Trachomatous TrichiasisPhase 4NCT00522860
A Trial of Non-absorbable Versus Absorbable Sutures for Trichiasis Surgery
A Phase 4 study testing Trichiasis surgery with absorbable sutures and Trichiasis surgery with non-absorbable sutures in people with Trachomatous Trichiasis and Trachoma, 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 in-turning of the eyelids / lashes (trichiasis), leading to corneal damage and blindness. The WHO recommends corrective eyelid surgery for trichiasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trachomatous Trichiasis, Trachoma
- What is being tested?
- Trichiasis surgery with absorbable sutures and Trichiasis surgery with non-absorbable sutures
- 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
- Phase 4
- 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
- Major trichiasis: more than 5 lashes touching the eye
Who cannot join
- Previous eyelid surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial of Non-absorbable (Silk) Sutures Verses Absorbable (Vicryl) Sutures During the Surgical Treatment of Trachomatous Trichiasis
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.
Read the detailed description
Primary outcome measure:
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.
Justification of primary outcome:
The aim of surgery is a permanent solution for trichiasis. If a patient has eyelashes touching the eyeball or there is clinical evidence that they are epilating to prevent this or they have required repeat trichiasis surgery, surgery can be deemed a failure.
Analysis of primary outcome measure
Intention to treat analysis of risk factors for recurrence.
Primary analysis of primary outcome:
It is expected that the important baseline characteristics (those that are known to affect the risk of recurrence) will be balanced between the two arms by stratified (for operating surgeon) randomisation. If this is found to be the case, the outcome of the surgery in the two arms will be compared in an unadjusted logistic regression model for recurrent trichiasis at one year. If the arms are found to be substantially imbalanced with respect to, pre-operative severity, gender or age, an appropriately adjusted logistic regression model will be used.
Individuals will be considered to be recurrent trichiasis cases if they have developed recurrent trichiasis at anytime during the one year follow-up period.
Secondary analysis of primary outcome:
- Effect modification We will assess effect modification of the intervention on recurrence at one year with the following factors by including an interaction term with treatment arm in the logistic regression model.
- Operating surgeon
- Pre-operative severity
- Sex
- Age group
- Conjunctival (papillary) inflammation
- Surgical complications
- Analysis of risk factors for recurrence: A multivariate logistic regression model will be used to identify potential explanatory factors for recurrent trichiasis at one year, in addition to the randomised suture type allocation. Other factors which will be examined in a model of recurrent trichiasis will include
- pre-operative disease severity
- trichiasis
- entropion
- corneal opacity
- surgeon
- infection status at baseline and follow up timepoints
- inflammation status at baseline and follow up timepoints
- whether epilation is being practised
- sex
- age
- geographic location of patient's home
- literacy
- body mass index
- eye dryness
- symptoms
- signs
- Impact of intervention on time-to-first-recurrence. Kaplan-Meier analysis will be used to plot the survival curves for both treatment arms up to the final visit at 2 years. Cox regression will be used to assess the impact of the intervention on time to first recurrence. The hazard ratio will be estimated with Cox regression, adjusting for substantial baseline imbalances if appropriate.
- Recurrence at two years Intention-to-treat analysis will be used to assess the impact of the intervention on failure at 2 years. Failure will be 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 either one year and/or two year follow-up visits.
Secondary outcome measures
- Lashes touching the eyeball The effect of the intervention on the number of lashes touching at one, and two years, respectively, will be analysed using zero inflated Poisson regression (i.e. treating number of lashes as a continuous variable)
- Entropion grade The effect of the intervention on the degree of entropion will be analysed by ordered logistic regression
- Conjunctivilisation of the lid margin grade The effect of the intervention on the degree of conjunctivilisation will be analysed by ordered logistic regression
- Clinical evidence of epilation The effect of the intervention on clinical evidence of epilation will be assessed at one and two years respectively with logistic regression. In addition, Cox regression will be used to analyse time-to-first evidence of epilation.
- Repeat surgery The effect of the intervention on the proportion with repeat surgery will be assessed at one and two years respectively with logistic regression. In addition, Cox regression will be used to analyse time-to-first evidence of first repeat surgery.
- Recurrence (lashes touching the eyeball, clinical evidence of epilation, repeat surgery) + history of epilation A secondary definition of recurrence will incorporate self-reported history of epilation. The primary analyses will be repeated with this definition of recurrence.
- Corneal opacification (CO) (categorical variable)
- Descriptive measures of the baseline severity of CO
- Description of the change in CO between baseline and one and two year follow up time-points.
- Ordered logistic regression analysis for factors associated with change in CO at one year and two years, respectively, including to identify factors associated with it, such as suture type and inflammation.
