Lacrimal Duct ObstructionNCT03411889
A Feasibility Study to Develop a Protocol for Functional Lacrimal Magnetic Resonance Imaging
A study testing MRI scanning in people with Lacrimal Duct Obstruction and Lacrimal Stenosis, run by Brighton and Sussex University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lacrimal Duct Obstruction, Lacrimal Stenosis
- What is being tested?
- MRI scanning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jun 2018to 31 Mar 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Lacrimal drainage disease participants (n=5)
- Symptomatic epiphora (tearing)
- Nasolacrimal drainage dysfunction confirmed by the following characteristics:
- An abnormal delay of tear transit on DSG
- A normal DCG and lacrimal syringing investigation
- Normal eyelid and punctal anatomy
Show all 9Show fewer
- Controls
- No epiphora
- Normal lacrimal syringing in clinic.
Who cannot join
- Age under 18
- Renal function <30mL/min/1.73m2
- Contra-indications to MRI e.g. electronic or metal implants, severe claustrophobia
- Known adverse reactions to contrast agents
- Pregnancy
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brighton & Sussex University Hospitals
Brighton, East Sussex, BN" 5BE
About this study
Official title: A Study to Develop a Protocol for Functional Magnetic Resonance Imaging of the Lacrimal Drainage System
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.
Read the detailed description
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:
- Improved diagnostic information to guide the treatment choice
- Reduced scan resource usage as one scan would provide all the required functional anatomical and functional information.
- Improved patient convenience
- Improved safety as radiation is used for CT DCG, where MRI The study involves investigation of both controls with normal tear drainage and individuals with known tear drainage delay. Both groups are required for the development of the protocol as the speed of tear transit will differ greatly which will facilitate optimisation of the MRI scan protocol. This will also provide preliminary data on the speed of tear passage in a normal lacrimal drainage system and in an impaired system.
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.
- Conditions
- Lacrimal Duct Obstruction, Lacrimal Stenosis
- Being tested
- MRI scanning
- Medical subject headings
- Lacrimal Duct Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanningDiagnostic test
Also called functional MRI
MRI scanning during tear drainage
| Study group | Role | What they receive |
|---|---|---|
| functional lacrimal delay | Experimental | Participants shown to have functional delay on DSG will be included. The intervention will be an MRI scan during tear drainage Receives: Diagnostic Test: MRI scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start13 Jun 2018
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lacrimal Duct ObstructionStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brighton and Sussex University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411889
- Sponsor's protocol ID
- 225255
- Status last verified
- Mar 2022
- First submitted
- 4 Jan 2018
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Develop a Protocol for Functional Magnetic Resonance Imaging of the Lacrimal Drainage System
- ClinicalTrials.gov ID
- NCT03411889
- Acronym / sponsor ID
- 225255
- Conditions
- Lacrimal Duct Obstruction, Lacrimal Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Brighton and Sussex University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 26 Jan 2018 (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.
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.
Detailed description
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:
- Improved diagnostic information to guide the treatment choice
- Reduced scan resource usage as one scan would provide all the required functional anatomical and functional information.
- Improved patient convenience
- Improved safety as radiation is used for CT DCG, where MRI The study involves investigation of both controls with normal tear drainage and individuals with known tear drainage delay. Both groups are required for the development of the protocol as the speed of tear transit will differ greatly which will facilitate optimisation of the MRI scan protocol. This will also provide preliminary data on the speed of tear passage in a normal lacrimal drainage system and in an impaired system.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| functional lacrimal delay | Experimental | Diagnostic Test: MRI scanningParticipants shown to have functional delay on DSG will be included. The intervention will be an MRI scan during tear drainage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Lacrimal drainage disease participants (n=5)
- Controls
- No epiphora
- Normal lacrimal syringing in clinic.
Key exclusion criteria (6 listed)
- Age under 18
- Renal function <30mL/min/1.73m2
- Contra-indications to MRI e.g. electronic or metal implants, severe claustrophobia
- Known adverse reactions to contrast agents
- Pregnancy
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 |
|---|---|---|
| MRI scanningAlso: functional MRIMRI scanning during tear drainage | Diagnostic test | functional lacrimal delay |
Primary outcome
A protocol for functional MRI scanning
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
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
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 25 Mar 2022.
- Individual participant dataSharing planned: No
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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 study testing MRI scanning in people with Lacrimal Duct Obstruction and Lacrimal Stenosis, run by Brighton and Sussex University Hospitals 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 9 inclusion and 6 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 25 Mar 2022. 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.
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?
A protocol for functional MRI scanning (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2022.