Ophthalmologica 2014;232:77–82 DOI: 10.1159/000362178
Received: November 12, 2013 Accepted: March 10, 2014 Published online: July 10, 2014
Long-Term Outcome of an Intravitreal Dexamethasone Implant for the Treatment of Noninfectious Uveitic Macular Edema Zohar Habot-Wilner Nir Sorkin Dafna Goldenberg Anat Loewenstein Michaella Goldstein Department of Ophthalmology, Tel Aviv Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
Key Words Cystoid macular edema · Dexamethasone intravitreal implant · Ozurdex · Spectral domain optical coherence tomography · Uveitis · Uveitic macular edema
Abstract Purpose: To report the long-term outcome of an intravitreal dexamethasone drug delivery system (DEX-DDS) injection for noninfectious uveitic macular edema. Methods: This was a retrospective study of 8 eyes (7 patients). Results: The mean follow-up time was 17.3 months. Macular edema resolved in all eyes at 3.9 weeks (range 1–6.9) postinjection. The central point thickness improved from 612 ± 143 to 250 ± 55 μm (p < 0.05). The mean best corrected visual acuity improved by 0.25 logMAR (p < 0.05) at 3.9 weeks (range 1–6.9) postinjection. In 5 eyes, macular edema did not recur after a mean follow-up of 14.5 months. In 3 eyes, macular edema relapsed after 4.7 months (range 3.6–6.3) and resolved again following further injections. Two eyes developed intraocular pressure elevation, which was well controlled with topical treatment. Conclusions: Intravitreal DEX-DDS injections resulted in resolution of macular edema and visual acuity improvement. Some eyes required repeated injections, but most eyes achieved long-term resolution. No significant complications were noticed. © 2014 S. Karger AG, Basel
© 2014 S. Karger AG, Basel 0030–3755/14/2322–0077$39.50/0 E-Mail [email protected]
Uveitis is one of the main causes of blindness and visual impairment and accounts for up to 25% of legal blindness worldwide [1, 2]. Cystoid macular edema (CME) is the most frequent complication of the disease and has a major role in determining the visual outcome of the patients [1–4]. The mainstay of treatment for uveitis are corticosteroids, which can be administered via a variety of routes, such as topical, periocular, intravitreal, and systemic, depending on the location and severity of the disease. These treatments have different potencies, ocular penetrations, and safety profiles. High doses of systemic corticosteroids are usually required for the treatment of macular edema and may cause severe systemic side effects such as induction or worsening of hypertension, diabetes, osteoporosis, and a Cushingoid state . The use of intravitreal injections allows delivery of therapeutic levels of corticosteroids to the eye while minimizing the systemic exposure. Intravitreal triamcinolone acetonide has been shown to be effective for the control of CME; however, the effect duration, i.e. the resolution or improvement of macular edema, lasts on average 3 months and is commonly associated with local side efZohar Habot-Wilner, MD Department of Ophthalmology, Tel Aviv Medical Center 6 Weizmann Street Tel Aviv 64239 (Israel) E-Mail zwilner @ hotmail.com
fects such as increased intraocular pressure (IOP) and the development or progression of cataract [6–12]. In recent years, significant progress in uveitis treatment has been achieved with the introduction of two intravitreal sustained-release corticosteroid implants: the 0.7-mg dexamethasone drug delivery system (DEXDDS) (Ozurdex®; Allergan Inc., Irvine, Calif., USA) and the sustained-delivery fluocinolone acetonide intravitreal implant (RetisertTM; Bausch and Lomb, Rochester, N.Y., USA). These treatments aim to deliver corticosteroids as sustained-release drugs to the posterior segment for long periods of time and have been approved by the US Food and Drug Administration for the treatment of posterior noninfectious uveitis. Despite the absence of a head-to-head trial comparing the efficacy and safety of the two medications, results obtained from multicenter randomized clinical studies and a comparative case series showed that the 0.7-mg DEX-DDS may have some advantages over the sustained-delivery fluocinolone acetonide intravitreal implant; it is easily injected in an office setting and has significantly fewer local side effects (IOP elevation and cataract formation) following a single injection [13–19]. The prospective multicenter HURON study  showed that both 0.35-mg and 0.7-mg dexamethasone implants significantly reduced macular thickness at 8 and 26 weeks. Two small retrospective case series on intravitreal 0.7mg DEX-DDS injection for noninfectious posterior uveitis have been published to date, and they reported a good treatment effect on macular edema with a safe profile in a short-term follow-up [20, 21]. A recent study showed favorable short-term visual outcomes in vitrectomized eyes with persistent uveitic CME . In the current study, we describe the long-term outcomes of 0.7-mg DEX-DDS intravitreal injections in a series of patients with noninfectious uveitic macular edema.
