Hyaluronic Acid Gels for Lower Lid Retraction

Phase 4

Withdrawn

• Conditions: Ectropion
• Interventions: Procedure: Hyaluronic acid; Procedure: Saline

• Registration Number: NCT01838252
• Lead Sponsor: University of California, Los Angeles

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-04-18
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-24
• Primary Completion: 2014-02
• Study Completion: 2014-05
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Lower eyelid retraction of >1mm in one or both eyes.
2. Complaints of either significant ocular symptoms (OSDI>13) or cosmetic deformity associated with the eyelid retraction.

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Exclusion Criteria

1. Age less than 21 years: due to lack of data on safety for HAG fillers in pediatric population
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 or heparin on a daily basis.
7. Currently active stage Thyroid Eye Disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hyaluronic acid	Hyaluronic acid	Patients in this arm will receive hyaluronic acid fillers to the lower lid.
Saline	Saline	-

Primary Outcome Measures

Name	Time	Method
Lower eyelid position	6 weeks	Decrease in inferior scleral show

Secondary Outcome Measures

Name	Time	Method
Subjective dry eye symptoms	6 weeks	Ocular surface disease index score
Objective dry eye signs	6 weeks	Oxford staining score

Trial Locations

Locations (1)

Jules Stein Eye Institute; 🇺🇸 Los Angeles, California, United States