- Visual acuity (VA) (categorical variable) The effect of the intervention on the visual acuity (logMAR score) at 12 and 24 months will be analysed by linear regression.
- Surgical complications Surgical complications other than recurrence, such as granuloma, incomplete lid closure, inflammation (secondary to either of the two sutures materials) and infection can occur. Descriptive statistics, with significance testing will be used to compare the rates of occurrence of all complications and individual complications at any time during the study period between the two arms of the study.
- Patient satisfaction
Patients are asked the following questions on the follow up questionnaires that indicate their satisfaction with the procedure:
- Do you think your vision is worse, the same or better than before your surgery?
- Do you have eye pain?
- If you have eye pain is it worse, the same or better than before the operation?
- Do your eyes water?
- Did you find the surgery painful?
- If the eyelashes have returned or will return would you seek further surgery?
The proportion answering 'yes' to each of these questions will be compared between the two arms of the trial.
Additionally the answers to questions (b) and (d) will be compared between baseline (pre-operative) and the answer given at each time point within each arm.
- Conditions
- Trachomatous Trichiasis, Trachoma
- Being tested
- Trichiasis surgery with absorbable sutures, Trichiasis surgery with non-absorbable sutures
- Keywords
- Trichiasis, Trachoma, Surgery, Suture, 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 surgery with absorbable suturesProcedure or surgery
Posterior lamellar tarsal rotation. Vicryl sutures, 5/0, 3/8 curved needle, cutting. Three everting sutures.
Trichiasis surgery with non-absorbable suturesProcedure or surgery
Posterior lamellar tarsal rotation. Silk sutures. 4/0. 3/8 curved cutting needle. Three sets of everting sutures.
| Study group | Role | What they receive |
|---|---|---|
| Vicryl Suture | Experimental | Vicryl sutures, 5/0, 3/8 curved cutting needle Receives: Procedure: Trichiasis surgery with absorbable sutures |
| Silk Suture | Active comparator | Silk suture, 4/0, 3/8 curved cutting needle Receives: Procedure: Trichiasis surgery with non-absorbable sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One and two years
Secondary outcomes (5)
Entropion
Measured: One and two years
Corneal opacity
Measured: One and two years
Visual Acuity Change
Measured: One and Two years
Conjunctivilisation of the lid margin grade
Measured: One and two years
Repeat Trichiasis Surgery
Measured: At any time during two years followup.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, 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
- NCT00522860
- Sponsor's protocol ID
- 5025
- 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. 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.
PubMed 22180732Gower 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 Non-absorbable (Silk) Sutures Verses Absorbable (Vicryl) Sutures During the Surgical Treatment of Trachomatous Trichiasis
- ClinicalTrials.gov ID
- NCT00522860
- Acronym / sponsor ID
- 5025
- Conditions
- Trachomatous Trichiasis, Trachoma
- Keywords
- Trichiasis, Trachoma, Surgery, Suture, Ethiopia
- Phase
- Phase 4
- 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 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.
Detailed description
Primary outcome measure:
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.
Justification of primary outcome:
The aim of surgery is a permanent solution for trichiasis. If a patient has eyelashes touching the eyeball or there is clinical evidence that they are epilating to prevent this or they have required repeat trichiasis surgery, surgery can be deemed a failure.
Analysis of primary outcome measure
Intention to treat analysis of risk factors for recurrence.
Primary analysis of primary outcome:
It is expected that the important baseline characteristics (those that are known to affect the risk of recurrence) will be balanced between the two arms by stratified (for operating surgeon) randomisation. If this is found to be the case, the outcome of the surgery in the two arms will be compared in an unadjusted logistic regression model for recurrent trichiasis at one year. If the arms are found to be substantially imbalanced with respect to, pre-operative severity, gender or age, an appropriately adjusted logistic regression model will be used.
Individuals will be considered to be recurrent trichiasis cases if they have developed recurrent trichiasis at anytime during the one year follow-up period.
Secondary analysis of primary outcome:
- Effect modification We will assess effect modification of the intervention on recurrence at one year with the following factors by including an interaction term with treatment arm in the logistic regression model.
- Operating surgeon
- Pre-operative severity
- Sex
- Age group
- Conjunctival (papillary) inflammation
- Surgical complications
- Analysis of risk factors for recurrence: A multivariate logistic regression model will be used to identify potential explanatory factors for recurrent trichiasis at one year, in addition to the randomised suture type allocation. Other factors which will be examined in a model of recurrent trichiasis will include
- pre-operative disease severity
- trichiasis
- entropion
- corneal opacity
- surgeon
- infection status at baseline and follow up timepoints
- inflammation status at baseline and follow up timepoints
- whether epilation is being practised
- sex
- age
- geographic location of patient's home
- literacy
- body mass index
- eye dryness
- symptoms
- signs
- Impact of intervention on time-to-first-recurrence. Kaplan-Meier analysis will be used to plot the survival curves for both treatment arms up to the final visit at 2 years. Cox regression will be used to assess the impact of the intervention on time to first recurrence. The hazard ratio will be estimated with Cox regression, adjusting for substantial baseline imbalances if appropriate.
