Dry Eye Syndrome Clinical Trial
Official title:
The Effect of Intravenous Glucocorticoids on the Tearfilm in Eyes With Thyroid-associated Ophthalmopathy
Verified date | February 2020 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Thyroid-associated ophthalmopathy (TAO), also called Graves' ophthalmopathy or thyroid eye
disease, is a common orbital disease in adults. Patients with TAO, especially in its active
phase, often complain about symptoms of ocular surface discomfort, including excess tearing,
gritty sensation, increased sensitivity to light and foreign-body sensation, which are
similar to inflammatory ocular surface disorders such as dry-eye syndrome (DES). Incomplete
blink, increased proptosis and greater palpebral fissure width in TAO accelerates tear
evaporation, which increases the tear fluid's osmolarity, and results in ocular surface
damage. The administration of intravenous glucocorticoids can be an effective treatment for
TAO.
The rationale of the present study is to assess the effect of intravenously administered
glucocorticoids on the signs of DES in patients with TAO with new methods such as measurement
of tear film thickness, tear film osmolarity and scattering of the tear film and well
established methods for assessment of the severity of DES. Additionally, impression cytology
and determination of tear cytokines/chemokines will be performed to obtain information about
inflammatory processes on the ocular surface.
Status | Completed |
Enrollment | 18 |
Est. completion date | May 18, 2017 |
Est. primary completion date | May 18, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Men and women aged over 18 years - Active thyroid associated ophthalmopathy with clinical activity score (CAS) of each eye more than 3 or recently experienced worsening of proptosis, lid retraction, or ocular motility disturbance. - Normal ophthalmic findings except symptoms associated with TAO - Scheduled for treatment with systemic glucocorticoids according to the kahaly-scheme Exclusion Criteria: - Chronic inactive TAO - Previous treatment with oral or intravenous glucocorticoids 3 months preceding the study - Participation in a clinical trial in the 3 weeks before the screening visit - Symptoms of a clinically relevant illness in the 3 weeks before the first study day - Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator - Wearing of contact lenses - Intake of dietary supplements in the 3 months preceding the study - Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except topical lubricants - Ocular infection - Ocular surgery in the 3 months preceding the study - Sjögren's syndrome - Stevens-Johnson syndrome - Pregnancy, planned pregnancy or lactating |
Country | Name | City | State |
---|---|---|---|
Austria | Department of Clinical Pharmacology, Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tear film thickness as measured with OCT | Measurements of tear film thickness with OCT will be performed 7 or less days before start of treatment, 6 weeks after start of treatment and 12 weeks after start of treatment | 13 weeks | |
Secondary | Break up time (BUT) | 13 weeks | ||
Secondary | Visual acuity | 13 weeks | ||
Secondary | Tear film osmolarity | 13 weeks | ||
Secondary | Degree of exophthalmia | Hertel exophthalmometry | 13 weeks | |
Secondary | Palpebral fissure width | 13 weeks | ||
Secondary | OSI (Objective Scattering Index) | 13 weeks | ||
Secondary | Tear cytokines/chemokines | 13 weeks | ||
Secondary | Impression cytology | 13 weeks | ||
Secondary | Staining of the cornea with fluorescein | 13 weeks | ||
Secondary | Schirmer I test | 13 weeks | ||
Secondary | Subjective symptoms of dry eye syndrome | 13 weeks |
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