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      A pilot study of intraocular use of intensive anti-inflammatory; triamcinolone acetonide to prevent proliferative vitreoretinopathy in eyes undergoing vitreoretinal surgery for open globe trauma; the adjuncts in ocular trauma (AOT) trial: study protocol for a randomised controlled trial


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          Eyes sustaining open globe trauma (OGT) is a group at high risk of severe visual impairment. Proliferative vitreoretinopathy (PVR) is the commonest cause of retinal redetachment in these eyes and is reported to occur in up to 45% of cases. Intensive anti-inflammatory agents have been shown to be effective at modifying experimental PVR and to be well tolerated clinically.

          The Adjuncts in Ocular Trauma (AOT) Trial was designed to investigate the benefits of using intensive anti-inflammatory agents (intravitreal and sub-Tenon’s triamcinolone, oral flurbiprofen and guttae prednisolone 1.0%) perioperatively in patients undergoing vitrectomy surgery following open globe trauma.


          Patients requiring posterior vitrectomy surgery following open globe trauma will be randomised to receive either standard treatment or study treatment. Both groups will receive the standard surgical treatment appropriate for their eye condition and routine perioperative treatment and care, differing only in the addition of supplementary adjunctive agents in the treatment group. The investigated primary outcome measure is anatomical success at 6 months in the absence of internal tamponade.


          This is the first randomised controlled clinical trial to investigate the use of adjunctive intensive antiinflammatory agents in patients undergoing vitrectomy following open globe trauma. It will provide evidence for the role of these adjuncts in this group of patients, as well as provide data to power a definitive study.

          EudraCT No


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          Most cited references34

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          The global impact of eye injuries.

          Using data compiled from the ophthalmic literature and WHO's Blindness Data Bank, the available information on eye injuries from an epidemiological and public health perspective has been extensively reviewed. This collection of data has allowed an analysis of risk factors, incidence, prevalence, and impact of eye injuries in terms of visual outcome. However, most of the estimates are based on information from More Developed Countries (MDCs). The severity of eye injuries can be assessed through proxy indicators such as: (i) potentially blinding bilateral injuries; (ii) open-globe injuries; (iii) endophthalmitis; (iv) enucleation or (v) defined visual impairment. Major risk factors for ocular injuries include age, gender, socioeconomic status and lifestyle. The site where the injury occurs is also related to a risk situation. Available information indicates a very significant impact of eye injuries in terms of medical care, needs for vocational rehabilitation and great socioeconomic costs. The global pattern of eye injuries and their consequences emerging from the present review, undertaken for planning purposes in the WHO Programme for the Prevention of Blindness, suggests that: some 55 million eye injuries restricting activities more than one day occur each year; 750,000 cases will require hospitalization each year, including some 200,000 open-globe injuries; there are approximately 1.6 million blind from injuries, an additional 2.3 million people with bilateral low vision from this cause, and almost 19 million with unilateral blindness or low vision. Further epidemiological studies are needed to permit more accurate planning of prevention and management measures; a standardized international template for reporting on eye injuries might be useful to this effect, along the lines of the reporting occurring through the US Eye Injury Registry.
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            Intraocular concentration and pharmacokinetics of triamcinolone acetonide after a single intravitreal injection.

            To describe the pharmacokinetics occurring after the direct injection of triamcinolone acetonide into the vitreous humor of humans. Interventional case series. Five patients who received a single 4-mg intravitreal injection of triamcinolone acetonide. An aqueous humor sample was obtained from 5 eyes via an anterior chamber paracentesis at days 1, 3, 10, 17, and 31 after injection. At each visit, visual acuity and intraocular pressure were measured and indirect ophthalmoscopy was performed. A fluorescein angiogram was carried out at day 10. Concentrations were determined using high performance liquid chromatography; pharmacokinetic analysis was carried out using PK Analyst, an iterative, nonlinear, weighted, least-squares regression program. Intraocular concentrations of triamcinolone were measured and population pharmacokinetic parameters were calculated. Pharmacokinetic data followed a two-compartment model. Peak aqueous humor concentrations ranged from 2151 to 7202 ng/ml, half-lives from 76 to 635 hours, and the integral of the area under the concentration-time curve (AUC(0-t)) from 231 to 1911 ng/h per milliliter. After a single intravitreal injection of triamcinolone, the mean elimination half-life was 18.6 days in nonvitrectomized patients. The half-life in a patient who had undergone a vitrectomy was shorter at 3.2 days. There was considerable intrasubject variation among peak concentration, AUC(0-t) values, and elimination half-lives. After intravitreal injection, measurable concentrations of triamcinolone would be expected to last for approximately 3 months (93 +/- 28 days) in the absence of a vitrectomy. Because triamcinolone pharmacokinetics were characterized only in elderly patients with macular edema, the results cannot be extrapolated to other patient populations.
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              An updated classification of retinal detachment with proliferative vitreoretinopathy.

              The Retinal Society classification on proliferative vitreoretinopathy of 1983 has been updated to accommodate major progress in understanding of this disease. There are three grades describing increasing severity of the disease. Posterior and anterior location of the proliferations have been emphasized. A more detailed description of posterior and anterior contractions has been made possible by adding contraction types such as focal, diffuse, subretinal, circumferential contraction, and anterior displacement. The extent of the abnormality has been detailed by using clock hours instead of quadrants.

                Author and article information

                BioMed Central
                13 February 2013
                : 14
                : 42
                [1 ]Moorfields Eye Hospital NHS Foundation Trust, City Road, London, EC1V 2PD, UK
                [2 ]Royal Air force and Worcestershire Acute Hospitals NHS Trust, Charles Hastings Way, Worcester, WR5 1DD, UK
                [3 ]Birmingham and Midland Eye Centre, Dudley Road, Birmingham, B18 7QH, UK
                Copyright ©2013 Banerjee et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                : 12 June 2012
                : 29 January 2013
                Study Protocol



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