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  5. FP528 : Efficacy of Per Operative Ozurdex During Vitrectomy for Epiretinal Membrane

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Dr. Ashish Jain, J20051, Dr. Hardik Jain,
Dr. Navneet Mehrotra, Dr. Manish Nagpal

AIM: To compare outcomes of Pars Plana vitrectomy (PPV) and PPV with intravitreal 0.7mg Dexamethasone implant (OZURDEX) in idiopathic epiretinal membrane (ERM).

METHODS: 41 eyes with idiopathic ERM were divided into 2 subgroups, group A and B. In Group A, 20 eyes underwent PPV and in Group B, 21 eyes underwent PPV with intravitreal OZURDEX. Ophthalmic evaluations included BCVA and CFT preoperatively and at 1 and 3 months postoperatively.

RESULTS: Mean baseline logMAR BCVA in group A improved from 0.685 to 0.526 and CFT improved from 508μ to 395.6μ at 1 month follow up. While in group B, logMAR BCVA improved from 0.657 to 0.476 (p < 0.05) and mean baseline CFT improved from 534.25 μ to 320 μ at 1 month (p < 0.05). BCVA and CFT were maintained at 3 months follow up.

CONCLUSION: This study suggests better functional and anatomical recovery with OZURDEX when combined with vitrectomy in treatment of patients with ERM.

Key words: vitreoretinal surgery, pars plana vitrectomy, Ozurdex, epiretinal membrane

Author: Dr Ashish Jain

Contributing author: Dr Manish Nagpal

Dr Navneet mehrotra

INTRODUCTION:

Pars plana vitrectomy (PPV) with membrane peeling is an established and safe surgical approach for the treatment of idiopathic epiretinal membrane (ERM). However, the procedure is not without risks and has been known to cause postoperative inflammation, hypotony, and changes to the ciliary body, among other adverse events.[1,2] Conventionally, intravitreal triamcinolone (IVTA) is used in PPV to help visualize the vitreous and internal limiting membrane, and it has additionally been shown to be effective in controlling a number of postsurgical complications.[3] One key limit of intravitreal triamcinolone, however, is that it relies partly on the vitreous to act as a drug depot for more sustained release. Studies suggest that clearance of triamcinolone proceeds up to six times more quickly in vitrectomized eyes, as also IVTA injection has its own complications including cataract and glaucoma.[4,5] Given this limitation, dexamethasone implant (Ozurdex, Allergan Inc, Irvine, CA) may be a useful alternative or adjunct to intravitreal triamcinolone. The implant is a free-floating device consisting of a biodegradable polymer matrix that provides sustained release of corticosteroid as it hydrolyzes to carbon dioxide and water. Inserted into the vitreous cavity, Ozurdex is able to release medication for up to 6 months and has been shown to have similar pharmacokinetic profiles in vitrectomized and nonvitrectomized eyes.[6–8] Because the implant undergoes complete dissolution within the vitreous cavity, it may also have distinct advantages over other sustained-release steroid implants using fluocinolone acetonide such as Retisert (Bausch & Lomb, Rochester, NY) and Iluvien (Alimera Sciences, Alpharetta, GA), which contain nonbiodegradable components that remain in the eye, and may require surgical removal as in the case of Retisert. Ozurdex is currently approved for a number of retinal conditions that may require vitrectomy as part of their treatment, including retinal vein occlusion (RVO), noninfectious posterior uveitis, and diabetic macular edema (DME).[9,10] Generally, insertion of the implant is performed as an outpatient office procedure using a single-use applicator to make a transscleral injection. In patients scheduled for PPV for ERM, however, it may be reasonable to also consider concurrent, intraoperative Ozurdex placement for both therapeutic and postsurgical benefit.

In this retrospective cohort study, we investigated the effects of intraoperative Ozurdex injection in patients undergoing pars plana vitrectomy for ERM to determine whether the addition of a gradual-release steroid implant at the time of surgery would be safe and of potential benefit to patients.

