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

NCT02849093 | Unknown

• 1 other identifier: 473/2015/387
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dry Eye Syndrome; Epiphora; Sjögren's Syndrome

Keywords

Optical coherence tomography; imaging of ocular structures

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Dry Eye Syndrome Patients

Patients who have been diagnosed clinically with Sjögren's will have an OCT image of their lacrimal glands and buccal mucosa taken. Imaging from patients found to have Sjögren's clinically diagnosed following examination of buccal mucosa under the microscope will be compared with images from patients without dry eye syndrome to see of any obvious differences can be identified.

Other: Non-invasive OCT imaging

Epiphora Patients

Pre and post-operative OCT images of patients undergoing punctoplasty or conjunctivoplasty will be compared to images of the same structures in people without watery eyes.

Other: Non-invasive OCT imaging

Asymptomatic Patients

OCT images will be captured of the cornea, conjunctiva, lacrimal gland and buccal mucosa to establish normal appearance in asymptomatic patients.

Other: Non-invasive OCT imaging

Interventions

Non-invasive OCT imaging OTHER

Optical Coherence Tomography (OCT) to capture high resolution cross-sectional images of tissue microstructures using infra-red radiation.

Asymptomatic Patients; Dry Eye Syndrome Patients; Epiphora Patients

Eligibility Criteria

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

Study Population

Ophthalmology Patients (dry eye syndrome \& epiphora), Inflammatory and Immune System Patients, asymptomatic subjects

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bedford Hospital NHS Trust: lead

MeSH Terms

Conditions

Dry Eye Syndromes; Lacrimal Apparatus Diseases; Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Eye Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Anant Sharma, FRCOphth

  Moorfields at Bedford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: July 29, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 29, 2016

Record last verified: 2016-07