Clinical trial NCT02849093: Optical Coherence Tomography of Ocular Structures in Epiphora and Dry Eye Syndrome.
Official title: Optical Coherence Tomography of Ocular Structures in Epiphora and Dry Eye Syndrome (OCT)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dry Eye Syndrome
Epiphora
Sjögren's Syndrome
Keywords: Optical coherence tomography
imaging of ocular structures
Lead sponsor: Bedford Hospital NHS Trust
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ophthalmology Patients (dry eye syndrome \& epiphora), Inflammatory and Immune System Patients, asymptomatic subjects

Brief summary: The primary aim of the study is to investigate whether optical coherence tomography (OCT) may be a useful tool for investigating the in-vivo histology of ocular structures in patients with tear film pathology. In epiphora the investigators will image the proximal lacrimal system. In dry eye syndrome the investigators will image the lacrimal gland and also the buccal mucosa.

The secondary aim of the study is to investigate the appearance of the normal cornea and conjunctiva under OCT imaging.

Detailed description: Optical Coherence Tomography (OCT) is a safe and non-invasive method of high resolution cross-sectional imaging of tissue microstructures using infra-red radiation. It was first described by Huang et al in 1991.

The principle of OCT imaging is similar to ultrasound; infra-red light is shone at a tissue of interest and the reflectivity of each layer within the tissue gives rise to a signal that enables a cross-sectional picture of the tissue to be constructed. In contrast to ultrasound however, it is not possible to use the timing of reflected pulses of light to infer the distance of the reflecting surface. This is because of the extremely high velocity of light (3x10\^8 ms\^-1), which would require the detector to have a temporal resolution of a few tens of femtoseconds in order to provide a spatial resolution of 10 microns within the tissue under observation. therefore, interferometry is applied to the infra-red light source in order to determine the distance that reflected light has travelled.

OCT currently has a wide range of applications including imaging the retina, the anterior chamber of the eye and the endothelium of the coronary arteries (when used intravascularly). It has also been used in preclinical cancer research to image tumours. IT has a resolution of 1-20µm and can penetrate approximately 1-2mm into tissue.

Dry Eye Syndrome:

Sjögren's is a common cause of dry eye syndrome. Currently a biopsy of the lacrimal gland is required to establish the diagnosis. In this study the investigators explore whether it is possible to distinguish the lacrimal gland in Sjögren's patients from the normal lacrimal gland using OCT imaging. The investigators will also image the buccal mucosa of suspected Sjögren's patients and compare the results to previously published images of the normal mucosa.

Epiphora:

Punctal anatomy is clinically relevant in the management of epiphora because punctal stenosis is one of the many causes of this condition. However, there are currently no routinely used imaging modalities or objective quantitative assessment systems for the proximal lacrimal system.

OCT seems to be ideally suited to imaging the punctum due to its high resolution and non-invasive nature. The investigators have recently completed a study demonstrating the feasibility of OCT imaging of the proximal lacrimal system in a cohort of subjects with normal ocular anatomy and no symptoms of epiphora. In this study the investigators will examine the practical clinical applications of OCT imaging pre and post-operatively in patients undergoing punctoplasty or conjunctivoplasty to treat epiphora.

Asymptomatic Patients:

The investigators aim to establish the normal OCT appearance of the conjunctiva and cornea; and also aim to establish the normal appearance of the lacrimal gland and the buccal mucosa.

Eligibility criteria: Inclusion Criteria:

* Patients with watery eyes who are listed for punctoplasty surgery
* Patients with dry eyes secondary to Sjögren's (i.e. presence of anti-Ro/SSA or La/SSB autoantibodies, reduced Schirmer's test less than 5mm over 5 minutes without local anaesthesia or typical clinical presentation).
* Members of staff at our eye clinic with no history of previous ocular surgery or watering/dryness.

Exclusion Criteria:

* Previous eyelid or lacrimal surgery
* Patients without capacity to consent
* Patients unwilling to participate
* Age under 18

Primary outcomes:
measure: Qualitative difference in OCT appearance of lacrimal and buccal glands measured at a single time-point, between dry eye patients and asymptomatic patients
timeFrame: Baseline, at the time of listing for surgery
measure: Comparison of punctual diameter, canalicular diameter and canalicular depth between asymptomatic patients and patients with epiphora pre-operatively and post-operatively, and correlation with Lac-Q questionnaire score
timeFrame: 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Moorfields at Bedford
name: Anant Sharma, FRCOphth
role: PRINCIPAL_INVESTIGATOR
References: