Clinical Trial: Hyaluronic Acid Gels for Lower Lid Retraction

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title:

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 Summary:
Sponsor: University of California, Los Angeles

Current Primary Outcome: Lower eyelid position [ Time Frame: 6 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Subjective dry eye symptoms [ Time Frame: 6 weeks ]
  Ocular surface disease index score
• Objective dry eye signs [ Time Frame: 6 weeks ]
  NEI dry eye score
• Objective dry eye signs [ Time Frame: 6 weeks ]
  Oxford staining score

Original Secondary Outcome: Same as current

Information By: University of California, Los Angeles

Dates:
Date Received: April 18, 2013
Date Started: February 2013
Date Completion: May 2014
Last Updated: December 2, 2014
Last Verified: December 2014