Methods This retrospective study included 8 eyes of 7 consecutive patients diagnosed with noninfectious uveitic macular edema that were treated with intravitreal 0.7-mg DEX-DDS injection and had at least 6 months of follow-up postinjection. This study was approved by the Tel Aviv Medical Center Review Board and adhered to the tenets of the Declaration of Helsinki for research involving human subjects. All patients underwent a complete ophthalmologic evaluation including: best corrected visual acuity (BCVA), slit lamp examination, fundus examination, fluorescein angiography (FA) (HRA
Ophthalmologica 2014;232:77–82 DOI: 10.1159/000362178
Germany or FF450 plus IR fundus camera; Carl Zeiss Meditec Inc., Jena, Germany), and Heidelberg Spectralis spectral domain optical coherence tomography (SD-OCT) (Heidelberg Engineering, Heidelberg, Germany) at the initial visit. Uveitic macular edema was confirmed by FA and SD-OCT. When the fundus view was impaired and the macular area could not be clearly demonstrated by FA, the macular edema was solely confirmed by SD-OCT. Different types of macular edema were classified according to SD-OCT findings. The macular edema was defined as cystoid (CME) if hyporeflective cystoid spaces were present in the neurosensory retina, or as diffuse if diffuse thickening of the retina was seen without cystoid changes. Foveal subretinal fluid (SRF) was defined as a hyporeflective area underneath the neurosensory retina causing neurosensory retinal elevation. The central point thickness (center point of the fovea) was measured at all visits. Uveitis was graded in accordance with Standardization of Uveitis Nomenclature (SUN) criteria . DEX-DDS injection was administered for unilateral macular edema, or in cases of bilateral disease with asymmetric severity of macular involvement or when the patient declined systemic corticosteroids. Only one patient was treated with systemic immunosuppressive therapy while receiving the DEX-DDS injection, and the dose of the systemic treatment was constant for 10 months prior to the injection. None of the patients had received other intravitreal treatments for uveitic macular edema (intravitreal triamcinolone acetonide or intravitreal avastin injections) at least 6 months prior to treatment with intravitreal DEX-DDS injection. Informed consent was obtained from all patients prior to the injection. Intravitreal injection was performed aseptically after the application of topical anesthesia (lidocaine gel) and 5% povidone iodine to the conjunctival sac. The dexamethasone implant was injected through the pars plana using a 22-gauge applicator device. Patients were treated with topical ofloxacin (Oflox; Allergan Israel) 3 times daily for 5 days following the injection. Repeated ophthalmologic examinations including BCVA, slit lamp examination, fundus examination, Goldmann tonometry, and SD-OCT scans were performed 1 week after the DEX-DDS injection and then at 3- to 6-week intervals during the first year, and thereafter according to the clinical need. In cases where the macular edema and visual acuity (VA) improved following the first injection but recurred during the follow-up, repeated DEX-DDS injections were offered. The equivalent logMAR was calculated and used for analysis. Statistical Analysis Medians were compared using Wilcoxon’s signed rank-sum test. p < 0.05 was considered statistically significant. All analyses were conducted using SAS 9.2 for Windows.
This study included 8 eyes (7 patients; 4 women and 3 men; mean age 38 years, range 22–53). Five patients received a single DEX-DDS injection, 1 patient (case No. 6) received 2 injections in both eyes, and 1 patient (case No. 1) received 4 injections in one eye. The mean follow-up Habot-Wilner et al.
