Clinical Trial Details
— Status: Suspended
Administrative data
| NCT number |
NCT04724512 |
| Other study ID # |
18SM4898 |
| Secondary ID |
|
| Status |
Suspended |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
October 25, 2021 |
| Est. completion date |
October 2024 |
Study information
| Verified date |
November 2021 |
| Source |
Imperial College Healthcare NHS Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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).
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.
