EntropionPhase 4SUSYNCT04724512
SUSY Study (SUture StudY) Comparing Scarring With Polypropylene vs Polyglactin 910 Sutures
A Phase 4 study testing suture in people with Entropion and Inflammation in the Eyelid, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
Entropion is a common condition in which the ageing eyelid becomes lax and rolls inwards, resulting in the eyelashes rubbing against the surface of the eye. This can cause discomfort, excessive watering and in severe cases inflammation of the surface of the eye which may lead to permanent scarring and impairment of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Entropion, Inflammation in the Eyelid
- What is being tested?
- suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Oct 2021to Oct 2024
- 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
- Adult patients (aged 18 years or over)
- Diagnosis of involutional entropion with sufficient lid laxity for a wedge excision
- Ability to provide informed consent
Who cannot join
- Aged under 18 years
- Prior lower eyelid surgery
- Predisposing conditions and treatments known to interfere with scarring and healing
- Concurrent steroid treatment
- Addison's disease
- Poorly controlled diabetes
Show all 10Show fewer
- History of keloid scarring
- History or current cicatrizing disease
- Warfarin
- Unable to provide informed consent No one will be unfairly excluded/included in the research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial to Compare Tissue Reactions and Scarring With Polypropylene vs Polyglactin 910 Sutures in Periocular Skin: SUSY Study (SUture StudY)
Entropion is a common condition in which the ageing eyelid becomes lax and rolls inwards, resulting in the eyelashes rubbing against the surface of the eye. This can cause discomfort, excessive watering and in severe cases inflammation of the surface of the eye which may lead to permanent scarring and impairment of vision.
There are several options for surgical management of entropion. One of the quickest and simplest treatments to turn the eyelid outwards is to have three stitches ('everting sutures') placed into the eyelid. However recurrence of the entropion is common following this procedure alone. A more permanent operation ('definitive surgery') is to shorten and tighten the eyelid ('wedge excision') in addition to the everting sutures. One approach is to perform the everting sutures soon after the patient attends, as this procedure can be done in a clinic or minor operations theatre and provides immediate relief of symptoms, followed by the wedge excision at a later date, when a slot is available in the operating theatre (which has a longer waiting list). These procedures are routinely offered to patients at our hospital.
Different surgeons use different types of stitches to turn the eyelid outwards e.g. polypropylene or polyglactin 910. Currently, there is no consensus as to which stitch causes less inflammation in the eyelid. The aim of this research study is to compare the inflammatory reaction between the two types of stitches. If there is a significant difference, this could provide useful information for surgeons in deciding which stitch is more appropriate for patients, especially those prone to scarring. We will assess the outcome of each type of stitch in terms of objective and clinical assessment of any scars (through questionnaires) and amount of inflammation caused (through examination of the tissue in the lab).
Read the detailed description
Purpose and design This study will be the first of its kind to address the difference in inflammatory reaction between these two sutures in entropion repair surgery. Both sutures are widely used in the NHS in eyelid surgery already. The study design has involved peer review from eminent doctors and two statisticians. The questionnaire development involved patients.
Recruitment Patients will be recruited from the oculoplastic clinics at the Western Eye Hospital and Royal Bournemouth Hospital where they will be approached by the principal investigator and colleagues who are also members of the regular care team and GCP trained. Patients will be informed about the study and given sufficient time to decide whether or not they wish to participate. Fully informed consent will be obtained before any study procedures will take place.
INCLUSION CRITERIA
- Adult patients (aged 18 years or over)
- Diagnosis of involutional entropion with sufficient lid laxity for a wedge excision
- Ability to provide informed consent EXCLUSION CRITERIA
- Aged under 18 years
- Prior lower eyelid surgery
- Predisposing conditions and treatments known to interfere with scarring and healing
- Concurrent steroid treatment
- Addison's disease
- Poorly controlled diabetes
- History of keloid scarring
- History or current cicatrizing disease
- Warfarin
- Unable to provide informed consent No one will be unfairly excluded/included in the research
Consent Consent will be taken by a researcher who is able to assess capacity and does so in everyday practice. Only participants who are able to give fully informed consent will be approached for participation.
