TrachomaNCT00886015
Modified Instrumentation for Surgery to Correct Trichiasis
A study testing TT Clamp and Standard BLTR Technique in people with Trachoma, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trachoma
- What is being tested?
- TT Clamp and Standard BLTR Technique
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,927 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Absence of upper lid trichiasis
- Prior trichiasis surgery on both eyes
- Age 18 or younger
- Subjects who are transiently in the area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Partnership for the Rapid Elimination of Trachoma (PRET) Clinical Trial of Evaluation of Modified Instrumentation for Surgery to Correct Trichiasis
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).
Read the 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.
- Conditions
- Trachoma
- Being tested
- TT Clamp, Standard BLTR Technique
- Keywords
- Trachoma, trichiasis, bilamellar tarsal rotation procedure
- Medical subject headings
- Trachoma, Trichiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TT ClampDevice
trichiasis surgery performed with TT clamp
Standard BLTR TechniqueProcedure or surgery
bilamellar tarsal rotation procedure in trichiasis surgery
| Study group | Role | What they receive |
|---|---|---|
| TT Clamp | Experimental | The TT clamp will be used in trichiasis surgery. Receives: Device: TT Clamp |
| Standard BLTR Technique | Active comparator | Standard BLTR technique will be used in trichiasis surgery. Receives: Procedure: Standard BLTR Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Eyelids With Presence of Recurrent Trichiasis
Trichiasis: 1 or more eyelashes touching globe in primary position
Measured: 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.
Measured: 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
Measured: 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
Measured: 2 years
Secondary outcomes (2)
Number of Eyelids With Mild, Moderate, Severe, or no Eyelid Contour Abnormality
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
Measured: 2 years
Number of Eyelids With Normal, Mild, Moderate, or Severe Trachomatous Trichiasis
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
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionJan 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TrachomaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,927 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Emily Gower, Johns Hopkins University
- Investigators
- Emily Gower, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886015
- Sponsor's protocol ID
- NA_00019216
- Status last verified
- Apr 2017
- First submitted
- 21 Apr 2009
- Last updated
- 19 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Deidentified data will be provided to investigators through application to the data committee at Johns Hopkins University.
Publications
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.
PubMed 31589610Gower 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.
PubMed 23494035
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnership for the Rapid Elimination of Trachoma (PRET) Clinical Trial of Evaluation of Modified Instrumentation for Surgery to Correct Trichiasis
- ClinicalTrials.gov ID
- NCT00886015
- Acronym / sponsor ID
- NA_00019216
- Conditions
- Trachoma
- Keywords
- Trachoma, trichiasis, bilamellar tarsal rotation procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,927 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- May 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 22 Apr 2009 (estimated)
- Results
- Posted 19 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TT Clamp | Experimental | Device: TT ClampThe TT clamp will be used in trichiasis surgery. |
| Standard BLTR Technique | Active comparator | Procedure: Standard BLTR TechniqueStandard BLTR technique will be used in trichiasis surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- 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
Key exclusion criteria (4 listed)
- Absence of upper lid trichiasis
- Prior trichiasis surgery on both eyes
- Age 18 or younger
- Subjects who are transiently in the area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TT Clamptrichiasis surgery performed with TT clamp | Device | TT Clamp |
| Standard BLTR Techniquebilamellar tarsal rotation procedure in trichiasis surgery | Procedure or surgery | Standard BLTR Technique |
Primary outcome
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
2 secondary outcomes
Number of Eyelids With Mild, Moderate, Severe, or no Eyelid Contour Abnormality
Time frame: 2 years
Number of Eyelids With Normal, Mild, Moderate, or Severe Trachomatous Trichiasis
Time frame: 2 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31589610Gower 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.
- Derived from this study: PubMed 23494035Gower 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.
- Individual participant dataSharing planned: Yes. Deidentified data will be provided to investigators through application to the data committee at Johns Hopkins University.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Gower, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TT Clamp and Standard BLTR Technique in people with Trachoma, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Eyelids With Presence of Recurrent Trichiasis (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00886015, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2017; AzTrials last refreshed its copy on 26 Oct 2026.