Fillers in Ophthalmic Practice

Transcription

1 Allied Ophthalmic Sciences : Ocular Adjuncts Delhi Journal of Ophthalmology Fillers in Ophthalmic Practice Saurabh Kamal MS, DNB, Ruchi Goel MS, DNB, Sonam Angmo Bodh MS, DNB, Sushil Kumar MD Abstract The field of soft tissue augmentation has had a rapid growth over the past several years, mainly due to the development of fillers which are now routinely utilized for rejuvenation of the skin. Understanding the different characteristics, capabilities, risks, and limitations of the available dermal and subdermal fillers can help physicians improve patient outcomes and reduce the risk of complications. The longer lasting, less immunogenic and more convenient hyaluronic acid fillers have now become the gold standard. Del J Ophthalmol 2012;23(1): Key Words : fillers, hyaluronic acid, collagen, autologous fat, wrinkles DOI : Facial Aging The skin comprises three layers: the epidermis, dermis and subcutis. The dermis consists mainly of fibroblasts, which synthesize the components of extracellular matrix. These include collagen, elastin and hyaluronic acid. Hyaluronic acid binds water and creates volume in skin. With aging, the constituents of extracellular matrix degrade resulting in decreased elasticity, increased roughness, and dehydration of the skin. The innermost layer (subcutis) which consists of subcutaneous fat undergoes partial atrophy and redistribution, causing changes in volumetric appearance and symmetry of the face. The hallmark of aging is loss of subcutaneous volume, thinning of dermis, loss of elasticity and underlying atrophy of the natural fat pads. These result in appearance of various lines and folds. Repeated muscle action produces prominent wrinkles and creases in the mimetic areas of facial skin such as the glabella, periorbital skin, nasolabial creases, and perioral skin. Skeletal changes resulting in decreased height of the maxilla and the mandible occur in the later decades of life (6 th 8 th decades) which accentuate the above findings. The four pillars of facial rejuvenation are 1 1) Ensuring adequate skeletal framework and support 2) Tightening and repositioning of the investing musculofascial aponeurotic system of the face and neck (galea, superficial muscular aponeurotic system [SMAS], and platysma) 3) Replacement of soft tissue volume loss 4) Redraping and removal of excess skin This article will focus on replacement of soft tissue volume loss. Dermal fillers and subcutaneous volume enhancers have enjoyed the greatest degree of development and differentiation because they are administered in an officebased setting. Other option for enhancement can be skeletal onlay grafts. Indications of Fillers Filler can restore symmetry and volume and re-create a smooth skin surface. In combination with other treatments such as botulinum toxin, fillers may provide satisfying and prolonged results in following indication :- 1. Upper face Glabellar lines, Eyebrow, Forehead 2. Middle face Tear trough, Periorbital lines, Cheek augmentation, Nose, Nasal bridges, Earlobes 3. Lower face Nasolabial folds, Perioral lines, Marionette lines (Drool lines), Smile lines, Oral commissures, Lip enhancement, Chin augmentation. Mandibular line, Cheek augmentation 4. Skin rejuvenation Face, Neck, Decolletage, Hands Classification 2 (Table 1) Fillers can be classified in a variety of ways. For example, based on source they may be classified as autologous, biological, or synthetic; based on duration of cosmetic benefit they may be short (less than 3 months), medium (3-12 months), long (12-24 months), or very long (more than 24 months). Using reversibility as a criterion, fillers may be classified as very rapidly reversible, slowly biodegradable but not reversible, or non-biodegradable. GNEC, Maulana Azad Medical College, New Delhi Correspondence to : Dr. Saurabh Kamal drskamal@gmail.com Dermal Fillers Dermal fillers have become the cornerstone of facial filling in the office setting. Ideal dermal filler should be 3 Vol. 23, No.1, July - September, 2012 editordjo@gmail.com 61

