An interventional study of MRI scanning in Lacrimal Duct Obstruction and Lacrimal Stenosis, sponsored by Brighton and Sussex University Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-25.
Sponsored by Brighton and Sussex University Hospitals NHS Trust · Not applicable, Interventional, and Diagnostic
Watering eyes (epiphora) is a very common ophthalmic condition. It is frequently caused by dysfunction of the lacrimal (tear) drainage system which is the 'pipework' that takes tears from the eye to the nasal cavity. If the system is completely blocked then the patient is offered surgery to unblock or bypass the obstruction. However, the system is often either partially obstructed, or there is tear drainage delay despite there being no apparent obstruction (functional obstruction). Currently this is investigated with two separate scans, conducted at different times in different departments (CT and nuclear medicine). These are dacryocystography (DCG) and dacryoscintigraphy (DSG) and both are required as they have different limitations and benefits. Moreover DCG is a CT scan that uses radiation.
Functional magnetic resonance dacryocystography (MR DCG) is increasingly widely used in other fields of medicine (e.g. cardiology) because of the increasing acquisition speed and resolution of MRI scanners in recent years. The investigators anticipate functional MRI of the lacrimal drainage system (i.e. scanning as eye drops are instilled and pass down the system) will overcome the shortcomings of DCG and DSG, by simultaneously providing both good anatomical detail and physiological images. Various methods of MR DCG have been described in the literature and there is no standard protocol for this procedure as of current. In this study, the investigators aim to develop a protocol for MR DCG that can be used in routine radiological practice in place of DCG and DSG and get pilot data on tear drainage in participants with known delayed tear drainage and controls with normal tear drainage systems.
Tear drainage delay is a common problem that causes a watery eye. This can impair activities of daily living such as reading and driving, can be a huge nuisance requiring continual dabbing with a tissue and can cause infections and abscesses of the tear drainage system. The current, standard investigations for tear drainage delay have significant limitations with two separate scans in separate departments being required. A functional MRI scan would be able to combine these two scans and provide both better anatomical and functional detail than each one respectively. This would have several major benefits:
Several other functional lacrimal drainage MRI studies have been done. However, a clear protocol has not been developed and there is no data on normal and abnormal MRI appearances and tear transit times.
The normal standard of care will not be delayed by this investigation as it will be conducted while patients are awaiting other lacrimal investigations (DCG and DSG) or lacrimal surgery, none of which would be affected by this study.
Inclusion Criteria:
Lacrimal drainage disease participants (n=5)
Nasolacrimal drainage dysfunction confirmed by the following characteristics:
Controls
Exclusion criteria
Exclusion Criteria:
-
Participants shown to have functional delay on DSG will be included. The intervention will be an MRI scan during tear drainage
Diagnostic Test: MRI scanning
MRI scanning during tear drainage
Also known as: functional MRI
A protocol for functional MRI scanning
This is a feasibility study for functional MRI scanning. The primary outcome is a MRI scanning protocol that can be routinely used to assess the 'real-time' drainage of lacrimal flow
Time frame: 60 minutes. This is a feasibility study in which participants are seen on one occasion and have one MRI scan which is expected to take around 60 minutes
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Brighton and Sussex University Hospitals NHS Trust