Hyaluronic Acid Gels for Lower Lid Retraction

Study Overview
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Brief Summary
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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.

Conditions
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Ectropion

Intervention / Treatment
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* Procedure: Hyaluronic acid
* Procedure: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lower eyelid retraction of >1mm in one or both eyes. Complaints of either significant ocular symptoms (OSDI>13) or cosmetic deformity associated with the eyelid retraction. Exclusion Criteria: Age less than 21 years: due to lack of data on safety for HAG fillers in pediatric population Age over 65 years of age: as HAG filler effect may be different in this population Are pregnant or nursing: as there is little safety data on potential teratogenicity of HAG fillers Have a demonstrated allergy to HAG fillers or lidocaine Have a current infection, skin sore, pimple, rash, hive or cyst over the injection site: to avoid worsening the infection or transmitting it Have a bleeding disorder or currently taking blood-thinning medications such as Coumadin or heparin on a daily basis. Currently active stage Thyroid Eye Disease

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyaluronic acid<br>Patients in this arm will receive hyaluronic acid fillers to the lower lid. | Procedure: Hyaluronic acid<br>* Hyaluronic acid filler will be injected in to the lower lid, elevating it to a more anatomic position<br>* Other names: Restylane;|
| Sham Comparator: Saline<br> | Procedure: Saline<br>* Saline will be injected in to the lower lid, elevating it to a more anatomic position<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower eyelid position | Decrease in inferior scleral show | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Objective dry eye signs | Oxford staining score | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ectropion, Hyaluronic Acid, Keratoconjunctivitis Sicca, Lower eyelid retraction