2 DJO Easy to inject Produce reproducible results Have a longevity profile (long shelf life) that is satisfactory to both the patient and the physician Painless upon injection, non-allergenic (no skin testing prior to injection), non-carcinogenic, non-teratogenic, and one which, when injected, shows little migration over time Free from transmissible diseases Few or no untoward effects following the injection into the skin Affordable cost Collagen Bovine collagen was the first filler available and included the formulations of Zyderm and Zyplast (Allergan, Irvine,CA, USA). These products ranged from 35 to 65 mg/ ml bovine collagen and have 0.3% lidocaine. The main clinical advantage of the human collagen products is their ability to correct the most superficial lines with smooth flow characteristics as their carrier is phosphate-buffered saline. Disadvantages include allergic reactions, requirement of pre-treatment skin sensitivity test and short-lived effects. A porcine-derived collagen (Evolence ; OrthoNeutogena, NJ, USA) has shown good tolerability, more resistant to degradation without need for a skin test. Hyaluronans Hyaluronic acid (HA), or hyaluronan, is a glycosaminoglycan that consists of regularly repeating non-sulfated disaccharide units of glucoronic acid and N-acetylglucosamine. It is naturally occurring biopolymer with chemical structure that is invariant across species, thus exhibits no immunological reactions and implant rejection. Hyaluronan is highly hydrophilic and therefore, occupy a huge volume relative to its mass. To be suitable for use as skin filler, native hyaluronic acid is stabilized through a cross-link process. There are several differentiators among the commercially available HA. These include: the source, concentration, particulate size, cross-linking, type of crosslinking agent being used, and whether the HA is monophasic (more cohesive & do not migrate) or biphasic (customized for particular anatomic area), and whether an anaesthetic is added. Original HA fillers were made form avian rooster combs, but nowadays the source is bacteria-based, mainly from the fermentation of the Streptococcus equine bacterium (NASHA, Non-animal stabilized HA). The newer non-particulate HA fillers contain double or multiple crosslinking bonds, higher concentrations of HA and are long lasting. Those with concentrations of greater than 20 mg/ml are considered ideal. Advantages of HA over collagen are longer duration (6 12 months compared with 2 4 months), absence of requirement for skin testing, fewer allergic side effects and better pliability. Commercially available HA fillers of different pharmaceutical companies are discussed briefly: 1. JuvedermTM family (Allergan, Inc., Irvine, CA): It is produced from the bacterial fermentation of equine streptococci. The manufacturing process is referred to as Hylacross technology which refers to the fact that Juvéderm is not sized in contrast to the other HA filler. With a higher concentration and more cross-linking than other HA fillers, it has been suggested that the Juvederm family of products have smoother injection flow and may last longer. Six different formulations of Juvederm have been developed, with differing concentrations of HA ranging from 18 mg/g to 30 mg/g. The results last between 6 to 12 months with local injection site reactions being rare. 2. Restylane family (Q-Med, Upsalla, Sweden): It is also produced from equine streptococci. The HA concentration of Restylane is 20 mg/ml and its gel particle size is 400 μm. Restylane is injected easily through small-gauge (30 gauge) needles. Mild local injection site reactions and pain during the injection process are its major concerns as with other fillers. It has been used for the past several years with acceptable clinical results lasting for 6 to 12 months. 3. Hydrelle (Palo Alto, CA, USA): It contains the highest concentration of HA (28 mg/ml) and 0.3% lidocaine. In clinical practice, this material is easy to inject with a 27 gauge needle; however, the 30 gauge needle supplied with the syringe makes the injection process a little more difficult than most of the other HA fillers. The addition of lidocaine is a benefit and most patients note a decrease in pain, almost immediately after the injection Prevelle (Santa Barbara, CA, USA): Prevelle Silk contains mg/ml of HA, is 20% cross-linked with divinyl sulphone and has a gel particle size of 500 μm. Due to its low concentration and limited cross-linking, it produces minimal swelling and also has a shorter duration of effect. Prevelle Silk (with 0.3% lidocaine) is associated with decreased pain during and after the injection process. The majority of patients receiving Prevelle Silk do not have significant post-treatment erythema or posttreatment swelling. Non-absorbable fillers 1. Artefill (poly methylmethacryalate PMMA with collagen): It is a combination of bovine collagen and particles of polymethylmethacralate (PMMA). After resorption of the bovine collagen over 2-3 months and gel carrier, the resulting PMMA microspheres are surrounded by neocollagen. Skin testing is needed for artefill because of the bovine collagen component. 62 Vol. 23, No.1, July - September, 2012

