Comparison of the performance and safety of 2 ophthalmic viscosurgical devices in cataract surgery.

PURPOSE: To compare the clinical performance and safety of 2 ophthalmic viscosurgical devices (OVDs)-Twinvisc (OVD 1) and Duovisc (OVD 2)-in cataract surgery. SETTING: European multicenter study. DESIGN: Prospective randomized controlled study. METHODS: Patients with cataract had phacoemulsification and intraocular lens implantation in 1 eye. They were randomly assigned to receive OVD 1 or OVD 2. Preoperative and postoperative examinations over 3 months included mean intraocular pressure (IOP), incidence of IOP peaks (≥30 mm Hg and ≥24 mm Hg), endothelial cell count (ECC), corneal thickness, and intraocular inflammation. A subjective evaluation of the OVDs was performed. RESULTS: The study comprised 220 patients. The incidence of IOP peaks and the mean IOP were not statistically significantly different between the 2 groups at any of the follow-up visits. At 6 hours, the incidence of IOP spikes 30 mm Hg or higher was 6.5% and 7.2% in the OVD 1 and the OVD 2 groups, respectively (P = .846). For the IOP spikes 24 mm Hg or higher, the incidence was 16.8% and 25.2%, respectively (P = .128). Three months postoperatively there was no statistically significant difference in ECC and pachymetry between the 2 groups. Mild inflammation was noticed up to 7 days postoperatively after which it resolved in both groups. Subjectively, the OVD 2 was easier to use, whereas the OVD 1 had better cohesive and dispersive properties. CONCLUSIONS: Both OVDs have similar performance and safety profiles in phacoemulsification cataract surgery. No clinically relevant differences were found between the 2 devices regarding transient IOP spikes, mean IOP, corneal endothelium injury, or inflammation.

Tear trough rejuvenation: A safety evaluation of the treatment by a semi-cross-linked hyaluronic acid filler.

The aim of this study is to describe the experience of 33 physicians, dermatologists and surgeons, with the use of a semi-cross-linked hyaluronic acid (HA) gel as a tear trough deformity filler within one month following injection, and to assess patient satisfaction with the procedure. This study is a case series conducted between February 2012 and December 2012 with the use of semi-cross-linked HA to correct tear trough deformity. The filler was administered in the preperiosteal tissues. The study involved case note review and a patient satisfaction survey. A total of 302 eyes of 151 patients were treated by 33 physicians, with a mean follow-up of 3 weeks. Patients were mainly female (86%), and middle-aged (mean age 48 years old). The gel was placed preperiosteally, deep to the orbicularis, anterior to the inferior orbital rim, with a mean volume of 0.48 ml per eye to achieve correction. The injection procedure was performed without local anesthetic for 79% of the patients. No serious adverse event was recorded. Side effects reported by investigators immediately after injection included bruising (11%), swelling (12%), and redness (inflammation 12%). Very few transitional blue discolorations (2.6%) were observed. No patient required dissolution with hyaluronidase. According to our satisfaction survey, all patients had cosmetic improvement. Most patients (97%) described marked or moderate satisfaction with the treatment. At one month, 18% requested additional hyaluronic acid gel for a touch-up injection. This case series confirms the effective use of a semi-cross-linked HA gel in tear trough rejuvenation. It has excellent patient tolerability, minimal complications, and excellent patient satisfaction.

Xanthelasma-Like Reaction to Filler Injection.

PURPOSE: The purpose of this study is to describe a new complication of a xanthelasma-like reaction which appeared after dermal filler injection in the lower eyelid region. METHODS: A retrospective case analysis was performed on 7 patients presenting with xanthelasma-like reaction after filler injection to the lower eyelids. RESULTS: Seven female subjects with no history of xanthelasma presented with xanthelasma-like reaction in the lower eyelids post filler injection. Fillers included hyaluronic acid (2 patients), synthetic calcium hydroxyapatite (4 patients), and polycaprolactone microspheres (one patient). Average time interval between filler injection and development of xanthelasma-like reaction was 12 months (range: 6-18 months). Treatment included steroid injections, 5FU injections, ablative or fractionated CO2 laser, and direct excision. Pathology confirmed the lesion was a true xanthelasma in one patient. In treated patients, there was subtotal resolution after laser. Xanthelasma-like reaction resolved completely after direct excision. Three patients elected to have no treatment. CONCLUSIONS: Previously there has been one reported case of xanthelasma after filler injection. This case series is the largest to date. Furthermore, this series is notable because xanthelasma-like reactions appeared after injection with 3 different types of fillers. None of the patients had evidence of xanthelasma prefiller injection. The precise mechanism by which filler injection can lead to the formation of xanthelasma-like reaction is unclear. A possible mechanism may be related to binding of low-density lipoprotein and internalization by macrophages. Further investigation is required. Nevertheless, physicians performing filler injections should be aware of this new complication and treatment options.

Treatment of Hyaluronic Acid Filler-Induced Impending Necrosis With Hyaluronidase: Consensus Recommendations.

