Dry Eye SyndromeOCTNCT02849093
Optical Coherence Tomography of Ocular Structures in Epiphora and Dry Eye Syndrome.
An observational study of Dry Eye Syndrome and Epiphora, run by Bedford Hospital NHS Trust.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndrome, Epiphora, Sjögren's Syndrome
- What is being tested?
- Non-invasive OCT imaging
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ophthalmology Patients (dry eye syndrome \& epiphora), Inflammatory and Immune System Patients, asymptomatic subjects
Who may be able to join
- 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.
Who cannot join
- Previous eyelid or lacrimal surgery
- Patients without capacity to consent
- Patients unwilling to participate
- Age under 18
About this study
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.
Read the 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.
- Conditions
- Dry Eye Syndrome, Epiphora, Sjögren's Syndrome
- Being tested
- Non-invasive OCT imaging
- Keywords
- Optical coherence tomography, imaging of ocular structures
- Medical subject headings
- Dry Eye Syndromes, Lacrimal Apparatus Diseases, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive OCT imagingOther
Optical Coherence Tomography (OCT) to capture high resolution cross-sectional images of tissue microstructures using infra-red radiation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Non-invasive OCT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bedford Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anant Sharma, FRCOphth, Principal investigator, Moorfields at Bedford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849093
- Sponsor's protocol ID
- 473/2015/387
- Acronym
- OCT
- Status last verified
- Jul 2016
- First submitted
- 17 Jun 2016
- Last updated
- 29 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography of Ocular Structures in Epiphora and Dry Eye Syndrome (OCT)
- ClinicalTrials.gov ID
- NCT02849093
- Acronym / sponsor ID
- OCT / 473/2015/387
- Conditions
- Dry Eye Syndrome, Epiphora, Sjögren's Syndrome
- Keywords
- Optical coherence tomography, imaging of ocular structures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bedford Hospital NHS TrustUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dry Eye Syndrome Patients | – | Other: Non-invasive OCT imagingPatients 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. |
| Epiphora Patients | – | Other: Non-invasive OCT imagingPre 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. |
| Asymptomatic Patients | – | Other: Non-invasive OCT imagingOCT images will be captured of the cornea, conjunctiva, lacrimal gland and buccal mucosa to establish normal appearance in asymptomatic patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ophthalmology Patients (dry eye syndrome \& epiphora), Inflammatory and Immune System Patients, asymptomatic subjects
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Previous eyelid or lacrimal surgery
- Patients without capacity to consent
- Patients unwilling to participate
- Age under 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive OCT imagingOptical Coherence Tomography (OCT) to capture high resolution cross-sectional images of tissue microstructures using infra-red radiation. | Other | Asymptomatic Patients, Dry Eye Syndrome Patients, Epiphora Patients |
Primary outcome
Qualitative difference in OCT appearance of lacrimal and buccal glands measured at a single time-point, between dry eye patients and asymptomatic patients
Time frame: Baseline, at the time of listing for surgery
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.
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
Time frame: 26 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anant Sharma, FRCOphth principal investigator
Moorfields at Bedford
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Syndrome and Epiphora, run by Bedford Hospital NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative difference in OCT appearance of lacrimal and buccal glands measured at a single time-point, between dry eye patients and asymptomatic patients (time frame: Baseline, at the time of listing for surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.