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Corneal toxicity after Ozurdex® migration into anterior chamber
ARTICLE IN PRESS a r c h s o c e s p o f t a l m o l . 2 0 1 6;x x x(x x):xxx–xxx
ARCHIVOS DE LA SOCIEDAD ESPAÑOLA DE OFTALMOLOGÍA www.elsevier.es/oftalmologia
Short communication
Corneal toxicity after Ozurdex® migration into anterior chamber夽 L. Bernal ∗ , B. Estévez Servicio de Oftalmología, Complejo Hospitalario Universitario Insular Materno Infantil, Las Palmas de Gran Canaria, Spain
a r t i c l e
i n f o
a b s t r a c t
Article history:
Objective: To describe a case of corneal toxicity after migration of a dexamethasone implant
Received 30 May 2015
into the anterior chamber.
Accepted 12 January 2016
Case report: A 62-year-old man with aphakia and a history of vitrectomy received a dexa-
Available online xxx
methasone implant for a refractory Irvine-Gass syndrome.
Keywords:
contact with secondary corneal oedema that justified the removal of the implant without
Dexamethasone implant
resolution of the oedema.
Thirty days later, the implant migrated into the anterior chamber causing endothelial
Ozurdex®
Discussion: Clinical tolerability to dislocated implant is poor in cases with pre-existing
Migration into anterior chamber
corneal oedema, and because of this, it must be removed early. In cases of aphakia and vit-
Corneal oedema
rectomy, the increased risk of Ozurdex® dislocation justifies performing a prior endothelial count. ˜ © 2016 Sociedad Espanola de Oftalmología. Published by Elsevier España, S.L.U. All rights reserved.
Toxicidad corneal tras migración de Ozurdex® a cámara anterior r e s u m e n Palabras clave:
Objetivo: Presentamos un caso de toxicidad corneal tras migración de un implante de de-
Implante de dexametasona
xametasona (Ozurdex® ) hacia la cámara anterior.
Ozurdex®
˜ Caso clínico: Varón de 62 anos afáquico y vitrectomizado, recibe un implante Ozurdex® por
Migración en cámara anterior
síndrome de Irvine-Gass refractario. Treinta días después el implante migra hacia la cámara
Edema de córnea
anterior produciendo edema corneal por contacto endotelial, que justificó la retirada del dispositivo, sin resolución del edema.
夽 Please cite this article as: Bernal L, Estévez B. Toxicidad corneal tras migración de Ozurdex® a cámara anterior. Arch Soc Esp Oftalmol. 2016. http://dx.doi.org/10.1016/j.oftal.2016.01.008 ∗ Corresponding author. E-mail address: laura [email protected] (L. Bernal). ˜ 2173-5794/© 2016 Sociedad Espanola de Oftalmología. Published by Elsevier España, S.L.U. All rights reserved.
OFTALE-957; No. of Pages 3
ARTICLE IN PRESS 2
a r c h s o c e s p o f t a l m o l . 2 0 1 6;x x x(x x):xxx–xxx
Discusión: La tolerabilidad endotelial del implante es escasa en casos con edema preexistente, por lo que debe retirarse precozmente. En caso de vitrectomía y afaquia, el mayor riesgo de dislocación de Ozurdex® justifica el recuento endotelial previo. ˜ de Oftalmología. Publicado por Elsevier España, S.L.U. Todos © 2016 Sociedad Espanola los derechos reservados.
Introduction The use of intravitreal steroid implants has changed the clinical management of eye conditions such as diabetic macular oedema, retinal vein occlusion macular oedema as well as non-infectious intermediate and posterior uveitis. In this paper we describe the case of a dexamethasone implant which migrated towards the anterior chamber of an aphakic and vitrectomized patient with persistent secondary corneal dysfunction; a recent complication associated with this therapeutic tool. The drug’s summary of product characteristics does not include information on complications in aphakic patients; hence, we hereby describe a clinical case and its therapeutic approach.
