EFFECT OF AN INTRAVITREAL DEXAMETHASONE IMPLANT ON DIABETIC MACULAR EDEMA AFTER CATARACT SURGERY
Pilar Calvo, Antonio Ferreras, Fadwa Al Adel, Wantanee Dangboon, Michael H Brent, Pilar Calvo, Antonio Ferreras, Fadwa Al Adel, Wantanee Dangboon, Michael H Brent
Abstract
Purpose: To analyze the effects of a dexamethasone intravitreal implant (DEX; Ozurdex 700 μg; Allergan) administered immediately after cataract surgery in diabetic patients.
Methods: This prospective, single-arm, open label study (NCT01748487 at ClinicalTrials.gov) involved Type 2 diabetic patients with at least mild diabetic retinopathy (DR) who underwent cataract surgery and DEX insertion after phacoemulsification, and intraocular lens implantation were enrolled. Best-corrected visual acuity and central retinal thickness (CRT) measured by spectral-domain optical coherence tomography were recorded at 1 week preoperatively, and 1 week, 1 month, and 3 months after surgery. Adverse events were also recorded.
Results: Twenty-four eyes of 24 patients (17 [70.8%] men; mean age 63.7 ± 8.7 years) with mild nonproliferative DR (41.7%), moderate nonproliferative DR (33.3%), severe nonproliferative DR (16.7%), or treated proliferative DR (8.3%) were selected. After DEX treatment, mean CRT changed from 241.1 μm (95% confidence interval, 227.5-254.6 μm) at baseline to 236.9 μm (95% confidence interval, 223.9-249.9 μm) at 1 week (P = 0.09), 238.9 μm (95% confidence interval, 225.5-252.3 μm) at 1 month (P = 0.44), and 248 μm (95% confidence interval, 232.4-260.8 μm) at 3 months (P = 0.15). No eyes showed a postoperative increase >50 μm in the CRT at any visit. A 10% increase in CRT was found in 8.3% of eyes. Mean best-corrected visual acuity significantly improved from 0.37 (20/50) at baseline to 0.19 (20/30) at 1 week, 0.12 (20/25) at 1 month, and 0.12 (20/25) at 3 months (P < 0.001 for each comparison). Mean intraocular pressure before surgery was 13.8 mmHg, and none of the patients developed an intraocular pressure ≥22 mmHg at any visit. None of the patients developed any serious adverse events during the follow-up.
Conclusion: These short-term results suggest that a single DEX injection intraoperatively after phacoemulsification could avoid an increase in CRT after cataract surgery in diabetic patients.
Conflict of interest statement
P. Calvo (Lecture fees: Novartis Ophthalmics, Thea; Travel fees: Novartis Ophthalmics, Bayer Healthcare, Alcon Laboratories, Allergan); A. Ferreras (Board Membership: Carl Zeiss Meditec; Lecture fees: Carl Zeiss Meditec; Research support: Oculus, Carl Zeiss Meditec; Travel fees: Novartis Ophthalmics, Bayer Healthcare, Alcon Laboratories, Allergan); M. H. Brent (Board Membership: Novartis Ophthalmics, Bayer Healthcare, Alcon Laboratories; Research support: Novartis Ophthalmics, Allergan). The remaining authors have no financial/conflicting interests to disclose.
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References
- International Diabetes Federation. The IDF Diabetes Atlas. 6th ed Brussels, Belgium: International Diabetes Federation; 2013.
- Klein R, Klein BE, Moss SE, et al. The Wisconsin epidemiologic study of diabetic retinopathy. IV. Diabetic macular edema. Ophthalmology 1984;91:1464–1474.
- Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol 1985;103:1796–1806.
- Treatment techniques and clinical guidelines for photocoagulation of diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 2. Early Treatment Diabetic Retinopathy Study research group. Ophthalmology 1987;94:761–774.
- Arnal E, Miranda M, Almansa I, et al. Lutein prevents cataract development and progression in diabetic rats. Graefes Arch Clin Exp Ophthalmol 2009;247:115–120.
- Chan AW, Ho YS, Chung SK, Chung SS. Synergistic effect of osmotic and oxidative stress in slow-developing cataract formation. Exp Eye Res 2008;87:454–461.
- Kim SJ, Equi R, Bressler NM. Analysis of macular edema after cataract surgery in patients with diabetes using optical coherence tomography. Ophthalmology 2007;114:881–889.
- Jonas JB, Kreissig I, Kamppeter B, Degenring RF. Intravitreal triamcinolone acetonide for the treatment of intraocular edematous and neovascular diseases [in German]. Ophthalmologe 2004;101:113–120.
- Ladjimi A, Zeghidi H, Ben Yahia S, et al. Intravitreal injection of triamcinolone acetonide for the treatment of macular edema [in French]. J Fr Ophthalmol 2005;28:749–757.
- Sorensen TL, Haamann P, Villumsen J, Larsen M. Intravitreal triamcinolone for macular oedema: efficacy in relation to aetiology. Acta Ophthalmol Scand 2005;83:67–70.
- Boscia F, Furino C, Dammacco R, et al. Intravitreal triamcinolone acetonide in refractory pseudophakic cystoid macular edema: functional and anatomic results. Eur J Ophthalmol 2005;15:89–95.