- Recurrence at two years Intention-to-treat analysis will be used to assess the impact of the intervention on failure at 2 years. Failure will be 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 either one year and/or two year follow-up visits.
Secondary outcome measures
- Lashes touching the eyeball The effect of the intervention on the number of lashes touching at one, and two years, respectively, will be analysed using zero inflated Poisson regression (i.e. treating number of lashes as a continuous variable)
- Entropion grade The effect of the intervention on the degree of entropion will be analysed by ordered logistic regression
- Conjunctivilisation of the lid margin grade The effect of the intervention on the degree of conjunctivilisation will be analysed by ordered logistic regression
- Clinical evidence of epilation The effect of the intervention on clinical evidence of epilation will be assessed at one and two years respectively with logistic regression. In addition, Cox regression will be used to analyse time-to-first evidence of epilation.
- Repeat surgery The effect of the intervention on the proportion with repeat surgery will be assessed at one and two years respectively with logistic regression. In addition, Cox regression will be used to analyse time-to-first evidence of first repeat surgery.
- Recurrence (lashes touching the eyeball, clinical evidence of epilation, repeat surgery) + history of epilation A secondary definition of recurrence will incorporate self-reported history of epilation. The primary analyses will be repeated with this definition of recurrence.
- Corneal opacification (CO) (categorical variable)
- Descriptive measures of the baseline severity of CO
- Description of the change in CO between baseline and one and two year follow up time-points.
- Ordered logistic regression analysis for factors associated with change in CO at one year and two years, respectively, including to identify factors associated with it, such as suture type and inflammation.
- Visual acuity (VA) (categorical variable) The effect of the intervention on the visual acuity (logMAR score) at 12 and 24 months will be analysed by linear regression.
- Surgical complications Surgical complications other than recurrence, such as granuloma, incomplete lid closure, inflammation (secondary to either of the two sutures materials) and infection can occur. Descriptive statistics, with significance testing will be used to compare the rates of occurrence of all complications and individual complications at any time during the study period between the two arms of the study.
- Patient satisfaction
Patients are asked the following questions on the follow up questionnaires that indicate their satisfaction with the procedure:
- Do you think your vision is worse, the same or better than before your surgery?
- Do you have eye pain?
- If you have eye pain is it worse, the same or better than before the operation?
- Do your eyes water?
- Did you find the surgery painful?
- If the eyelashes have returned or will return would you seek further surgery?
The proportion answering 'yes' to each of these questions will be compared between the two arms of the trial.
Additionally the answers to questions (b) and (d) will be compared between baseline (pre-operative) and the answer given at each time point within each arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vicryl Suture | Experimental | Procedure: Trichiasis surgery with absorbable suturesVicryl sutures, 5/0, 3/8 curved cutting needle |
| Silk Suture | Active comparator | Procedure: Trichiasis surgery with non-absorbable suturesSilk suture, 4/0, 3/8 curved cutting needle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Major trichiasis: more than 5 lashes touching the eye
Key exclusion criteria (1 listed)
- Previous eyelid 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 surgery with absorbable suturesPosterior lamellar tarsal rotation. Vicryl sutures, 5/0, 3/8 curved needle, cutting. Three everting sutures. | Procedure or surgery | Vicryl Suture |
| Trichiasis surgery with non-absorbable suturesPosterior lamellar tarsal rotation. Silk sutures. 4/0. 3/8 curved cutting needle. Three sets of everting sutures. | Procedure or surgery | Silk Suture |
Primary outcome
Recurrent trichiasis
Time frame: One and two years
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.
5 secondary outcomes
Entropion
Time frame: One and two years
Corneal opacity
Time frame: One and two years
Visual Acuity Change
Time frame: One and Two years
Conjunctivilisation of the lid margin grade
Time frame: One and two years
Repeat Trichiasis Surgery
Time frame: At any time during two years followup.
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 22180732Rajak 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.
- 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.
- Results paperLink 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 Phase 4 study testing Trichiasis surgery with absorbable sutures and Trichiasis surgery with non-absorbable sutures in people with Trachomatous Trichiasis and Trachoma, 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 1 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Recurrent 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 NCT00522860, 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.