Dry Eye Syndrome Clinical Trial
Official title:
Optical Coherence Tomography of Ocular Structures in Epiphora and Dry Eye Syndrome (OCT)
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.
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.
;
Observational Model: Cohort, Time Perspective: Cross-Sectional
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02597803 -
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1
|
Phase 2/Phase 3 | |
| Completed |
NCT02522312 -
A Retrospective Analysis of Restasis® Benefits in Dry Eye Contact Lens Patients
|
N/A | |
| Completed |
NCT01863368 -
Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining
|
N/A | |
| Completed |
NCT01753752 -
Evaluation of the Corneal Residence Time of Chitosan-N-acetylcysteine Eye Drops in Patients With Dry Eye Syndrome After Single and Multiple Instillation
|
Phase 2 | |
| Completed |
NCT01753687 -
Correlation of Different Signs for Assessment of Dry Eye Syndrome
|
N/A | |
| Completed |
NCT01212471 -
A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease
|
Phase 3 | |
| Completed |
NCT01198782 -
Evaluating Safety and Efficacy of FID 112903 Post Discontinuation of Long-term Use of RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%
|
Phase 4 | |
| Completed |
NCT01162954 -
Phase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT00544713 -
Evaluate the Safety and Efficacy of a New Artificial Tear for Use After LASIK Surgery
|
N/A | |
| Completed |
NCT00535054 -
Study to Assess the Safety and Patients' Satisfaction of Tears Again* in the Treatment of Dry Eye Symptoms
|
N/A | |
| Completed |
NCT00344721 -
A Placebo Controlled Double Masked Clinical Assessment Study of Essential Fatty Acid Supplement and Its Effect on Patients With Apparent Aqueous Deficient Dry Eye Syndrome
|
N/A | |
| Completed |
NCT03830359 -
Efficacy, Safety of T2769 in Dry Eye Disease
|
N/A | |
| Completed |
NCT04139122 -
Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease
|
Phase 1/Phase 2 | |
| Completed |
NCT02758327 -
Evaluation of Tear Osmolarity Over Time With Sustained Use of Thera Tears Lubricating Drops
|
Phase 4 | |
| Completed |
NCT01970917 -
Effect of Olixia Pure® Eye Drops on Tear Film Thickness in Healthy Subjects
|
Phase 4 | |
| Completed |
NCT02066051 -
IPL and Meibomian Gland Expression to Treat Ocular Rosacea Ocular GVHD
|
N/A | |
| Completed |
NCT02092207 -
Phase 2 Study to Evaluation the Safety and Efficacy of Orally Administered KL7016 in Patients With Dry Eye Syndrome
|
Phase 2 | |
| Completed |
NCT01541891 -
Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome
|
Phase 2 | |
| Completed |
NCT01252121 -
Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline
|
N/A | |
| Completed |
NCT00765804 -
Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Dry Eye
|
Phase 2 |