Modified Instrumentation for Surgery to Correct Trichiasis

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Brief Title

Modified Instrumentation for Surgery to Correct Trichiasis

Official Title

Partnership for the Rapid Elimination of Trachoma (PRET) Clinical Trial of Evaluation of Modified Instrumentation for Surgery to Correct Trichiasis

Brief Summary

      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).
    

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.
    


Study Type

Interventional


Primary Outcome

Number of Eyelids With Presence of Recurrent Trichiasis

Secondary Outcome

 Number of Eyelids With Mild, Moderate, Severe, or no Eyelid Contour Abnormality

Condition

Trachoma

Intervention

TT Clamp

Study Arms / Comparison Groups

 TT Clamp
Description:  The TT clamp will be used in trichiasis surgery.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

1927

Start Date

May 2009

Completion Date

June 2012

Primary Completion Date

January 2012

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Emily Gower, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00886015

Organization ID

NA_00019216


Responsible Party

Principal Investigator

Study Sponsor

Johns Hopkins University

Collaborators

 Bill and Melinda Gates Foundation

Study Sponsor

Emily Gower, PhD, Principal Investigator, Johns Hopkins University


Verification Date

April 2017