NCT00522860

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2008

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

January 12, 2012

Status Verified

January 1, 2012

Enrollment Period

2.2 years

First QC Date

August 28, 2007

Last Update Submit

January 11, 2012

Conditions

Trachomatous TrichiasisTrachoma

Keywords

TrichiasisTrachomaSurgerySutureEthiopia

Outcome Measures

Primary Outcomes (1)

  • Recurrent trichiasis

    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.

    One and two years

Secondary Outcomes (5)

  • Entropion

    One and two years

  • Corneal opacity

    One and two years

  • Visual Acuity Change

    One and Two years

  • Conjunctivilisation of the lid margin grade

    One and two years

  • Repeat Trichiasis Surgery

    At any time during two years followup.

Study Arms (2)

Vicryl Suture

EXPERIMENTAL

Vicryl sutures, 5/0, 3/8 curved cutting needle

Procedure: Trichiasis surgery with absorbable sutures

Silk Suture

ACTIVE COMPARATOR

Silk suture, 4/0, 3/8 curved cutting needle

Procedure: Trichiasis surgery with non-absorbable sutures

Interventions

Trichiasis surgery with absorbable suturesPROCEDURE

Posterior lamellar tarsal rotation. Vicryl sutures, 5/0, 3/8 curved needle, cutting. Three everting sutures.

Vicryl Suture
Trichiasis surgery with non-absorbable suturesPROCEDURE

Posterior lamellar tarsal rotation. Silk sutures. 4/0. 3/8 curved cutting needle. Three sets of everting sutures.

Silk Suture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major trichiasis: more than 5 lashes touching the eye

You may not qualify if:

  • Previous eyelid surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahir Dar Regional Health Bureau

Bahir Dar, Amhara, Ethiopia

Location

Related Publications (3)

  • Rajak SN, Habtamu E, Weiss HA, Kello AB, Gebre T, Genet A, Bailey RL, Mabey DC, Khaw PT, Gilbert CE, Emerson PM, Burton MJ. Absorbable versus silk sutures for surgical treatment of trachomatous trichiasis in Ethiopia: a randomised controlled trial. PLoS Med. 2011 Dec;8(12):e1001137. doi: 10.1371/journal.pmed.1001137. Epub 2011 Dec 13.

    PMID: 22180732RESULT

  • Gower EW, Munoz B, Rajak S, Habtamu E, West SK, Merbs SL, Harding JC, Alemayehu W, Callahan EK, Emerson PM, Gebre T, Burton MJ. Pre-operative trichiatic eyelash pattern predicts post-operative trachomatous trichiasis. PLoS Negl Trop Dis. 2019 Oct 7;13(10):e0007637. doi: 10.1371/journal.pntd.0007637. eCollection 2019 Oct.

    PMID: 31589610DERIVED

  • Rajak SN, Habtamu E, Weiss HA, Bedri A, Zerihun M, Gebre T, Gilbert CE, Emerson PM, Burton MJ. Why do people not attend for treatment for trachomatous trichiasis in Ethiopia? A study of barriers to surgery. PLoS Negl Trop Dis. 2012;6(8):e1766. doi: 10.1371/journal.pntd.0001766. Epub 2012 Aug 28.

    PMID: 22953007DERIVED

Related Links

MeSH Terms

Conditions

TrachomaTrichiasis

Condition Hierarchy (Ancestors)

Conjunctivitis, BacterialEye Infections, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsChlamydia InfectionsChlamydiaceae InfectionsGram-Negative Bacterial InfectionsEye InfectionsConjunctivitisConjunctival DiseasesEye DiseasesCorneal DiseasesEyelid Diseases

Study Officials

  • Matthew J Burton, PhD FRCOphth

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2007

First Posted

August 30, 2007

Study Start

March 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

January 12, 2012

Record last verified: 2012-01

Locations

ET(1)