Comparative Assessment of Intraocular Inflammation Following
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Acta Ophthalmologica 2019 Comparative assessment of intraocular inflammation following standard or heavy silicone oil tamponade: a prospective study Francesco Semeraro,1 Andrea Russo,1 Francesco Morescalchi,1 Elena Gambicorti,1 Sara Vezzoli,2 Francesco Parmeggiani,3 Mario R. Romano4 and Ciro Costagliola5 1Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Italy 2Department of Medical and Surgical Specialties, Radiological Sciences and Public Health – Section of Legal Medicine, University of Brescia, Brescia, Italy 3Department of Ophthalmology, University of Ferrara, Ferrara, Italy 4Department of Biomedical Sciences, Humanitas University, Milan, Italy 5Department of Medicine and Health Sciences, University of Molise, Campobasso, Italy ABSTRACT. vitreous substitute (Cibis et al. 1962). Purpose: To evaluate the inflammation associated with the use of standard The use of a vitreous substitute that is silicone oil (polydimethylsiloxane; PDMS) and heavy silicone oil (HSO) heavier than water has been recently Densiron-68TM in patients undergoing vitrectomy for retinal detachment. suggested for use as an intraocular Materials and Methods: A prospective study was performed involving 35 patients tamponade in surgical cases of compli- scheduled to undergo vitrectomy for retinal detachment. Patients received PDMS cated retinal detachment of the inferior or Densiron-68TM HSO according to superior or inferior retinal localization of the quadrants (Azen et al. 1998). To date, three groups of heavy tamponades have tears, respectively. For assessing the inflammation, prostaglandin E2 (PGE2) and interleukin-1a (IL-1a) levels were evaluated in the aqueous. been introduced into surgical practice: Results: Thirty-five eyes of 35 patients completed the study: 20 eyes received fluorinated silicone oil or fluorosilicone, perfluorocarbon liquids and semifluori- HSO, and 15 eyes received PDMS. The mean aqueous PGE2 level was Æ nated alkanes, such as perfluorohexy- significantly higher in HSO patients than in PDMS patients (869.16 loctane (F H ) (Morescalchi et al. Æ < 6 8 242.83 pg/ml versus 369.38 209.7 pg/ml, respectively; p 0.0001). The mean 2014). Densiron-68TM is a commonly aqueous IL-1a level was also significantly higher in HSO patients than in PDMS used solution comprising F6H8 and patients (81.40 Æ 36.9 pg/ml versus 40.8 Æ 32.5 pg/ml, respectively; p = 0.002). 5000c silicone oil, with a specific gravity In HSO, a moderate positive correlation between the endotamponade duration and of 1.06 and a viscosity of 1387 mPas. both PGE2 (r = 0.44; p = 0.05) and IL-1a (r = 0.48; p = 0.033) levels was According to the evidence reported observed. In PDMS, a strong positive correlation between the endotamponade in the literature, the heavy tamponades duration and both PGE2 (r = 0.89; p < 0.0001) and IL-1a (r = 0.68; p = 0.006) are more prone to cause intraocular levels was observed. inflammation compared with standard Conclusion: Although both HSO and PDMS yielded favourable success rates in silicone oil, especially if they remain in the surgical treatment of complicated retinal detachments, HSO triggered a the eye for several months (Morescal- more severe inflammatory reaction, in a time-dependent manner. chi et al. 2014). Side-effects of heavy silicone oil (HSO) are associated with the chemical and physical properties of Key words: heavy silicone oil – inflammation – retinal detachment – standard silicone oil – vitrectomy the tamponading compound and are similar to those associated with con- ventional silicone oil (Semeraro et al. Acta Ophthalmol. 2019: 97: e97–e102 2014). Four main mechanisms are ª 2018 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd reported in the genesis of the inflam- doi: 10.1111/aos.13830 matory reaction to standard and HSO: direct toxicity and immunogenicity, Introduction substitute in vitreoretinal surgery over toxicity due to impurities or instability Introduced in 1962, silicone oil has been the past 50 years, and to date, it remains of the agent, oil emulsification and the most commonly used vitreous the only widely accepted long-term mechanical injury due to gravity e97 Acta Ophthalmologica 2019 (Mackiewicz et al. 2007). However, the PDMS silicone oil (100% PDMS; den- Table 1. Patient demographics and baseline inflammation associated with HSO sity 970 kg/m3; Alchimia Srl, Ponte characteristics. appears to be due to a delayed type San Nicolo, PD, Italy), and 20 eyes TM HSO PDMS IV hypersensitivity reaction and varies received HSO Densiron-68 (mixture (N = 20) (N = 15) greatly because the duration of appli- of 69.5% ultrapure PDMS and 30.5% cation significantly affects the level of perfluorohexyloctane; viscosity of Age: mean 62.3 (16.7) 58.9 (12.8) inflammation in the eye (Morescalchi 1200 cSt and density of 1040 kg/m3; (SD), years et al. 2014). Fluoron GmbH, Ulm, Germany) Sex: n (%) For the safe and effective use of according to superior or inferior retinal Men 15 (75) 11 (73) retinal tamponades, an awareness of localization