Table 1. Clinical characteristics of the study eyes
Indication for DEX-DDS injection
Systemic Rx at the time of DEX-DDS injection
DEXDDS injection, n
1 2 3 4 5 6 (RE) 6 (LE) 7
53 22 45 26 39 38 38 44
IIU IPAN AU, spondyloarthropathy IIU IIU Pars planitis Pars planitis Ulcerative colitis-related IU
CME and SRF CME and SRF CME CME, SRF, and vitritis CME CME CME and SRF CME and SRF
– – – Cellcept (2 g/day) – – –
4 1 1 1 1 2 2 1
24 15 19 18 17 20 17 8
AU = Anterior uveitis; IU = intermediate uveitis; IIU = idiopathic intermediate uveitis; IPAN = idiopathic panuveitis; LE = left eye; RE = right eye; Rx = treatment.
Table 2. Eyes’ response to dexamethasone implant injection
VA (logMAR) before DEX-DSS injection
Improvement Best postDEX-DDS injection in VA (logMAR) VA (logMAR)
Time to best VA, weeks
Time to macular edema resolution, weeks
Time to macular edema recurrence, months
1 2 3 4 5 6 (RE) 6 (LE) 7
0.52 0.15 0.40 0.7 0.15 0.30 0.22 0.54
0.30 0.10 0.00 0.15 0.00 0.1 0.18 0.15
6.3 6.9 4 4 3 3 3 1
6.3 6.9 4 4 3 3 3 1
3.6 – – – – 4.3 6.3 –
–0.22 –0.05 –0.40 –0.55 –0.15 –0.2 –0.04 –0.39
LE = Left eye; RE = right eye.
time from first DEX-DDS injection was 17.3 months (range 8–24). The clinical characteristics of all eyes are summarized in table 1. Visual Acuity The BCVA significantly improved, from a median (SD) of 0.37 (0.2) logMAR to 0.12 (0.1) logMAR (p < 0.05). The mean (SD) VA improvement following injection was 0.25 (0.18) logMAR. VA improved in all eyes, and 6 out of 8 eyes (75%) improved by 2 or more lines. Of the remaining 2 eyes, 1 had an epiretinal membrane (case No. 2) which may have limited the VA improvement. The mean time to improvement in BCVA following injection was 3.9 weeks (range 1–6.9). Three eyes were reinjected due to recurrence of macular edema (case no. 1: 4 injections; case no. 6: 2 injections in each eye). VA improved in all eyes after the second injection as well; the mean VA Long-Term Outcome of Intravitreal DEXDDS Injection for Uveitic Macular Edema
was 0.33 logMAR prior to the second DEX-DDS injection and it improved to 0.15 logMAR 6 weeks after the injection. One eye (case No. 1), which received a total of 4 injections, demonstrated VA improvement following each injection. The VA results are summarized in table 2. Macular Edema The type of macular edema was classified by SD-OCT; all 8 eyes had CME, and 5 out of 8 eyes [case No.1, 2, 4, 6 (left eye), and 7] had SRF as well. All eyes showed resolution of macular edema after a mean of 3.9 weeks (range 1–6.9) postinjection. The central point thickness improved significantly from a mean (SD) of 612 μm (143) to 250 μm (55) (p < 0.05). Macular edema did not recur in 5 eyes after a mean follow-up of 14.5 months. Macular edema relapsed, with intraretinal cysts but no evidence of SRF, in 3 eyes of 2 patients (case No. 1 and 6) after a mean of 4.7 months Ophthalmologica 2014;232:77–82 DOI: 10.1159/000362178
(range 3.6–6.3). These eyes were retreated with a second injection, and macular edema resolution was achieved. All of these 3 eyes had CME recurrence following the second injection as well after a mean of 5.1 months (range 3.7–7.2), and 1 eye (case No. 1) was further treated with 2 injections. Case No. 6 is a 38-year-old female who had bilateral CME recurrence while pregnant and decided not to be reinjected during the pregnancy. The macular edema measurements are summarized in table 2. Intraocular Inflammation Six eyes had active uveitis in addition to the presence of macular edema; 1 eye had anterior uveitis (case No. 3), 4 eyes had vitritis (cases No. 1, 4, 5, and 7), and 1 eye had both anterior uveitis and vitritis (case No. 2). Among them, 1 eye had a vitreous haze score of more than +1.5 (SUN classification) (case No. 4). DEX-DDS injection resulted in significant improvement of the vitritis in all eyes, with complete resolution by 2 months postinjection. Vitritis did not recur during the follow-up period. Anterior uveitis resolved completely in 2 