Date: May 2009
Study Completion Date: June 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TT Clamp
The TT clamp will be used in trichiasis surgery.
Device: TT Clamp
trichiasis surgery performed with TT clamp
Active Comparator: Standard BLTR Technique
Standard BLTR technique will be used in trichiasis surgery.
Procedure: Standard BLTR Technique
bilamellar tarsal rotation procedure in trichiasis surgery

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of upper lid trichiasis: defined by at least one eyelash touching the globe of the eye or evidence of epilation
  • No previous report of trichiasis surgery in at least one eye with trichiasis:

    • eyes with prior surgery are already at high risk due to the prior surgery, and their inclusion may decrease our ability to clearly evaluate our primary outcome
    • if unilateral surgery has been performed previously, only the eye without prior history of surgery will be in the study, even if both eyes require surgery
  • Age 18 or older (in order to provide consent as an adult): the vast majority of trichiasis patients are aged 18 or older
  • At time of enrollment, subjects must state their intention to remain in the area for two years to facilitate study follow-up

Exclusion Criteria:

  • Absence of upper lid trichiasis
  • Prior trichiasis surgery on both eyes
  • Age 18 or younger
  • Subjects who are transiently in the area
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886015

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Emily Gower, PhD Johns Hopkins University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Emily Gower, Associate Professor of Ophthalmology, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00886015     History of Changes
Other Study ID Numbers: NA_00019216
Study First Received: April 21, 2009
Results First Received: August 3, 2016
Last Updated: April 11, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Deidentified data will be provided to investigators through application to the data committee at Johns Hopkins University.

Keywords provided by Emily Gower, Johns Hopkins University:
Trachoma
trichiasis
bilamellar tarsal rotation procedure

Additional relevant MeSH terms:
Trachoma
Trichiasis
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections
Infection
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Eyelid Diseases

ClinicalTrials.gov processed this record on May 25, 2017