of the tears, respectively Women 5 (25) 4 (27) Lens status (%) their physical, chemical and inflamma- (Table 2). Phakic 10 (50) 6 (40) tory properties is a prerequisite; vitre- All phakic patients were operated Pseudophakic 10 (50) 9 (60) oretinal surgeons select the most with phacoemulsification of the crys- Preoperative 0.15 (0.12) 0.14 (0.09) suitable tamponade on the basis of talline lens plus intraocular lens (IOL) visual this knowledge. In this study, we implant at the time of vitrectomy to acuity: mean prospectively evaluated the inflamma- allow a careful cleaning of the vitre- (SD), decimal tion associated with both 1000 cSt ous base. Vitrectomy surgery was HSO = heavy silicone oil, PDMS = poly- silicone oil (100% polydimethylsilox- performed using a 23-gauge transcon- dimethylsiloxane, SD = standard deviation. ane; PDMS) and 1200 cSt HSO (Den- junctival system, and no triamcinolone siron-68TM) in patients undergoing was used during any step of the vitrectomy for retinal detachment. To surgery. determination of prostaglandin E2 the best of our knowledge, this is the After the removal of the posterior (PGE2) levels. Analyses were performed first study designed to compare the hyaloids, the vitreous base was thor- using Dynex Technologies DSXTM (v. inflammatory complications associated oughly removed. All visible proliferative 6.03; Chantilly, VA, USA) according to with Densiron-68TM and standard sili- vitreoretinopathy (PVR) membranes the manufacturer’s instructions. Briefly, cone oil. were dissected, and relaxing retino- the analysis was based on the competi- tomies were performed, in two eyes, in tion between PGE2 and PGE2-acetyl- Materials and Methods the inferior retina of PDMS group. The cholinesterase conjugate (AChE; PGE2 retinal periphery was inspected for reti- tracer) for a limited amount of PGE2 This study was conducted at the nal breaks that were marked with endo- monoclonal antibody. As the concen- University Eye Clinic of ‘Spedali diathermy, after that the retina was tration of the PGE2 tracer was constant Civili di Brescia’ in accordance with reattached using perfluorocarbon liquid while the concentration of PGE2 sam- the ethical principles of the Declara- and air. Three rows of endolaser treat- ples varied, the amount of PGE2 tracer, tion of Helsinki. The Ethics Commit- ment were applied behind the posterior which was able to bind to the PGE2 tee of Spedali Civili di Brescia (Italy) vitreous base in all patients (200 spots, monoclonal antibody, was inversely approved the study protocol (regis- 200–250 mW according to retinal pig- proportional to the concentration of tered with clinicaltrials.gov, identifier mentation). Finally, after a complete PGE2 in the well. NCT02361645). All study participants perfluorocarbon liquid-to-air exchange, The interleukin-1a (IL-1a) assay was provided written informed consent. the eye was filled with PDMS or Den- based on a double-antibody ‘sandwich’ This was a prospective study includ- siron-68TM according to tear localiza- technique. Each well of the microtiter ing 35 eyes of 35 patients consecutively tion. All patients in both groups were plate supplied with the kit was coated enrolled from September 2015 to prescribed topical dexamethasone (six with a monoclonal antibody specific March 2016; the patients were sched- times per day) and homatropine (two for IL-1a. This antibody can bind to uled to undergo 23-gauge, three-port times per day). any IL-1a introduced into the well. An pars plana vitrectomy for retinal Both PDMS and HSO were AChE that binds selectively to a dif- detachment, and all patients completed removed using a 23-gauge instrument. ferent epitope on IL-1a was also added the study. Inclusion criteria were age Patients with PDMS were positioned in to the well, forming a ‘sandwich’ by ≥18 years and retinal detachment with prone position for 2 hr before the binding on opposite sides of the IL-1a multiple or giant breaks, such as it surgery, while patients with HSO were molecule. The concentration of the requires the tamponade with silicone maintained in supine for the same analyte was then determined by mea- oil. The exclusion criteria were diabetes amount of time. At the beginning of suring the enzymatic activity of the mellitus, previous vitrectomy in the the surgery, 0.5–1.0 ml of undiluted AChE by adding Ellman’s reagent to study eye, previous buckle surgery, aqueous was removed before opening each well. previous intravitreal injection, concur- the infusion. Samples were immediately rent retinovascular or other ocular frozen and stored at À40 °C until Statistical analysis inflammatory disease, history of ocular analysis. trauma and concomitant intake of any Descriptive statistics were used to pre- topical or systemic NSAID or corti- sent demographic and ocular baseline Measurements of prostaglandin E2 and costeroid therapy. characteristics. An independent-sam- interleukin-1a levels Patient demographics and baseline ples t-test was performed to determine characteristics are listed in Tables 1 Vitreous samples were defrosted whether there were differences in PGE2 and 2.