Clinical trial NCT01838252: Hyaluronic Acid Gels for Lower Lid Retraction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Ectropion
Keywords: Ectropion
Hyaluronic Acid
Keratoconjunctivitis Sicca
Lower eyelid retraction
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2013-04-24
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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

Primary outcomes:
measure: Lower eyelid position
timeFrame: 6 weeks
Secondary outcomes:
measure: Subjective dry eye symptoms
timeFrame: 6 weeks
measure: Objective dry eye signs
timeFrame: 6 weeks
measure: Objective dry eye signs
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jules Stein Eye Institute
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Daniel B Rootman, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: