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A Feasibility Study to Develop a Protocol for Functional Lacrimal Magnetic Resonance Imaging

Primary Purpose

Lacrimal Duct Obstruction, Lacrimal Stenosis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
MRI scanning
Sponsored by
Brighton and Sussex University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lacrimal Duct Obstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Lacrimal drainage disease participants (n=5)

    1. Symptomatic epiphora (tearing)
    2. Nasolacrimal drainage dysfunction confirmed by the following characteristics:

      1. An abnormal delay of tear transit on DSG
      2. A normal DCG and lacrimal syringing investigation
      3. Normal eyelid and punctal anatomy

Controls

  1. No epiphora
  2. Normal lacrimal syringing in clinic.

Exclusion criteria

  1. Age under 18
  2. Renal function <30mL/min/1.73m2
  3. Contra-indications to MRI e.g. electronic or metal implants, severe claustrophobia
  4. Known adverse reactions to contrast agents
  5. Pregnancy

Exclusion Criteria:

-

Sites / Locations

  • Brighton & Sussex University Hospitals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

functional lacrimal delay

Arm Description

Participants shown to have functional delay on DSG will be included. The intervention will be an MRI scan during tear drainage

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 4, 2018
Last Updated
March 10, 2022
Sponsor
Brighton and Sussex University Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03411889
Brief Title
A Feasibility Study to Develop a Protocol for Functional Lacrimal Magnetic Resonance Imaging
Official Title
A Study to Develop a Protocol for Functional Magnetic Resonance Imaging of the Lacrimal Drainage System
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 13, 2018 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brighton and Sussex University Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lacrimal Duct Obstruction, Lacrimal Stenosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
functional lacrimal delay
Arm Type
Experimental
Arm Description
Participants shown to have functional delay on DSG will be included. The intervention will be an MRI scan during tear drainage
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI scanning
Other Intervention Name(s)
functional MRI
Intervention Description
MRI scanning during tear drainage
Primary Outcome Measure Information:
Title
A protocol for functional MRI scanning
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Controls No epiphora Normal lacrimal syringing in clinic. Exclusion criteria 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 Exclusion Criteria: -
Facility Information:
Facility Name
Brighton & Sussex University Hospitals
City
Brighton
State/Province
East Sussex
ZIP/Postal Code
BN" 5BE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Feasibility Study to Develop a Protocol for Functional Lacrimal Magnetic Resonance Imaging

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