Risks:
The suture material being studied are widely used in oculoplastic surgery internationally and within the NHS. All sutures can cause scarring, although the risk of significant scarring in eyelid surgery is low as eyelids tend to heal well due to a good blood supply. The main risk of surgery is that the procedure does not work, but these are standard NHS treatments and are accepted as being low risk. Patients will be informed that a benefit of being in the trial is that their procedure will be performed by a senior oculoplastic surgeon and much sooner than is usually possible on a standard NHS waiting list. They will have more close attention paid to their symptoms and a more detailed assessment and aftercare.
Confidentiality The investigators will abide by the Caldicott principles. Confidentiality will be maintained at all times in compliance with the ICH GCP and applicable Trust protocols.
Conflict of Interest There is no financial or other conflicts of interest. This is an investigator-led study. Ethicon are providing funding for the study but they have not been involved in the study design and will have no rights over the data handling or publication.
- Conditions
- Entropion, Inflammation in the Eyelid
- Being tested
- suture
- Medical subject headings
- Entropion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sutureDevice
a type of suture used in entropion surgery
| Study group | Role | What they receive |
|---|---|---|
| polypropylene | Active comparator | patients randomised to receive polypropylene sutures. Receives: Device: suture |
| polyglactin | Active comparator | patients randomised to receive polyglactin sutures. Receives: Device: suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
diameter of the inflammatory reaction around the suture material
The primary outcome measure will be histological, looking at the diameter of the inflammatory reaction around the suture material. In order to minimise the risk of bias from oblique sectioning of the histology, the smallest diameter recorded on each section will be used. Measurements will be taken at 6 levels within the tissue and the mean diameter will be recorded.
Measured: 6 months post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start25 Oct 2021
- Primary completionMay 2024 (estimated)
- Study completionOct 2024 (estimated)
Why it stopped: setup activities were suspended due to COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EntropionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of different types of stitches to turn the eyelid outwards e.g. polypropylene Vs polyglactin 910 to establish if there is a difference in the level of post-operative inflammation.
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724512
- Sponsor's protocol ID
- 18SM4898
- Acronym
- SUSY
- Status last verified
- Nov 2021
- First submitted
- 21 Jan 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fayers T, Vekinis JS, Ah-Kye L, Parham D, Anketell P, Weir J, A'Hern R, Parkin B. Prospective randomised controlled trial to compare tissue reactions and scarring with polypropylene versus polyglactin 910 sutures in periocular skin. Br J Ophthalmol. 2026 Jun 22;110(7):830-835. doi: 10.1136/bjo-2025-327724.
PubMed 41386795
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial to Compare Tissue Reactions and Scarring With Polypropylene vs Polyglactin 910 Sutures in Periocular Skin: SUSY Study (SUture StudY)
- ClinicalTrials.gov ID
- NCT04724512
- Acronym / sponsor ID
- SUSY / 18SM4898
- Conditions
- Entropion, Inflammation in the Eyelid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: setup activities were suspended due to COVID
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 26 Jan 2021 (actual)
- 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.
Entropion is a common condition in which the ageing eyelid becomes lax and rolls inwards, resulting in the eyelashes rubbing against the surface of the eye. This can cause discomfort, excessive watering and in severe cases inflammation of the surface of the eye which may lead to permanent scarring and impairment of vision.
There are several options for surgical management of entropion. One of the quickest and simplest treatments to turn the eyelid outwards is to have three stitches ('everting sutures') placed into the eyelid. However recurrence of the entropion is common following this procedure alone. A more permanent operation ('definitive surgery') is to shorten and tighten the eyelid ('wedge excision') in addition to the everting sutures. One approach is to perform the everting sutures soon after the patient attends, as this procedure can be done in a clinic or minor operations theatre and provides immediate relief of symptoms, followed by the wedge excision at a later date, when a slot is available in the operating theatre (which has a longer waiting list). These procedures are routinely offered to patients at our hospital.
Different surgeons use different types of stitches to turn the eyelid outwards e.g. polypropylene or polyglactin 910. Currently, there is no consensus as to which stitch causes less inflammation in the eyelid. The aim of this research study is to compare the inflammatory reaction between the two types of stitches. If there is a significant difference, this could provide useful information for surgeons in deciding which stitch is more appropriate for patients, especially those prone to scarring. We will assess the outcome of each type of stitch in terms of objective and clinical assessment of any scars (through questionnaires) and amount of inflammation caused (through examination of the tissue in the lab).
Detailed description
Purpose and design This study will be the first of its kind to address the difference in inflammatory reaction between these two sutures in entropion repair surgery. Both sutures are widely used in the NHS in eyelid surgery already. The study design has involved peer review from eminent doctors and two statisticians. The questionnaire development involved patients.
