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Lid retraction is a difficult problem encountered in oculofacial plastic surgery. It can result from previous surgery, radiotherapy or cicatrizing disease or it may be idiopathic. Whatever the aetiology, the cosmetic appearance is troublesome to patients and, can be damaging to the cornea. The definitive therapy for lid retraction is surgical, and often involves complicated procedures including tissue grafting.
Hyaluronic acid gels (HAG) have been FDA approved for the treatment of facial rhytids by subcutaneous injection and volume addition. These gels have gained wide popularity in for cosmetic applications in filling volume deficit areas. Functional applications in the periorbital area have also been described including the filling of volume deficit anophthalmic orbits, ectropion and loagophthalmos. Additionally, pilot studies have found HAG to be useful in correcting both upper and lower eyelid retraction, with good effect.
The purpose of this investigation is to define the clinical utility of HAG correction of lower eyelid retraction in terms of anatomic (lid position), quantitative (dry eye signs on cornea) and qualitative effects (symptom severity).
Our hypothesis is that HAG correction of lower eyelid retraction will improve patient comfort, clinical signs of dry eye and aesthetic self image.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic acid | Experimental | Patients in this arm will receive hyaluronic acid fillers to the lower lid. |
|
| Saline | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic acid | Procedure | Hyaluronic acid filler will be injected in to the lower lid, elevating it to a more anatomic position |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lower eyelid position | Decrease in inferior scleral show | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective dry eye symptoms | Ocular surface disease index score | 6 weeks |
| Objective dry eye signs | NEI dry eye score | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel B Rootman, MD, MSc | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jules Stein Eye Institute | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D004483 | Ectropion |
| D007638 | Keratoconjunctivitis Sicca |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| C445361 | Restylane |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D002712 | Chlorides |
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| Saline | Procedure | Saline will be injected in to the lower lid, elevating it to a more anatomic position |
|
| Objective dry eye signs | Oxford staining score | 6 weeks |
| D003229 |
| Conjunctival Diseases |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D006851 |
| Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |