Hyaluronic Acid Gels for Lower Lid Retraction
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
- Lower eyelid position [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Decrease in inferior scleral show
- Subjective dry eye symptoms [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Ocular surface disease index score
- Objective dry eye signs [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]NEI dry eye score
- Objective dry eye signs [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Oxford staining score
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: Hyaluronic acid
Patients in this arm will receive hyaluronic acid fillers to the lower lid.
Procedure: Hyaluronic acid
Hyaluronic acid filler will be injected in to the lower lid, elevating it to a more anatomic position
Other Name: Restylane
|Sham Comparator: Saline||
Saline will be injected in to the lower lid, elevating it to a more anatomic position
Please refer to this study by its ClinicalTrials.gov identifier: NCT01838252
|Contact: Dia Cervantes||(310) email@example.com|
|United States, California|
|Jules Stein Eye Institute||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Dia Cervantes 310-206-9727 firstname.lastname@example.org|
|Principal Investigator: Dan B Rootman, MD, MSc|
|Principal Investigator:||Daniel B Rootman, MD, MSc||University of California, Los Angeles|