Thyroid Associated Ophthalmopathies
Conditions
Keywords
TED, Prostaglandin Analogues
Brief summary
Prostaglandin analogues eye drops are common and effective treatment for decreasing Intra-Ocular Pressure (IOP) in Glaucoma patients. A number of recently published case reports have documented periorbital fat atrophy following treatment by prostaglandin analogues. In this study the investigators want to use this side-effect of prostaglandin analogues for the treatment of orbital and periocular fat proliferation in inactive Thyroid eye disease (TED) patients, as a conservative substitute for surgical intervention.
Interventions
The patients will receive a single daily drop of bimatoprost for six months.
Sponsors
Rabin Medical Center
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
* Inactive TED (Clinical Activity Score below 3) * Significant exophthalmos or orbital fat expansion.
Exclusion criteria
* Previous prostaglandin analogues treatment due to glaucoma * Known prostaglandin analogues sensitivity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bimatoprost effect on soft tissue amount and exophthalmos in inactive TED patients. | 6 months | To document the effect of bimatoprost treatment on the amount of soft tissue and exophthalmos in inactive TED patients. The following measurements will be performed pre, post and during treatment: orbital ultrasound (measuring the eyebrow fat, retro-orbicularis oculi fat and retrobulbar fat), Hertel exophthalmometry and Marginal Reflex Distance (MRD). The external appearance would be also documented by face picture. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events. | 9 months | Determine the safety of bimatoprost treatment by estimating the probabilities of adverse outcomes. To estimate these probabilities we shall count the number of participants suffering from known side-effects of prostaglandin analogues such as increased eyelash growth and darkening of the periocular skin and iris; as well as any other side-effects observed during treatment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Bimatoprost effect reversibility after treatment cessation. | 3 months | To measure the reversibility of bimatoprost treatment on the amount of soft tissue and exophthalmos at the end of the treatment course and 3 months post cessation. We shall perform the same measurements as described in the Primary Outcome section. |
Countries
Israel
Outcome results
None listed