Recruitment Patients will be recruited from the oculoplastic clinics at the Western Eye Hospital and Royal Bournemouth Hospital where they will be approached by the principal investigator and colleagues who are also members of the regular care team and GCP trained. Patients will be informed about the study and given sufficient time to decide whether or not they wish to participate. Fully informed consent will be obtained before any study procedures will take place.
INCLUSION CRITERIA
- Adult patients (aged 18 years or over)
- Diagnosis of involutional entropion with sufficient lid laxity for a wedge excision
- Ability to provide informed consent EXCLUSION CRITERIA
- Aged under 18 years
- Prior lower eyelid surgery
- Predisposing conditions and treatments known to interfere with scarring and healing
- Concurrent steroid treatment
- Addison's disease
- Poorly controlled diabetes
- History of keloid scarring
- History or current cicatrizing disease
- Warfarin
- Unable to provide informed consent No one will be unfairly excluded/included in the research
Consent Consent will be taken by a researcher who is able to assess capacity and does so in everyday practice. Only participants who are able to give fully informed consent will be approached for participation.
Risks:
The suture material being studied are widely used in oculoplastic surgery internationally and within the NHS. All sutures can cause scarring, although the risk of significant scarring in eyelid surgery is low as eyelids tend to heal well due to a good blood supply. The main risk of surgery is that the procedure does not work, but these are standard NHS treatments and are accepted as being low risk. Patients will be informed that a benefit of being in the trial is that their procedure will be performed by a senior oculoplastic surgeon and much sooner than is usually possible on a standard NHS waiting list. They will have more close attention paid to their symptoms and a more detailed assessment and aftercare.
Confidentiality The investigators will abide by the Caldicott principles. Confidentiality will be maintained at all times in compliance with the ICH GCP and applicable Trust protocols.
Conflict of Interest There is no financial or other conflicts of interest. This is an investigator-led study. Ethicon are providing funding for the study but they have not been involved in the study design and will have no rights over the data handling or publication.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison of different types of stitches to turn the eyelid outwards e.g. polypropylene Vs polyglactin 910 to establish if there is a difference in the level of post-operative inflammation.
| Arm | Type | Receives |
|---|---|---|
| polypropylene | Active comparator | Device: suturepatients randomised to receive polypropylene sutures. |
| polyglactin | Active comparator | Device: suturepatients randomised to receive polyglactin sutures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (aged 18 years or over)
- Diagnosis of involutional entropion with sufficient lid laxity for a wedge excision
- Ability to provide informed consent
Key exclusion criteria (10 listed)
- Aged under 18 years
- Prior lower eyelid surgery
- Predisposing conditions and treatments known to interfere with scarring and healing
- Unable to provide informed consent No one will be unfairly excluded/included in the research
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 |
|---|---|---|
| suturea type of suture used in entropion surgery | Device | polyglactin, polypropylene |
Primary outcome
diameter of the inflammatory reaction around the suture material
Time frame: 6 months post operation
The primary outcome measure will be histological, looking at the diameter of the inflammatory reaction around the suture material. In order to minimise the risk of bias from oblique sectioning of the histology, the smallest diameter recorded on each section will be used. Measurements will be taken at 6 levels within the tissue and the mean diameter will be recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Derived from this study: PubMed 41386795Fayers T, Vekinis JS, Ah-Kye L, Parham D, Anketell P, Weir J, A'Hern R, Parkin B. Prospective randomised controlled trial to compare tissue reactions and scarring with polypropylene versus polyglactin 910 sutures in periocular skin. Br J Ophthalmol. 2026 Jun 22;110(7):830-835. doi: 10.1136/bjo-2025-327724.
- Individual participant dataSharing planned: No
Related trials for Entropion
RecruitingObservational study
Development of a Mobile Terminal-Based Intelligent Detection System for Multiple Anterior Segment Diseases of the Eye
Artifical Intelligence, Cataract
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.
The record lists no contact. Use the official record to reach the sponsor.
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 suture in people with Entropion and Inflammation in the Eyelid, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
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 3 inclusion and 10 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: paused, as of the sponsor's last update on 30 Nov 2021. 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 Kingdom. 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?
Results are not available in the source record.
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?
diameter of the inflammatory reaction around the suture material (time frame: 6 months post operation). 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 NCT04724512, which also lists 1 linked publication.
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 30 Nov 2021.