Clinical case A 68-year-old male patient with a history of vitrectomy and a secondary intraocular lens (IOL) implant in the sulcus after experiencing a rupture of the posterior capsule of the OS. After suffering a mild head injury, the patient’s IOL migrated towards the vitreal cavity and had to be removed by means of a pars plana vitrectomy, after which he remained aphakic. Secondarily he also developed a cystoid macular oedema of 670 m refractory to intravitreal injections of triamcinolone (Fig. 1a and b). An Ozurdex® (Allergan Inc., Irvine, CA, USA) implant was consequently placed without complications. A month later the patient presented to the Emergency Department reporting a 3-day history of moderate eye pain, conjunctival hyperaemia and reduced visual acuity in his OS. His intraocular pressure reached levels of up to 35 mmHG and the biomicroscopic examination carried out revealed the presence of the Ozurdex® implant in the anterior chamber causing endothelial contact, folds in Descemet’s membrane, a diffuse corneal oedema and moderate mixed conjunctival hyperaemia (Fig. 2). Timolol (Cusimolol® , Alcon Cusi, Barcelona), brimonidine and Pred Forte® (Allergan Inc, Irvine, CA, EEUU) eye drops were consequently prescribed. Partial removal of the vitreotome was carried out 48 h later under topical anaesthesia and through a perilimbar incision, with the rest of the implant falling into the vitreal cavity. The patient is still being monitored closely 3 months later due to experiencing recurrent episodes of corneal oedema and eye pain resulting from corneal decompensation. His endothelial cell count during the follow-up evaluation that took place 4 months later revealed polymorphism and a cell density of 957 cells/mm2 .
Fig. 1 a and b – Optical coherence tomography revealing a cystoid macular oedema of the OS of 670 m.
Discussion The Ozurdex® implant has proven to be effective in the treatment of both oedematous and non-infectious inflammatory eye disorders. Its safety and efficacy has been proven in pseudophakic and phakic patients with diabetic macular oedema. Prior to its commercialization, Ozurdex® had not been administered to aphakic patients. The summary of product characteristics did not describe complications in this group of patients until 2014 and literally stated that “Ozurdex® must be used with caution in aphakic patients”. Said summary of product characteristics was recently modified in order to include aphakia with damage to the posterior capsule as a contraindication. However, in this paper we describe different risk groups susceptible of assessment and close monitoring prior to its indication.
ARTICLE IN PRESS a r c h s o c e s p o f t a l m o l . 2 0 1 6;x x x(x x):xxx–xxx
3
subclinical endothelial loss due to corneal transparency. Furthermore, both the direct mechanical endothelial contact and the toxicity of dexamethasone at high doses in the anterior chamber could have favoured the decompensation.3 The time spent in the anterior chamber seems to be crucial, in such a way that the longer the delay in removing the implant by means of a surgical procedure, the greater the likelihood of irreversibility of the corneal toxicity.3,4
Conclusion
Fig. 2 – Biomicroscopy of the anterior segment of the left eye showing a diffuse corneal oedema, endothelial folds and an Ozurdex® implant rooted in the lower region of the chamber.
The literature review describes ten cases of migration of Ozurdex® into the anterior chamber.1 We identified the following as risk factors for migration1–3 : a ventral decubitus position, pupillary mydriasis, Yag capsulotomy, prior vitrectomy, aphakia and rupture of the posterior capsule or zonular dehiscence during phacoemulsification. In this particular case, the rupture of the posterior capsule, the vitrectomy and the absence of an anterior vitreous membrane could have facilitated the displacement of the Ozurdex® implant into the anterior chamber. Given the recent commercialization of Ozurdex® , there is insufficient evidence available on the incidence and management of this type of complication. Early removal of the implant from the anterior chamber is essential in cases of corneal oedema. Its repositioning in the posterior chamber seems to be reserved for cases without an associated corneal oedema4 due to the risk of uncontrolled recurrence and of additional endothelial loss. Secondary persistent corneal toxicity has only been described by Malclès et al.3 and Pardo-López et al.,5 who reported a case of refractory corneal oedema which required the conduct of a corneal transplantation. It must be noted that 3 cases published by Malclès et al. report a subclinical loss of endothelial cells detected by specular microscopy after removing the implant. A thorough ultrasound-assisted exploration with a slit lamp can be useful to verify the state of the anterior vitreous membrane. An endothelial cell count is a non-invasive test which we believe must be carried out in patients with a risk factor for migration into the anterior chamber prior to administering the implant. Additionally, pars plana scleral fixation of the Ozurdex® implant should also be considered in this group of risk patients as to prevent its displacement.6 In our case, corneal toxicity was probably multifactorial. Prior surgical procedures could have caused an unreported
The clinical case proves that Ozurdex® can migrate towards the anterior chamber and cause and endothelial oedema in aphakic eyes. The existence of other risk factors for implant migration that could allow for exhaustive monitoring of the patient must be assessed, as well as other first-choice therapeutic alternatives. In case of a suspected subclinical endothelial loss (advanced age, multiple interventions), we believe that both the conduct of an endothelial cell count prior to administering the implant and close clinical monitoring are essential. Corneal toxicity is a major complication that entails a real surgical emergency.
