Hyaluronic Acid Gels for Upper Lid Retraction in Active Stage Thyroid Eye Disease

Conditions:Ocular, Endocrine
Therapuetic Areas:Endocrinology, Ophthalmology
Age Range:21 - 65
Start Date:December 2013
End Date:March 2021

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Phase IV Study of Hyaluronic Acid Gels for Upper Lid Retraction in Active Stage Thyroid Eye Disease

Thyroid eye disease (TED) is an autoimmune disease that affects the eye area. The disease
presents with a variety of physical findings, including bulging of the eyes (proptosis),
upper and lower eyelid retraction, and swelling/inflammation of the eye itself.

The disease passes through two phases: active and inactive. The active phase lasts between 18
and 24 months. During this phase, TED signs and symptoms generally worsen and then often
improve. The inactive phase follows, during which the signs and symptoms of TED cease to
improve and usually stabilize.

Lid retraction is a cardinal sign of TED. In addition to potentially causing cornea damage
due to improper lid closure, lid retraction is also very troublesome for patients due to its
cosmetic appearance. The precise pathophysiology of lid retraction is poorly understood, but
a leading hypothesis is that it occurs due to scarring and fibrosis in the muscles that lift
the eyelid.

Currently, the definitive treatment for lid retraction is surgery, which can be used to
lengthen the lid itself or remove inflamed tissue from behind the eye, thus causing the eye
to bulge less. In cases when patients first present to their physician with corneal
ulceration or compression of the optic nerve, surgery may be performed immediately. However,
in most instances, surgical procedures are delayed until the active stage of the disease has
passed. Thus, most patients must endure the cosmetic and irritant symptoms of TED for up to
two years.

Hyaluronic Acid Gels (HAG) have been FDA approved for the treatment of facial rhytids
(wrinkles). They are injected under the skin and work by increasing volume. Recently, some
smaller retrospective research studies have shown that HAG is also effective in correcting
upper and lower eyelid retraction in TED. Hence, HAG may be for patients with active stage
TED. It is also thought that if employed early in active phase disease, HAG may also help to
decrease the severity of associated symptoms and reduce the need for surgery.

The purpose of the current investigation is to define the clinical utility of HAG correction
of upper eyelid in active TED in terms of anatomic (lid position), quantitative (corneal dry
eye signs) and qualitative effects (symptom severity and thyroid related quality of life).

Inclusion Criteria:

1. Active stage TO as determined by symptom onset of under 9 months.

2. Upper eyelid retraction of 1mm or greater in one or both eyes.

3. Complaints of either significant ocular symptoms (despite appropriate use of ocular
lubricants), or cosmetic deformity associated with the eyelid retraction.

Exclusion Criteria:

1. Age less than 21 years: due to lack of data on safety for HAG fillers in pediatric

2. Age over 65 years of age: as HAG filler effect may be different in this population

3. Are pregnant or nursing: as there is little safety data on potential teratogenicity of
HAG fillers

4. Have a demonstrated allergy to HAG fillers or lidocaine

5. Have a current infection, skin sore, pimple, rash, hive or cyst over the injection
site: to avoid worsening the infection or transmitting it

6. Have a bleeding disorder or currently taking blood thinning medications such as
Coumadin, heparin or acetylsalicylic acid on a daily basis.
We found this trial at
Los Angeles, California
Los Angeles, CA
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100 Stein Plaza
Los Angeles, California 90095
Principal Investigator: Daniel B Rootman, MD MSc
Phone: 310-206-9727
Los Angeles, CA
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