Evaluation of the Efficacy of Restylane Silk in the Correction of Tear Trough Deformity

Inclusion criteria

• Is a healthy male or female between 21 and 65 years old
• Tear trough deformity, Hirmand Type-1 and Type-2
• Is voluntarily willing to consent to participate in the study
• Is willing to comply with all requirements of the study including being photographed, follow post treatment care instructions, to attend all treatment, and follow up visits
• Willingness to waive rights to use of still photos of themselves for research, marketing, or promotional reasons, including on the internet and on social media outlets.
• Willingness to refrain from other surgical, laser, or injectable treatments in the periorbital region during the entire duration of the study.
• Ability to provide informed consent.

Exclusion criteria

• Marked delineation of the inferior orbital rim in the lateral aspect of the eyelid/orbit
• Use of botulinum toxin in the periorbital region within the past 6 months.
• Treatment with injectable fillers in the midface or periorbital region within the past 2 years or treatment at any time in the past with a permanent filler in the midface or periorbital region such as silicone, or PMMA (Artefill)
• Laser skin resurfacing of the periorbital region within the past one year.
• History of lower eyelid blepharoplasty or periorbital surgery in tear trough region.
• The subject has a coagulation disorder or is currently using anti-coagulation medication
• History of facial nerve palsy.
• Inability to discontinue the use of nonsteroidal anti-inflammatory drugs or anticoagulants prior to treatment.
• Current participation in another active clinical trial protocol
• Presence of malar festoons
• Active cutaneous infections
• Allergy or sensitivity to benzocaine, lidocaine, prilocaine, or tetracaine.
• Pregnant or nursing females
• Other factors as deemed by the Principal Investigator that would make a subject unqualified for participation.
• The subject has a history of keloids or compromised wound healing
• The subject has a known adverse reaction to previous injection with hyaluronic acid or other subcutaneously injected device