Hyaluronic Acid Gels for Lower Lid Retraction
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|ClinicalTrials.gov Identifier: NCT01838252|
Recruitment Status : Withdrawn
First Posted : April 24, 2013
Last Update Posted : December 3, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Ectropion||Procedure: Hyaluronic acid Procedure: Saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||February 2014|
|Estimated Study Completion Date :||May 2014|
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
- Lower eyelid position [ Time Frame: 6 weeks ]Decrease in inferior scleral show
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838252
|United States, California|
|Jules Stein Eye Institute|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Daniel B Rootman, MD, MSc||University of California, Los Angeles|