eyes at 2 weeks postinjection, with no evidence of recurrence. One eye (case No. 5) developed new mild anterior uveitis at 3 months postinjection and was treated with topical corticosteroids resulting in resolution of the anterior uveitis. Dose of Systemic Treatment Case No. 4 received DEX-DDS injection as an adjunctive treatment. The patient had been on a fixed dose of 2 g/day mycophenolate mofetil (Cellcept; Roche) for the past 10 months, when macular edema and vitritis developed. The DEX-DDS injection was administered, resulting in resolution of both the macular edema and the vitritis, with no recurrence during 18 months of follow-up. The long-standing effect DEX-DDS enabled the reduction of the mycophenolate mofetil dosage to 1.5 g/day. Intraocular Pressure One patient (case No. 1) had a corticosteroid-induced raised IOP episode prior to dexamethasone implant injection. That patient received 4 injections. Ten weeks after the second injection, he experienced an IOP increase to 30 mm Hg which normalized with topical timolol + dorzolamide 2 times a day (Cosopt; MSD). A second episode of IOP elevation to 30 mm Hg occurred 8 weeks after the third injection and normalized again with timolol + dorzolamide 2 times a day (Cosopt; MSD). Case No. 7 had an IOP increase to 27 mm Hg 10 weeks after injection, which was well controlled with latanoprost once a day (Xalatan; Pfizer). No change in optic disc appearance was noticed in either patient. 80
Ophthalmologica 2014;232:77–82 DOI: 10.1159/000362178
Other Complications None of the treated eyes developed cataract, retinal tear/detachment, a vitreous hemorrhage, or endophthalmitis after dexamethasone implant injection over the period of follow-up.
This study demonstrated the long-term effect of intravitreal DEX-DDS injection in eyes with noninfectious uveitic macular edema. The treatment is effective and has a favorable safety profile, and in most of the eyes the effect lasted for long periods. In all treated eyes, the macular edema resolved with a significant reduction in central retinal thickness (60% change from baseline) associated with VA improvement. Control of uveitis (anterior uveitis and vitritis) was achieved in all of the patients who had active intraocular inflammation in addition to the presence of macular edema. Following a single injection, most eyes achieved a long CME-free period. No recurrence of anterior uveitis or vitritis was noted during a mean follow-up of 17.3 months. A 26-week phase III trial (the HURON study)  reported the efficacy and safety of either 0.35-mg or 0.7-mg dexamethasone implants compared to sham in the treatment of noninfectious intermediate and posterior uveitis. The main outcome measure was the proportion of eyes with a vitreous haze score of 0 at week 8. This was achieved in 47 and 36% of patients treated with the 0.7-mg or 0.35-mg implant, respectively, compared to 12% of the sham-treated eyes, and it persisted through week 26. In our study, we used the commercially available 0.7-mg DEX-DDS implant and showed a good effect among patients who had active vitritis in addition to macular edema. DEX-DDS injection significantly improved the vitritis in all eyes, with complete resolution 2 months after injection and no recurrence during the follow-up period. In addition, the HURON study  examined the effect of DEX-DDS on macular edema at selected study sites by using OCT to measure the central macular thickness. At weeks 8 and 26, both implant groups had a significantly lower central macular thickness compared to baseline and compared to the sham group. Our study showed that in 5 out of 8 eyes (62.5%) macular edema resolution following a single injection lasted for a mean of 14.5 months. Hence, the effect of DEX-DDS on macular edema resolution may last longer than 26 weeks. Two small short-term retrospective case-series on dexamethasone implant treatment for noninfectious posterior uveitis have been published to date [20, 21]. Habot-Wilner et al.
