Dry Eye Syndrome, Thyroid-associated Ophthalmopathy
Conditions
Keywords
Methylprednisolone, Dry Eye Syndrome, Tear Film, Thyroid-associated ophthalmopathy
Brief summary
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.
Interventions
DRUGMethylprednisolone
500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. infusion once a week for 6 weeks
DRUGEsomeprazole
40mg i.v. infusion once a week for 12 weeks
Sponsors
Medical University of Vienna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear film thickness as measured with OCT | 13 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Break up time (BUT) | 13 weeks | — |
| Visual acuity | 13 weeks | — |
| Degree of exophthalmia | 13 weeks | Hertel exophthalmometry |
| Palpebral fissure width | 13 weeks | — |
| OSI (Objective Scattering Index) | 13 weeks | — |
| Tear film osmolarity | 13 weeks | — |
| Impression cytology | 13 weeks | — |
| Staining of the cornea with fluorescein | 13 weeks | — |
| Schirmer I test | 13 weeks | — |
| Subjective symptoms of dry eye syndrome | 13 weeks | — |
| Tear cytokines/chemokines | 13 weeks | — |
Countries
Austria
Outcome results
None listed