3 TABLE 1. Classification of Dermal Fillers 2 Source Autologous Biological Synthetic Duration Of Cosmetic Benefit Temporary short duration Short duration Reversible (medium to long duration) Nonreversible long duration Nonreversible very long duration Nonreversible variable duration Risk profile Low Medium Higher Fat Collagen (Zyderm I, Zyderm II, Zyplast, CosmoDerm 1, CosmoDerm 2, CosmoPlast, Evolence ), Hyaluronic acid (HA) (Juvéderm Ultra, Juvéderm Ultra Plus, Restylane, Perlane ) Hydroxylapatite (Radiesse ), silicone oil (Silikon 1000), polymethylmethacrylate microspheres (ArteFill /ArteSense ), polyacrylamide hydrogel (Bio-Alcamid ), hydroxyethyl methacrylate/ethyl methacrylate (DermaLive /DermaDeep ), poly-llactic acid (Sculptra /New-Fill ) Saline Bovine collagen HA Hydroxylapatite, polyacrylamide hydrogel, porcine collagen Silicone oil, polymethylmethacrylate microspheres, hydroxethyl methacrylate/ethyl methacrylate, poly-l-lactic acid Fat Fat Saline, HA Collagen, hydroxylapatite, polymethylmethacrylate microspheres, poly-l-lactic acid, fat Silicone, polyacrylamide hydrogel, hydroxyethyl methacrylate/ ethyl methacrylate Level Of Physician Skill, Training, Experience, and Judgment Low Medium Saline HA, collagen High Hydroxylapatite, polymethylmethacrylate microspheres, poly-llactic acid, fat, silicone, polyacrylamide hydrogel, hydroxyethyl methacrylate/ethyl methacrylate Vol. 23, No.1, July - September, 2012 editordjo@gmail.com 63

4 DJO 2. Silicone: Liquid silicone fine droplet injection is used on a limited basis by certain physicians for long-term permanent corrections, but with significant risks.6 As this is a permanent material, correction of problems usually requires surgical excision. Off-label uses of ophthalmologic preparations (AdatoSil 5000 and Silikon 1000) of silicone have been adapted for use in the treatment of HIV-associated-lipoatrophy and other conditions of facial volume loss. Subcutaneous Volume Enhancers Autologous Fat The efficacy of autologous fat has been debated since its popularization in the 1990s owing to the lack of clinical objective data in the literature regarding longevity, predictability, and survivability of the fat grafts. There are conflicting results from studies, each recommending various techniques to improve the durability and survivability of transplanted fat. Success with fat grafting still varies among practitioners due to variability in harvest methods, placement techniques and choice of recipient site. The most common areas of the face which are treated with autologous fat grafts include the nasolabial groove, Marionnete lines, midface, and lips. 2 Autologous fat performs best in the midface area considering the longevity compared to other more mobile areas such as lips and Marionette grooves. The challenging areas for successful fat grafting include the nasojugal area and lower lid creases. These areas are the most technique-dependent for obtaining smooth results and greater complications arise with fat grafting in these areas. Gentle handling of fat with some sort of separation from oils and blood can be accomplished through gravity decantation or centrifugation. Transfer of the harvested fat to 1-mL syringes and blunt cannulas of various curves and sizes offers precise placement of small 0.1-mL aliquots of fat. Using blunt cannulas, low pressure and typically depositing on withdrawal of the cannula allow for more precise placement of fat pearls at various levels including intramuscular levels. Biodegradeable microparticle injectible implants 1. Calcium hydroxylapatite: It contains smooth spheres of (30%) calcium hydoxylapatite (25-45 microns) and 70% carboxymethylcellulose gel suspension. This gives the product a white colour which is then injected subdermally typically in a threading technique using a unique 28-gauge needle. Marketed as Radiesse, it is indicated for correction of lipoatrophy in persons with AIDS. Although it can appear radiopaque in radiographic films there is no indication that it causes masking of abnormal tissues. 5 Palpable nodules especially in lips can be noted as collagen forms around microspheres of calcium hydroxylapatite. Treatment of nodules can be reversed by a slit incision and removal. 