A Trial of Non-absorbable Versus Absorbable Sutures for Trichiasis Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00522860
First received: August 28, 2007
Last updated: January 11, 2012
Last verified: January 2012
  Purpose

Trachoma is the leading infectious cause of blindness worldwide. Recurrent infection by Chlamydia trachomatis causes in-turning of the eyelids / lashes (trichiasis), leading to corneal damage and blindness. The WHO recommends corrective eyelid surgery for trichiasis. Unfortunately, trichiasis frequently returns following surgery. The purpose of this study is to compare the outcome of surgery (at one and two years) for trichiasis using two currently used alternative suture types: non-absorbable (silk) and absorbable (vicryl). We, the researchers, hypothesise that the supportive presence of the absorbable suture for a longer period produces more stable wound healing, leading to a better outcome.


Condition Intervention Phase
Trachomatous Trichiasis
Trachoma
Procedure: Trichiasis surgery with absorbable sutures
Procedure: Trichiasis surgery with non-absorbable sutures
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Non-absorbable (Silk) Sutures Verses Absorbable (Vicryl) Sutures During the Surgical Treatment of Trachomatous Trichiasis

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Recurrent trichiasis [ Time Frame: One and two years ] [ Designated as safety issue: No ]
    Recurrent trichiasis, defined as one or more eyelashes touching the globe or evidence of epilation (lash stubs) on examination, or a history of repeat trichiasis surgery since the baseline surgery, at one year.


Secondary Outcome Measures:
  • Entropion [ Time Frame: One and two years ] [ Designated as safety issue: No ]
  • Corneal opacity [ Time Frame: One and two years ] [ Designated as safety issue: No ]
  • Visual Acuity Change [ Time Frame: One and Two years ] [ Designated as safety issue: No ]
  • Conjunctivilisation of the lid margin grade [ Time Frame: One and two years ] [ Designated as safety issue: No ]
  • Repeat Trichiasis Surgery [ Time Frame: At any time during two years followup. ] [ Designated as safety issue: No ]

Enrollment: 1300
Study Start Date: March 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vicryl Suture
Vicryl sutures, 5/0, 3/8 curved cutting needle
Procedure: Trichiasis surgery with absorbable sutures
Posterior lamellar tarsal rotation. Vicryl sutures, 5/0, 3/8 curved needle, cutting. Three everting sutures.
Active Comparator: Silk Suture
Silk suture, 4/0, 3/8 curved cutting needle
Procedure: Trichiasis surgery with non-absorbable sutures
Posterior lamellar tarsal rotation. Silk sutures. 4/0. 3/8 curved cutting needle. Three sets of everting sutures.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major trichiasis: more than 5 lashes touching the eye

Exclusion Criteria:

  • Previous eyelid surgery
  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: NCT00522860

Locations
Ethiopia
Bahir Dar Regional Health Bureau
Bahir Dar, Amhara, Ethiopia
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Investigators
Principal Investigator: Matthew J Burton, PhD FRCOphth London School of Hygiene and Tropical Medicine
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00522860     History of Changes
Other Study ID Numbers: 5025
Study First Received: August 28, 2007
Last Updated: January 11, 2012
Health Authority: United Kingdom: Research Ethics Committee
Ethiopia: Ethiopia Science and Technology Commission
United States: Institutional Review Board

Keywords provided by London School of Hygiene and Tropical Medicine:
Trichiasis
Trachoma
Surgery
Suture
Ethiopia

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

ClinicalTrials.gov processed this record on October 19, 2014