The first study, by Myung et al. , had a mean followup of 5.25 months. In their series, only 2 eyes (2 patients) had CME which resolved after dexamethasone injection but recurred 4 months after the injection. One patient received a second injection and had no CME relapse at 4 months after the second injection. Our study included 8 eyes of 7 patients, with a significantly longer follow-up of 17.3 months. In our series, all eyes showed an excellent response to dexamethasone injection, with macular edema resolution and VA improvement. A single injection was sufficient for edema resolution in 5 eyes, while in 3 eyes of 2 patients the macular edema relapsed after a mean of 4.7 months. Retreatment with a second dexamethasone injection in all 3 eyes yielded a favorable response similar to that seen after the first injection. All of these 3 eyes had CME recurrence following the second injection after a mean of 5.1 months. One eye received another 2 injections with macular edema resolution. Interestingly, the same 3 eyes that had CME relapse after the first injection relapsed again after the second injection. This might indicate a shorter effect of the dexamethasone implant on some eyes that may need a longer sustained-release corticosteroid drug. Miserocchi et al.  evaluated the use of the dexamethasone implant injection as an adjunctive treatment for recalcitrant noninfectious uveitis. Their study included 10 patients with CME and an inadequate control of uveitis despite different systemic immunosuppressive therapies and/or corticosteroid therapies. The mean follow-up was 9 months postinjection. The VA improved and the central macular thickness decreased postinjection. The reduction in macular thickness was rapid and occurred on average 2 weeks after the injection. One patient was able to reduce the daily corticosteroid dosage after dexamethasone implant injection. There is no data regarding CME relapse in this series. In our study, we used dexamethasone implant injection as an adjunctive treatment in only 1 case (case No.4, case example). The macular edema resolved after the injection and the systemic treatment with mycophenolate mofetil could be reduced. Adán et al.  described the results of dexamethasone implant injections in vitrectomized eyes with persistent CME. The majority of the patients in their series presented with controlled uveitis and most of them were under systemic immunosuppressive treatments. Improvement of the CME was achieved in all eyes after injection. A statistically significant improvement was measured at 1 and 3 months postinjection but was not maintained at 6 months. A median improvement of 1 line of BCVA was achieved at 1 month postinjection, increasing to 2 lines at
3 months, with 52.9% of eyes gaining 2 lines or more. At 6 months, nearly half of those cases (29.4%) maintained the 2-line gain in vision. An increased IOP was found in 47.1% of eyes, and 1 patient required a surgical procedure to control the IOP. One aphakic eye had an anterior chamber displacement of the implant and 1 eye had retinal detachment 5 months after the injection. Comparing those study results to our results, dexamethasone implant injections in vitrectomized eyes might have a shorter treatment effect and higher rates of adverse effects. Our study showed that dexamethasone implant injection has a high safety profile, with only 2 cases of a transient increase in IOP which were well controlled with topical treatment without any damage to the optic nerve. In the series of Myung et al. , none of the eyes showed an increase in IOP. However, in the series of Miserocchi et al. , 3 eyes (25%) had an increase in IOP of less than 30 mm Hg 2 weeks after dexamethasone implant injection, which was controlled with topical antiglaucoma treatment. Cataract formation was not observed in our study. Myung et al.  and Miserocchi et al.  also did not find formation or progression of cataracts at 5 and 9 months of follow-up, respectively. In summary, these data suggests that intravitreal dexamethasone implant injection may offer an effective and safe long-term treatment option for noninfectious uveitic macular edema. The injection is worth considering either as first-line treatment or as an alternative to systemic treatment.
Long-Term Outcome of Intravitreal DEXDDS Injection for Uveitic Macular Edema
Ophthalmologica 2014;232:77–82 DOI: 10.1159/000362178
Disclosure Statement The authors have no sponsorship or funding arrangements related to this research or any possible conflicts of interest.
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