2. Poly-L-Lactic Acid (PLLA): It is marketed as Sculptra and supplied as a vial (367.5 mg) of freeze dried powder of synthetic PLLA, sodium carboxymethylcellulose, and mannitol. This vial is reconstituted with sterile water atleast 2 hours prior to use. It produces a controlled inflammation where fibroblasts leave collagen as the PLLA is degraded. Clinical results are typically seen after 4 to 6 weeks. Sculptra should not be injected in the periorbital area or the lips due to formation of nodules in these areas. Procedural Consideration and Planning History A complete medical history, including medication list, should be elicited. As with any invasive procedure, the patient may be asked to not take aspirin for atleast 8 days, or nonsteroidal anti-inflammatory drugs for atleast 5days, unless discontinuation of these poses a significant risk to the patient. If the patient is on warfarin therapy, the prothrombin time should be under 2.0 so that the risk of hematoma or excessive bruising is low. Herbal medications (e.g. gingko biloba, vitamin E, garlic, ginseng, fish oil) predispose to bleeding and should be with held, if possible. The only absolute contraindication is known allergy to specific filler. Patient Comfort techniques These includes Icing to reduce pain and bruising (before, during, and after treatment), Topical anesthesia (4% lidocaine gel or EMLA), Nerve block anesthesia (Infraorbital and Mental nerve block), Infiltrative anesthesia, or distraction technique such as massaging, vibrator anesthesia, or talkesthesia (hand holding and talking). Injection Technique Dermal fillers are injected at the mid-dermis or upto dermis-subcutaneous junction using 30-gauge, half inch needle. If injection is too deep or into the muscles, it reduces the duration of effect and if injected superficially, there may be areas of excess fullness or bluish coloration. There are four techniques developed to inject fillers. Serial puncture Consists of making several punctures along fine lines, folds or wrinkles. The advantage of this technique is more control and precise placement but need for several needle sticks. Linear threading - It delivers the filler continuously along either most or the entire length of the defect with only single or few punctures. It can be either retrograde (injecting while withdrawing) or anterograde (injecting while pushing ahead needle). Some believe that anterograde is less painful and may also minimize trauma by hydrodissecting the target tissue to create a potential space for receiving the filler but injecting while 64 Vol. 23, No.1, July - September, 2012

5 withdrawing reduces the risk of intravascular injection. Slowly injecting the filler reduces post procedural bruising, ensure precise delivery, avoids any unwanted nodules and textural irregularities. Fanning Similar to linear threading but the direction of needle is continually changed and new lines are injected without withdrawing the needle tip. It is used for large areas and reduces chances of bruising. Cross-hatchings Utilizes two series of linear threads approximately 5-10 mm apart at right angles to each other. Used for large areas and facial shaping. Post-Procedure Management Cold compresses or ice following the procedure may reduce some of the swelling and tenderness from the multiple injections. Avoid strenuous physical activity and self massaging for 6 hours. Patient should be also instructed to sleep with head elevated for one night and resume skin care products, the next day. Complications Expected problems include acneiform eruptions, over or under corrections, injection discomfort, bruising and bleeding, erythema after injection, and mild treatment asymmetry. Asymmetry can be treated with a touch-up procedure. Lumpiness and dimpling is usually the result of placing the material into superficial plane, and this will usually resolve spontaneously or with massage. 6 If required, nodules can be dissipated by injection of hyaluronidase. 7 Uncommon complications include inflammatory nodules, allergic reactions, infection, hematomas, granulomas, and blue lump (Tyndall effect). True granulomas can be treated with a low-dose steroid injection and may need to be excised. Common Injection Areas (Aesthetic and Therapeutic) Glabella Wrinkles and furrows frequently develop between the eyebrows. The best treatment is through injection of Botox followed by HA filler (0.4 ml) at same session or after 1-2 weeks. Usually the effect lasts for more than 6-9 months. Brow Aging leads to drooping and receding of Brow. It is treated by filling across the lateral brows starting just below the cilia towards the supraorbital notch, and thereby elevating the superolateral margin. The amount needed is usually ml. As eyelid skin is thin, any lumpiness or unevenness can be particularly