Funding This research work has not received any type of funding source.
Conflict of interest The authors of this paper declare no conflict of interest.
references
1. Laplace O, Rodallec T, Akesbi J, Sandali O. Migration de un implant de dexaméthasone en chambre antérieure chez un patient pseudophaque porteur d’un implant de chambre postérieur suturé à la esclère. J Fr Ophtalmol. 2013;36: e59–61. 2. Jonas JB, Schmidbauer M. Steroid implant in anterior chamber of an aphakic vitrectomized eye. Graefes Arch Clin Exp Ophthalmol. 2013;251:385–6. 3. Malclès A, Janin-Manificat H, Yhuel Y, Russo A, Agard E, El Chehab H, et al. Migration en chamber antérieure de l’implant intravitréen de dexaméthasone Ozurdex® chez le pseudophake: à propos de trios cas. J Fr Ophtalmol. 2013;36: 362–7. 4. Vela JI, Crespi J, Andreu D. Repositioning of dexamethasone intravitreal implant (Ozurdex® ) migrated into the anterior chamber. Int Ophthalmol. 2012;32:583–4. ˜ 5. Pardo-López D, Francés-Munoz E, Gallego-Pinazo R, Díaz-Llopis M. Anterior chamber migration of dexametasone intravitreal implant (Ozurdex® ). Graefes Arch Clin Exp Ophthalmol. 2012;250:1703–4. 6. Mateo C, Alkabes M, Burés-Jelstrup A. Scleral fixation of dexamethasone intravitreal implant (OZURDEX® ) in a case of angle-supported lens implantation. Int Ophthalmol. 2014;34:661–5.
ARCHIVOS DE LA SOCIEDAD ESPAÑOLA DE OFTALMOLOGÍA www.elsevier.es/oftalmologia
Short communication
Corneal toxicity after Ozurdex® migration into anterior chamber夽 L. Bernal ∗ , B. Estévez Servicio de Oftalmología, Complejo Hospitalario Universitario Insular Materno Infantil, Las Palmas de Gran Canaria, Spain
a r t i c l e
i n f o
a b s t r a c t
Article history:
Objective: To describe a case of corneal toxicity after migration of a dexamethasone implant
Received 30 May 2015
into the anterior chamber.
Accepted 12 January 2016
Case report: A 62-year-old man with aphakia and a history of vitrectomy received a dexa-
Available online xxx
methasone implant for a refractory Irvine-Gass syndrome.
Keywords:
contact with secondary corneal oedema that justified the removal of the implant without
Dexamethasone implant
resolution of the oedema.
Thirty days later, the implant migrated into the anterior chamber causing endothelial
Ozurdex®
Discussion: Clinical tolerability to dislocated implant is poor in cases with pre-existing
Migration into anterior chamber
corneal oedema, and because of this, it must be removed early. In cases of aphakia and vit-
Corneal oedema
rectomy, the increased risk of Ozurdex® dislocation justifies performing a prior endothelial count. ˜ © 2016 Sociedad Espanola de Oftalmología. Published by Elsevier España, S.L.U. All rights reserved.
Toxicidad corneal tras migración de Ozurdex® a cámara anterior r e s u m e n Palabras clave:
Objetivo: Presentamos un caso de toxicidad corneal tras migración de un implante de de-
Implante de dexametasona
xametasona (Ozurdex® ) hacia la cámara anterior.
Ozurdex®
˜ Caso clínico: Varón de 62 anos afáquico y vitrectomizado, recibe un implante Ozurdex® por
Migración en cámara anterior
síndrome de Irvine-Gass refractario. Treinta días después el implante migra hacia la cámara
Edema de córnea
anterior produciendo edema corneal por contacto endotelial, que justificó la retirada del dispositivo, sin resolución del edema.