Injection-induced necrosis is a rare but dreaded consequence of soft tissue augmentation with filler agents. It usually occurs as a result of injection of filler directly into an artery, but can also result from compression or injury. We provide recommendations on the use of hyaluronidase when vascular compromise is suspected. Consensus recommendations were developed by thorough discussion and debate amongst the authors at a roundtable meeting on Wednesday June 18, 2014 in Las Vegas, NV as well as significant ongoing written and verbal communications amongst the authors in the months prior to journal submission. All authors are experienced tertiary care providers. A prompt diagnosis and immediate treatment with high doses of hyaluronidase (at least 200 U) are critically important. It is not felt necessary to do a skin test in cases of impending necrosis. Some experts recommend dilution with saline to increase dispersion or lidocaine to aid vasodilation. Additional hyaluronidase should be injected if improvement is not seen within 60 minutes. A warm compress also aids vasodilation, and massage has been shown to help. Some experts advocate the use of nitroglycerin paste, although this area is controversial. Introducing an oral aspirin regimen should help prevent further clot formation due to vascular compromise. In our experience, patients who are diagnosed promptly and treated within 24 hours will usually have the best outcomes.

Hyaluronic acid viscosupplements from avian and non-mammalian sources exhibit biocompatibility profiles with unique, source-specific, antigenic profiles.

The objective of this study was to evaluate and compare the biocompatibility profiles of hyaluronic acid (HA) viscosupplements from avian and non-mammalian sources. Inflammatory and immune reactions were assessed in models of both clinically relevant and stringent immunological exposure conditions. Experiments were conducted to evaluate tissue reactions and immunological responses and assess antibody formation with the capacity to bind directly to and cross-react with the different viscosupplements. Mice were exposed to viscosupplements using the air pouch inflammation model and specific immunization using Freund's complete adjuvant (FCA). Murine pouch membrane tissue reactions revealed generally mild to moderate responses, with cellular infiltration and cytokine profiles of pouch tissue characteristic of predominantly fibroblastic responses rather than marked inflammatory reactions. In vitro testing indicated that pouch injections did not elicit detectable T-cell proliferative responses, while antibody assays revealed that mice immunized with viscosupplements in FCA and subsequently boosted were capable of mounting an antibody response with a range of specificities. High reactivity to avian serum albumin was seen in sera from mice injected with HA from an avian source, while low positive reactivity to the bacterial antigen Staphylococcal Lipotechoic Acid was observed in sera from mice injected with HA from bacterial sources. These specificities did not indicate any propensity to cross-react, suggesting that patients with adverse immune responses to HA from an avian source should be unresponsive to subsequent injection with HA from a non-avian source. Overall, the findings demonstrate that viscosupplements exhibit good biocompatibility profiles in the murine air pouch, but when provoked to elicit immunological reactions exhibit unique antigenic spectra. These findings suggest that an immunologically mediated immune reaction directed against avian proteins should not necessarily be a contraindication for the administration of non-avian viscosupplements.

[Macrolane®: A severe case of calf cellulitis after modeling injection]. / Macrolane® : un cas grave de cellulite du mollet après injection modelante.

In recent years, the market for resorbable injectables has been steadily expanding. The European Community's seal of approval (CE) is a sufficient guaranty to get them distributed. These injectables do not require official approval because they are considered to be "implantable medical devices" and not medicines. Macrolane(®)is a hyaluronic acid in gel form (NASHA [non-animal stabilized hyaluronic acid]) and has been on the French market since 2007. It can be injected into all areas except the face. It is highly cross-linked which, while slowing its absorption into the body, can also leave long-lasting residues. We report the first case of cellulitis after injection into the calf by a practitioner in his office.

Autologous conditioned serum (Orthokine) is an effective treatment for knee osteoarthritis.

OBJECTIVE: Osteoarthritis (OA) is prevalent and difficult to treat. Autologous conditioned serum (ACS), marketed under the trade name Orthokine, is a novel, injectable antiarthritic derived from the patient's own blood. The present study is the first time ACS has undergone a controlled clinical trial. METHOD: We investigated 376 patients with knee OA in a prospective, randomized, patient- and observer-blinded, placebo-controlled trial using an intention-to-treat analysis (ITT). The clinical effects of ACS were compared to hyaluronan (HA) and saline (placebo) as assessed by patient-administered outcome instruments (Western Ontario and McMaster Universities osteoarthritis index, global patient assessment, visual analog scale, Short-Form 8) after 7, 13 and 26 weeks. After 104 weeks an observer-blinded follow-up was carried out. Frequency and severity of adverse events were used as safety parameters. RESULTS: In all treatment groups, intra-articular injections produced a reduction in symptoms as well as an improvement in quality of life. However, the effects of ACS were significantly superior to those of HA and saline for all outcome measures and time points, and improvements were clinically relevant; there were no differences between the effects of HA and saline. The frequency of adverse events was comparable in the ACS and saline groups, but higher in the HA group. CONCLUSION: The data demonstrate that ACS injection considerably improves clinical signs and symptoms of OA. It remains to be determined whether ACS is disease-modifying, chondroprotective, or chondroregenerative.