visible and area is also susceptible to hematoma because of larger vessels. Effect of brow elevation can be increased by using Botox simultaneously. Crow s Feet Typically the crow s feet are treated by use of Botox, but inferior lines are treated with HA filler due to the risk of paralysing zygomaticus major muscle which could result in hemifacial paralysis. The skin is resuspended over the zygomatic convexity induced by the use of fillers. Tear Troughs It is the inferior hollow periorbital area usually on medial side but also may be present laterally. It is usually a deep injection in pre-periosteum plane deep to the orbicularis and anterior to the inferior orbital rim. 8 Paralytic lagophthalmos The hyaluronic acid gel can be used for non-surgical management of lagophthalmos in cases where return of facial nerve function is anticipated or poor surgical candidates. Injection can be made into upper lid pre-levator or pre-tarsal region ranging from ml with significant improvement in lagophthalmos and exposure keratopathy. 9 Upper eyelid contouring HA fillers can be used for generalised/medial upper lid hollow and post-blepharoplasty upper lid show. 10 Congenital lid malpositions HA fillers can temporarily correct upper or lower eyelid retraction, ectropion, euryblepharon, epiblepharon, and abnormalities associated with a shallow orbit. 11 Anophthalmic socket and phthisical eyes Orbital volume augmentation can be achieved with 2-4 ml injection of HA fillers with effects lasting for 12 months. 12 Conclusions Soft tissue augmentation with fillers is a composite of art and science. The current options for soft tissue augmentation have increased because of the safety and differentiation of the injectible products. The use of different variety of fillers requires acquisition of knowledge and skill by the physician pertaining to the respective product. A physician's skill, combined with appropriate patient assessment and education, is the key to successful outcomes. The increasing acceptability by both the physician and patient will make the use of soft tissue fillers more widespread in the years to come. Vol. 23, No.1, July - September, 2012 editordjo@gmail.com 65

6 DJO References 1. Newman J. Review of soft tissue augmentation in the face. Clin Cosmet Investig Dermatol 2009; 28(2): Smith KC. Reversible vs. nonreversible fillers in facial aesthetics: concerns and considerations. Dermatol Online J 2008; 14(8):3. 3. Gold MH. Use of hyaluronic acid fillers for the treatment of the aging face. Clin Interven Aging 2007; 2(3): Levy PM, de Boulle K, Raspaldo H. Comparison of injection comfort of a new category of cohesive hyaluronic acid filler with preincorporated lidocaine and hyaluronic acid filler alone. Dermatol Surg 2009; 35: Tzikas TL. Evaluation of Radiance FN soft tissue filler for facial soft tissue augmentation. Arch Facial Plast Surg 2004; 6(4): Rapaport MJ, Vinnik C, Zarem H. Injectable silicone: cause of facial nodules, cellulitis, ulceration, and migration. Aesthetic Plast Surg 1996; 20(3): Rzany B, Becker-Wegerich P, Bachmann F, Erdmann R, Wollina UJ. Hyaluronidase in the correction of hyaluronic acid-based fillers: a review and a recommendation for use. J Cosmet Dermatol 2009; 8(4): Morley AM, Malhotra R. Use of hyaluronic acid filler for tear-trough rejuvenation as an alternative to lower eyelid surgery. Ophthal Plast Reconstr Surg 2011; 27(2): Mancini R, Taban M, Lowinger A, Nakra T, Tsirbas A, Douglas RS, Shorr N, Goldberg RA. Use of hyaluronic Acid gel in the management of paralytic lagophthalmos: the hyaluronic Acid gel gold weight. Ophthal Plast Reconstr Surg 2009; 25(1): Morley AM, Taban M, Malhotra R, Goldberg RA. Use of hyaluronic Acid gel for upper eyelid filling and contouring. Ophthal Plast Reconstr Surg 2009; 25(6): Taban M, Mancini R, Nakra T, Velez FG, Ela-Dalman N, Tsirbas A, Douglas RS, Goldberg RA. Nonsurgical management of congenital eyelid malpositions using hyaluronic Acid gel. Ophthal Plast Reconstr Surg 2009; 25(4): Zamani M, Thyagarajan S, Olver JM. Adjunctive use of hyaluronic acid gel (Restylane Sub-Q) in anophthalmic volume deficient sockets and phthisical eyes. Ophthal Plast Reconstr Surg 2010; 26(4): Announcement Delhi Journal of Ophthalmology The Best Original article published in the Delhi journal of ophthalmology in a calender year will be awarded in the DOS Annual Conference. Editorial Office Dr.Rajesh Sinha Editor, DJO & Associate Proff.of Ophthalmology Room. No. 479, Dr.R.P. Centre for Ophthalmic Sciences, AIIMS, Ansari Nagar, New Delhi Vol. 23, No.1, July - September, 2012