夽 Please cite this article as: Bernal L, Estévez B. Toxicidad corneal tras migración de Ozurdex® a cámara anterior. Arch Soc Esp Oftalmol. 2016. http://dx.doi.org/10.1016/j.oftal.2016.01.008 ∗ Corresponding author. E-mail address: laura [email protected] (L. Bernal). ˜ 2173-5794/© 2016 Sociedad Espanola de Oftalmología. Published by Elsevier España, S.L.U. All rights reserved.
OFTALE-957; No. of Pages 3
ARTICLE IN PRESS 2
a r c h s o c e s p o f t a l m o l . 2 0 1 6;x x x(x x):xxx–xxx
Discusión: La tolerabilidad endotelial del implante es escasa en casos con edema preexistente, por lo que debe retirarse precozmente. En caso de vitrectomía y afaquia, el mayor riesgo de dislocación de Ozurdex® justifica el recuento endotelial previo. ˜ de Oftalmología. Publicado por Elsevier España, S.L.U. Todos © 2016 Sociedad Espanola los derechos reservados.
Introduction The use of intravitreal steroid implants has changed the clinical management of eye conditions such as diabetic macular oedema, retinal vein occlusion macular oedema as well as non-infectious intermediate and posterior uveitis. In this paper we describe the case of a dexamethasone implant which migrated towards the anterior chamber of an aphakic and vitrectomized patient with persistent secondary corneal dysfunction; a recent complication associated with this therapeutic tool. The drug’s summary of product characteristics does not include information on complications in aphakic patients; hence, we hereby describe a clinical case and its therapeutic approach.
Clinical case A 68-year-old male patient with a history of vitrectomy and a secondary intraocular lens (IOL) implant in the sulcus after experiencing a rupture of the posterior capsule of the OS. After suffering a mild head injury, the patient’s IOL migrated towards the vitreal cavity and had to be removed by means of a pars plana vitrectomy, after which he remained aphakic. Secondarily he also developed a cystoid macular oedema of 670 m refractory to intravitreal injections of triamcinolone (Fig. 1a and b). An Ozurdex® (Allergan Inc., Irvine, CA, USA) implant was consequently placed without complications. A month later the patient presented to the Emergency Department reporting a 3-day history of moderate eye pain, conjunctival hyperaemia and reduced visual acuity in his OS. His intraocular pressure reached levels of up to 35 mmHG and the biomicroscopic examination carried out revealed the presence of the Ozurdex® implant in the anterior chamber causing endothelial contact, folds in Descemet’s membrane, a diffuse corneal oedema and moderate mixed conjunctival hyperaemia (Fig. 2). Timolol (Cusimolol® , Alcon Cusi, Barcelona), brimonidine and Pred Forte® (Allergan Inc, Irvine, CA, EEUU) eye drops were consequently prescribed. Partial removal of the vitreotome was carried out 48 h later under topical anaesthesia and through a perilimbar incision, with the rest of the implant falling into the vitreal cavity. The patient is still being monitored closely 3 months later due to experiencing recurrent episodes of corneal oedema and eye pain resulting from corneal decompensation. His endothelial cell count during the follow-up evaluation that took place 4 months later revealed polymorphism and a cell density of 957 cells/mm2 .
Fig. 1 a and b – Optical coherence tomography revealing a cystoid macular oedema of the OS of 670 m.
Discussion The Ozurdex® implant has proven to be effective in the treatment of both oedematous and non-infectious inflammatory eye disorders. Its safety and efficacy has been proven in pseudophakic and phakic patients with diabetic macular oedema. Prior to its commercialization, Ozurdex® had not been administered to aphakic patients. The summary of product characteristics did not describe complications in this group of patients until 2014 and literally stated that “Ozurdex® must be used with caution in aphakic patients”. Said summary of product characteristics was recently modified in order to include aphakia with damage to the posterior capsule as a contraindication. However, in this paper we describe different risk groups susceptible of assessment and close monitoring prior to its indication.
