Optical Coherence Tomography of Ocular Structures in Epiphora and Dry Eye Syndrome.

Dry Eye Syndrome Clinical Trial

— OCT  

Official title:

Optical Coherence Tomography of Ocular Structures in Epiphora and Dry Eye Syndrome (OCT)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02849093
• Other study ID #: 473/2015/387
• Status: Active, not recruiting
• Phase: N/A
• First received: June 17, 2016
• Last updated: July 26, 2016
• Start date: June 2016
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• Source: Bedford Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Epiphora
• Keratoconjunctivitis Sicca
• Lacrimal Apparatus Diseases
• Sjogren's Syndrome
• Sjögren's Syndrome
• Syndrome

Intervention

Other:
• Non-invasive OCT imaging
Optical Coherence Tomography (OCT) to capture high resolution cross-sectional images of tissue microstructures using infra-red radiation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bedford Hospital NHS Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative difference in OCT appearance of lacrimal and buccal glands measured at a single time-point, between dry eye patients and asymptomatic patients	OCT images of the lacrimal gland and buccal mucosa will be taken from dry eye patients and asymptomatic patients. These images will be compared qualitatively, to determine if there are any differences in the appearance of the lacrimal and buccal glands under OCT, in patients with dry eye disease compared to healthy subjects.	Baseline, at the time of listing for surgery	No
Primary	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	All patients with epiphora who are due to undergo punctoplasty (for punctual stenosis) or conjunctivoplasty (for conjunctivochalasis) will have pre- and post-operative imaging of their left and right lower punctum / conjunctiva respectively. Patients will also have their epiphora symptoms graded according to the Lac Q questionnaire before and after surgery. Asymptomatic patients will have OCT imaging taken of the cornea and conjunctiva.	26 weeks	No