Glaucoma, Ocular Hypertension, Thyroid Eye Disease
Conditions
Keywords
Thyroid Eye Disease, Graves' Disease, Prostaglandin Analogues
Brief summary
The purpose of this study is to evaluate the potential secondary beneficial effect of prostaglandin analogues (PA) treatment in thyroid eye disease (TED) patients. This study aims to determine if PA would change the course of the orbitopathy in TED patients by altering the progression of the common features of TED, including fatty hypertrophy, proptosis, eyelid retraction and optic nerve compression. The eyes with thyroid eye disease and elevated intraocular pressure will be randomised to the PA treatment and the other eye will serve as a control eye and will be treated with Timolol.
Interventions
DRUGProstaglandin Analog
The first choice drug from group of Prostaglandin Analogues will be bimatoprost, if patient will suffer from any side effect of this drug another drug from this group will be administer. If patient turned out to cannot tolerate the prostaglandin analog therapy then the exclusion criteria will be met.
DRUGTimolol
Timolol topical eye drop will be administered in Prostaglandin Analog vs Timolol arm only, in patients with elevated intraocular pressure in both eyes.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* mild or moderate to severe thyroid eye disease in one or both eyes * age \> 18 years * informed consent * intraocular pressure \> 21 mmHg or glaucoma suspect or glaucoma diagnosed in one or both eyes * not on current prostaglandin analog intraocular pressure lowering therapy
Exclusion criteria
* sight threatening thyroid eye disease * children \< 18 years old * patients that are not compliant with treatment or follow-up * patients already on prostaglandin analog treatment * patients that undergo cosmetic periocular procedures during the study will be excluded from further follow up * patients that cannot tolerate prostaglandin analog treatment. * patients with bilateral thyroid eye disease and elevated intraocular pressures that cannot tolerate treatment with timolol or an alternative intraocular pressure lowering medication such as trusopt, combigan, cosopt.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in appearance of facial periorbital region at 6 months. | Baseline and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Hertel exophthalmometry at 3, 6, 9 and 12 months. | Baseline and 3, 6, 9 and 12 months |
| Change from baseline in intraocular pressure at 3, 6, 9 and 12 months. | Baseline and 3, 6, 9 and 12 months |
| Change from baseline in appearance of facial periorbital region at 3, 6, 9 and 12 months. | Baseline and 3, 6, 9 and 12 months |
Countries
United States
Outcome results
None listed