ARTICLE IN PRESS a r c h s o c e s p o f t a l m o l . 2 0 1 6;x x x(x x):xxx–xxx
3
subclinical endothelial loss due to corneal transparency. Furthermore, both the direct mechanical endothelial contact and the toxicity of dexamethasone at high doses in the anterior chamber could have favoured the decompensation.3 The time spent in the anterior chamber seems to be crucial, in such a way that the longer the delay in removing the implant by means of a surgical procedure, the greater the likelihood of irreversibility of the corneal toxicity.3,4
Conclusion
Fig. 2 – Biomicroscopy of the anterior segment of the left eye showing a diffuse corneal oedema, endothelial folds and an Ozurdex® implant rooted in the lower region of the chamber.
The literature review describes ten cases of migration of Ozurdex® into the anterior chamber.1 We identified the following as risk factors for migration1–3 : a ventral decubitus position, pupillary mydriasis, Yag capsulotomy, prior vitrectomy, aphakia and rupture of the posterior capsule or zonular dehiscence during phacoemulsification. In this particular case, the rupture of the posterior capsule, the vitrectomy and the absence of an anterior vitreous membrane could have facilitated the displacement of the Ozurdex® implant into the anterior chamber. Given the recent commercialization of Ozurdex® , there is insufficient evidence available on the incidence and management of this type of complication. Early removal of the implant from the anterior chamber is essential in cases of corneal oedema. Its repositioning in the posterior chamber seems to be reserved for cases without an associated corneal oedema4 due to the risk of uncontrolled recurrence and of additional endothelial loss. Secondary persistent corneal toxicity has only been described by Malclès et al.3 and Pardo-López et al.,5 who reported a case of refractory corneal oedema which required the conduct of a corneal transplantation. It must be noted that 3 cases published by Malclès et al. report a subclinical loss of endothelial cells detected by specular microscopy after removing the implant. A thorough ultrasound-assisted exploration with a slit lamp can be useful to verify the state of the anterior vitreous membrane. An endothelial cell count is a non-invasive test which we believe must be carried out in patients with a risk factor for migration into the anterior chamber prior to administering the implant. Additionally, pars plana scleral fixation of the Ozurdex® implant should also be considered in this group of risk patients as to prevent its displacement.6 In our case, corneal toxicity was probably multifactorial. Prior surgical procedures could have caused an unreported
The clinical case proves that Ozurdex® can migrate towards the anterior chamber and cause and endothelial oedema in aphakic eyes. The existence of other risk factors for implant migration that could allow for exhaustive monitoring of the patient must be assessed, as well as other first-choice therapeutic alternatives. In case of a suspected subclinical endothelial loss (advanced age, multiple interventions), we believe that both the conduct of an endothelial cell count prior to administering the implant and close clinical monitoring are essential. Corneal toxicity is a major complication that entails a real surgical emergency.
Funding This research work has not received any type of funding source.
Conflict of interest The authors of this paper declare no conflict of interest.
references
1. Laplace O, Rodallec T, Akesbi J, Sandali O. Migration de un implant de dexaméthasone en chambre antérieure chez un patient pseudophaque porteur d’un implant de chambre postérieur suturé à la esclère. J Fr Ophtalmol. 2013;36: e59–61. 2. Jonas JB, Schmidbauer M. Steroid implant in anterior chamber of an aphakic vitrectomized eye. Graefes Arch Clin Exp Ophthalmol. 2013;251:385–6. 3. Malclès A, Janin-Manificat H, Yhuel Y, Russo A, Agard E, El Chehab H, et al. Migration en chamber antérieure de l’implant intravitréen de dexaméthasone Ozurdex® chez le pseudophake: à propos de trios cas. J Fr Ophtalmol. 2013;36: 362–7. 4. Vela JI, Crespi J, Andreu D. Repositioning of dexamethasone intravitreal implant (Ozurdex® ) migrated into the anterior chamber. Int Ophthalmol. 2012;32:583–4. ˜ 5. Pardo-López D, Francés-Munoz E, Gallego-Pinazo R, Díaz-Llopis M. Anterior chamber migration of dexametasone intravitreal implant (Ozurdex® ). Graefes Arch Clin Exp Ophthalmol. 2012;250:1703–4. 6. Mateo C, Alkabes M, Burés-Jelstrup A. Scleral fixation of dexamethasone intravitreal implant (OZURDEX® ) in a case of angle-supported lens implantation. Int Ophthalmol. 2014;34:661–5.