Modified Instrumentation for Surgery to Correct Trichiasis

NCT00886015 | Completed Results DMC

• 1 other identifier: NA_00019216
• Study Type: interventional
• Target: 1,927
• Locations: 1 country
• Sites: 1

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).

Conditions

Trachoma

Keywords

Trachoma; trichiasis; bilamellar tarsal rotation procedure

Outcome Measures

Primary Outcomes (4)

• Number of Eyelids With Presence of Recurrent Trichiasis

  Trichiasis: 1 or more eyelashes touching globe in primary position

  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.

  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

  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

  2 years

Secondary Outcomes (2)

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

  2 years

• Number of Eyelids With Normal, Mild, Moderate, or Severe Trachomatous Trichiasis

  2 Years

Study Arms (2)

TT Clamp

EXPERIMENTAL

The TT clamp will be used in trichiasis surgery.

Device: TT Clamp

Standard BLTR Technique

ACTIVE COMPARATOR

Standard BLTR technique will be used in trichiasis surgery.

Procedure: Standard BLTR Technique

Interventions

TT Clamp DEVICE

trichiasis surgery performed with TT clamp

TT Clamp

Standard BLTR Technique PROCEDURE

bilamellar tarsal rotation procedure in trichiasis surgery

Standard BLTR Technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• Absence of upper lid trichiasis
• Prior trichiasis surgery on both eyes
• Age 18 or younger
• Subjects who are transiently in the area

Sponsors & Collaborators

• Johns Hopkins University: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

• 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: 31589610 DERIVED

• Gower EW, West SK, Harding JC, Cassard SD, Munoz BE, Othman MS, Kello AB, Merbs SL. Trachomatous trichiasis clamp vs standard bilamellar tarsal rotation instrumentation for trichiasis surgery: results of a randomized clinical trial. JAMA Ophthalmol. 2013 Mar;131(3):294-301. doi: 10.1001/jamaophthalmol.2013.910.

  PMID: 23494035 DERIVED

MeSH Terms

Conditions

Trachoma; Trichiasis

Condition Hierarchy (Ancestors)

Conjunctivitis, Bacterial; Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Chlamydia Infections; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Corneal Diseases; Eyelid Diseases

Results Point of Contact

• Title: Sheila West
• Organization: JohnHopkins U

shwest@jhmi.edu

410-955-2606

Study Officials

• Emily Gower, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology

Study Record Dates

• First Submitted: April 21, 2009
• First Posted: April 22, 2009
• Study Start: May 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 19, 2017
• Results First Posted: May 19, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)