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

NCT03411889 | Completed

• 1 other identifier: 225255
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Lacrimal Duct Obstruction; Lacrimal Stenosis

Outcome Measures

Primary Outcomes (1)

• 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

  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

Study Arms (1)

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

Diagnostic Test: MRI scanning

Interventions

MRI scanning DIAGNOSTIC_TEST

MRI scanning during tear drainage

Also known as: functional MRI

functional lacrimal delay

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brighton and Sussex University Hospitals NHS Trust: lead

Study Sites (1)

Brighton & Sussex University Hospitals

Brighton, East Sussex, BN" 5BE, United Kingdom

Location

MeSH Terms

Conditions

Lacrimal Duct Obstruction

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 26, 2018
• Study Start: June 13, 2018
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: March 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)