- Elman MJ, Aiello LP, Beck RW, et al. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology 2010;117:1064–1077.
- Nguyen QD, Shah SM, Heier JS, et al. Primary end point (six months) results of the ranibizumab for edema of the macula in diabetes (READ-2) study. Ophthalmology 2009;116:2175–2181.
- Kook D, Wolf A, Kreutzer T, et al. Long-term effect of intravitreal bevacizumab (avastin) in patients with chronic diffuse diabetic macular edema. Retina 2008;28:1053–1060.
- Takamura Y, Kubo E, Akagi Y. Analysis of the effect of intravitreal bevacizumab injection on diabetic macular edema after cataract surgery. Ophthalmology 2009;116:1151–1157.
- Cervera E, Diaz-Llopis M, Udaondo P, Garcia-Delpech S. Intravitreal pegaptanib sodium for refractory pseudophakic macular oedema. Eye (Lond) 2008;22:1180–1182.
- Jeganathan VS, Verma N. Safety and efficacy of intravitreal anti-VEGF injections for age-related macular degeneration. Curr Opin Ophthalmol 2009;20:223–225.
- Simo R, Hernandez C. Intravitreous anti-VEGF for diabetic retinopathy: hopes and fears for a new therapeutic strategy. Diabetologia 2008;51:1574–1580.
- Tezel TH, Kaplan HJ. Are intravitreal anti-VEGF antibodies safe? Ocul Immunol Inflamm 2007;15:1–2.
- Boyer DS, Yoon YH, Belfort R, Jr, et al. ; Ozurdex MEAD Study Group. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology 2014;121:1904–1914.
- Kuppermann BD, Blumenkranz MS, Haller JA, et al. Randomized controlled study of an intravitreous dexamethasone drug delivery system in patients with persistent macular edema. Arch Ophthalmol 2007;125:309–317.
- Chylack LT, Jr, Wolfe JK, Singer DM, et al. The lens Opacities Classification System III. The Longitudinal Study of Cataract Study Group. Arch Ophthalmol 1993;111:831–836.
- Wilkinson CP, Ferris FL, III, Klein RE, et al. Proposed international clinical diabetic retinopathy and diabetic macular edema disease severity scales. Ophthalmology 2003;110:1677–1682.
- Haller JA, Bandello F, Belfort R, Jr, et al. ; OZURDEX GENEVA Study Group. Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology 2010;117:1134–1146.
- Agarwal A, Gupta V, Ram J, Gupta A. Dexamethasone intravitreal implant during phacoemulsication. Ophthalmology 2013;120:211. e1–5.
- Khurana RN, Appa SN, McCannel CA, et al. Dexamethasone implant anterior chamber migration: risk factors, complications, and management strategies. Ophthalmology 2014;121:67–71.
- Sze AM, Luk FO, Yip TP, et al. Use of intravitreal dexamethasone implant in patients with cataract and macular edema undergoing phacoemulsification. Eur J Ophthalmol 2015;25:168–172.
- Khurana RN, Palmer JD, Porco TC, Wieland MR. Dexamethasone intravitreal implant for pseudophakic cystoid macular edema in patients with diabetes. Ophthalmic Surg Lasers Imaging Retina 2015;46:56–61.
- Baker CW, Almukhtar T, Bressler NM, et al. Macular edema after cataract surgery in eyes without preoperative central-involved diabetic macular edema. JAMA Ophthalmol 2013;131:870–879.
- Chu CJ, Johnston RL, Buscombe C, et al. ; United Kingdom Pseudophakic Macular Edema Study Group. Risk factors and incidence of macular edema after cataract surgery: a database study of 81984 eyes. Ophthalmology 2016;123:316–323.
- Romero-Aroca P, Fernández-Ballart J, Almena-Garcia M, et al. Nonproliferative diabetic retinopathy and macular edema progression after phacoemulsification: prospective study. J Cataract Refract Surg 2006;32:1438–1444.
- Yonekawa Y, Kim IK. Pseudophakic cystoid macular edema. Curr Opin Ophthalmol 2012;23:26–32.
- Kim SJ, Jampel H. Prevention of cystoid macular edema after cataract surgery in non-diabetic and diabetic patients: a systematic review and meta-analysis. Am J Ophthalmol 2016;161:221–222.
- Kwak HW, D'Amico DJ. Evaluation of the retinal toxicity and pharmacokinetics of dexamethasone after intravitreal injection. Arch Ophthalmol 1992;110:259–266.
- Chang-Lin JE, Attar M, Acheampong AA, et al. Pharmacokinetics and pharmacodynamics of a sustained-release dexamethasone intravitreal implant. Invest Ophthalmol Vis Sci 2011;52:80–86.
- Chang-Lin JE, Burke JA, Peng Q, et al. Pharmacokinetics of a sustained-release dexamethasone intravitreal implant in vitrectomized and nonvitrectomized eyes. Invest Ophthalmol Vis Sci 2011;52:4605–4609.
- Pleyer U, Ursell P, Rama P. Intraocular pressure effects of common topical steroids for post-cataract inflammation: are they all the same? Ophthalmol Ther 2013;2:55–72.
- Chang DF, Tan JJ, Tripodis Y. Risk factors for steroid response among cataract patients. J Cataract Refract Surg 2011;37:675–681.
Source: PubMed