Trachomatous TrichiasisNCT00522912
A Trial of Epilation Verses Surgery for Minor Trichiasis
A study testing Trichiasis surgery and Epilation in people with Trachomatous Trichiasis, run by London School of Hygiene and Tropical Medicine at 1 site in Ethiopia.
Trial summary
Trachoma is the leading infectious cause of blindness worldwide. Recurrent infection by Chlamydia trachomatis causes a gradual scarring process of the inner surface of the eyelid (conjunctiva) leading to in-turning of the eyelids (entropion) and lashes touching the eye (trichiasis). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trachomatous Trichiasis
- What is being tested?
- Trichiasis surgery and Epilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 1 siteEthiopia
- Study dates
- Mar 2008to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Minor trichiasis: 1 - 5 lashes touching the eye
Who cannot join
- Previous eyelid surgery.
- Patients with evidence of corneal damage (will be offered surgery).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial of Epilation Verses Immediate Surgery for the Management of Minor Trachomatous Trichiasis
Trachoma is the leading infectious cause of blindness worldwide. Recurrent infection by Chlamydia trachomatis causes a gradual scarring process of the inner surface of the eyelid (conjunctiva) leading to in-turning of the eyelids (entropion) and lashes touching the eye (trichiasis). The rate of progression and the severity of disease are variable. Some people develop severe disease with extensive entropion and trichiasis, whilst others have a mild problem with only a few lashes touching the eye, which does not progress.
In more advanced cases there is a broad consensus that the entropion / trichiasis should be corrected by surgery. In mild cases (minor trichiasis: 1-5 lashes touching the eye) the optimal treatment is uncertain. Some advocate early surgery to turn the eyelid out for any individual with one or more lashes touching any part of the eye. Others consider this to be too early for surgical intervention, as surgery can have a high recurrence rate and complications can arise. Instead, they recommend that minor trichiasis can be managed by epilation (pulling out lashes with forceps). In many endemic regions the uptake of surgery is low, with many patients preferring to epilate for mild disease.
The primary purpose of this study is to compare the outcome of immediate surgery to regular epilation for the management of minor trichiasis. The epilation would be done by a person with good eyesight using proper epilation forceps.
- Conditions
- Trachomatous Trichiasis
- Being tested
- Trichiasis surgery, Epilation
- Keywords
- Trachoma, Trichiasis, Surgery, Epilation, Ethiopia
- Medical subject headings
- Trachoma, Trichiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trichiasis surgeryProcedure or surgery
Posterior lamella tarsal rotation
EpilationProcedure or surgery
Epilation of lashes by another well sighted person using quality epilating forceps
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Immediate posterior lamella tarsal rotation surgery for minor trichiasis Receives: Procedure: Trichiasis surgery |
| B | Active comparator | Regular epilation by another person Receives: Procedure: Epilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trichiasis
Measured: One and two years
Secondary outcomes (2)
Visual acuity
Measured: One and two years
Corneal opacity
Measured: One and two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2007 (estimated)
- Study startMar 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Trachomatous TrichiasisStudies of the same condition, open and under way.
- 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
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew J Burton, PhD FRCOphth, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522912
- Sponsor's protocol ID
- 5024
- Status last verified
- Jan 2012
- First submitted
- 28 Aug 2007
- Last updated
- 12 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rajak SN, Habtamu E, Weiss HA, Kello AB, Gebre T, Genet A, Bailey RL, Mabey DC, Khaw PT, Gilbert CE, Emerson PM, Burton MJ. Surgery versus epilation for the treatment of minor trichiasis in Ethiopia: a randomised controlled noninferiority trial. PLoS Med. 2011 Dec;8(12):e1001136. doi: 10.1371/journal.pmed.1001136. Epub 2011 Dec 13.
PubMed 22180731Gower 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 31589610Rajak 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.
PubMed 22953007
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Epilation Verses Immediate Surgery for the Management of Minor Trachomatous Trichiasis
- ClinicalTrials.gov ID
- NCT00522912
- Acronym / sponsor ID
- 5024
- Conditions
- Trachomatous Trichiasis
- Keywords
- Trachoma, Trichiasis, Surgery, Epilation, Ethiopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 30 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Trachoma is the leading infectious cause of blindness worldwide. Recurrent infection by Chlamydia trachomatis causes a gradual scarring process of the inner surface of the eyelid (conjunctiva) leading to in-turning of the eyelids (entropion) and lashes touching the eye (trichiasis). The rate of progression and the severity of disease are variable. Some people develop severe disease with extensive entropion and trichiasis, whilst others have a mild problem with only a few lashes touching the eye, which does not progress.
In more advanced cases there is a broad consensus that the entropion / trichiasis should be corrected by surgery. In mild cases (minor trichiasis: 1-5 lashes touching the eye) the optimal treatment is uncertain. Some advocate early surgery to turn the eyelid out for any individual with one or more lashes touching any part of the eye. Others consider this to be too early for surgical intervention, as surgery can have a high recurrence rate and complications can arise. Instead, they recommend that minor trichiasis can be managed by epilation (pulling out lashes with forceps). In many endemic regions the uptake of surgery is low, with many patients preferring to epilate for mild disease.
The primary purpose of this study is to compare the outcome of immediate surgery to regular epilation for the management of minor trichiasis. The epilation would be done by a person with good eyesight using proper epilation forceps.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Trichiasis surgeryImmediate posterior lamella tarsal rotation surgery for minor trichiasis |
| B | Active comparator | Procedure: EpilationRegular epilation by another person |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Minor trichiasis: 1 - 5 lashes touching the eye
Key exclusion criteria (2 listed)
- Previous eyelid surgery.
- Patients with evidence of corneal damage (will be offered surgery).
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 |
|---|---|---|
| Trichiasis surgeryPosterior lamella tarsal rotation | Procedure or surgery | A |
| EpilationEpilation of lashes by another well sighted person using quality epilating forceps | Procedure or surgery | B |
Primary outcome
Trichiasis
Time frame: One and two years
2 secondary outcomes
Visual acuity
Time frame: One and two years
Corneal opacity
Time frame: One and two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2012.
- Results publication: PubMed 22180731Rajak SN, Habtamu E, Weiss HA, Kello AB, Gebre T, Genet A, Bailey RL, Mabey DC, Khaw PT, Gilbert CE, Emerson PM, Burton MJ. Surgery versus epilation for the treatment of minor trichiasis in Ethiopia: a randomised controlled noninferiority trial. PLoS Med. 2011 Dec;8(12):e1001136. doi: 10.1371/journal.pmed.1001136. Epub 2011 Dec 13.
- 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 22953007Rajak 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.
- Published ResultsLink provided by the sponsor.
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.
Matthew J Burton, PhD FRCOphth principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trichiasis surgery and Epilation in people with Trachomatous Trichiasis, run by London School of Hygiene and Tropical Medicine at 1 site in Ethiopia.
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 1 inclusion and 2 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 12 Jan 2012. 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 Ethiopia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Trichiasis (time frame: One and two years). 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 NCT00522912, which also lists 3 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 12 Jan 2012.