MATERIALS AND METHODS:

A retrospective, consecutive, single-center, observational study at a tertiary care academic medical center was conducted. We evaluated all patients undergoing pars plana vitrectomy between April 2014 and May 2017 with or without intraoperative intravitreal Ozurdex implantation in the surgical eye (Group A and B). Patients were evaluated at 1 and 3-month follow-up time points. The primary outcome measure was the best corrected visual acuity (BCVA) and the central foveal thickness (CFT) at 1 and 3 month follow-ups. The presence or absence of complications in the intraoperative and postoperative periods and at subsequent follow-up was also noted. Complications were defined worsening of visual acuity (VA) by 2 lines of vision or more, or increases in intraocular pressure (IOP) by 3 mmHg from the preoperative baseline. Intraocular pressure was measured by Tono-Pen at each visit. The CFT was assessed by optical coherence tomography (OCT, from baseline to the third postoperative month). Descriptive statistics, including frequencies and proportions, were used to analyze patient characteristics and the occurrence of discrete events such as surgical complications, IOP elevations, or increase in CFT. Continuous descriptive statistics (mean, range, standard deviation) were calculated for the magnitudes and changes in VA and IOP. Surgical Technique Vitrectomies were performed with retrobulbar anesthesia under monitored anesthesia care. A caliper was used to mark the sclera 3.0 mm or 3.5 mm posterior to the limbus in pseudophakic and phakic eyes, respectively. Three triplanar wounds—in the inferotemporal, superotemporal, and superonasal quadrants—were created using a single-step 23-gauge or 25-gauge trocar/ cannula microvitrectomy system (Alcon Laboratories Inc, Fort Worth, TX) as previously described. [11] The central core vitreous was removed, and any remaining adherent posterior hyaloid was separated from the retinal surface by suction using a silicone-tipped cannula or the vitreous cutter. Peripheral vitreous was removed with the assistance of scleral depression. The epiretinal membrane was peeled with the help of alcon intraocular forceps. A partial air–fluid exchange was performed with the air infusion set to 25 mmHg, and a complete air–fluid exchange followed by air–gas exchange was performed. Before cannula removal, Ozurdex implant was injected in group B patients at the sclerotomy ports made in all cases. At the conclusion of surgery, cannulas were removed, and any sclerotomy sites shown to be leaking vitreous, gas, or fluid were sutured.

RESULTS

A total of 41 eyes in 41 patients underwent PPV for idiopathic epiretinal membrane. Of these 41, 20 patients put in group A underwent only PPV and 21 eyes underwent PPV with Ozurdex were put in group B.  The mean age among patients was 52.6 years, with a range of 46 years to 83 years. There were 17 women and 24 men. With regard to lens status, 11 eyes were phakic, 18 eyes were pseudophakic, and 11 eyes were having minimal cataract and 1 eye had complicated cataract during the treatment procedure. Follow-up evaluations at 1 and 3 months after surgery were available for all patients. Surgical objectives were achieved in all cases with improvement of visual acuity and decrease in the CFT.

Mean baseline logMAR BCVA in group A improved from 0.685 to 0.526 and CFT improved from 508μ to 395.6μ at 1 month follow up. While in group B, logMAR BCVA improved from 0.657 to 0.476 (p < 0.05) and mean baseline CFT improved from 534.25 μ to 320 μ at 1 month (p < 0.05). BCVA and CFT at 3 months follow up in group A was 0.438 and 386.4 μ and in group B was o.386 and 284.3 μ (p<0.05).

None of the 41 eyes in both groups in the study experienced unexpected intraoperative or postoperative surgical complications. At 3 month postsurgery, 2 eyes in group A as compared to 3 in group B (p>0.05) were noted to have raised intraocular pressures which were medically managed and 1 eye in each group developed cataract which required surgery after 6 month.

DISCUSSION:

Ozurdex has been shown to be safe for a number of underlying conditions that cause macular edema, including diabetic retinopathy, retinal vein occlusion,epiretinal membrane and uveitis. Previous studies have found that in previously vitrectomized eyes, subsequent injection of Ozurdex is not associated with increased risk of adverse events or diminished therapeutic benefit as compared to Ozurdex implantation in nonvitrectomized eyes.8 In this prospective chart review of 41 eyes, we found that addition of intraoperative Ozurdex injection to PPV did not result in unexpected perioperative surgical complications, and overall, appears to stabilize retinal conditions during the postsurgical clinical course in patients with ERM. These findings concur with other complementary studies that show Ozurdex implantation to be safe in combination with anterior segment surgeries such as cataract extraction or intraocular lens removal.[13,14]

However in a study by Guidi et al no significant co relation was seen with preoperative ozurdex for epiretinal membrane at 6 months follow up.[15]

Posterior segment surgeries, and specifically vitrectomy, alter the architecture and environment of the vitreous cavity where Ozurdex is placed and may therefore affect its safety and efficacy profile.

Our results are significant because they suggest that the concurrent, intraoperative use of Ozurdex implant in pars plana vitrectomy is effective and also safe for ERM.

Use of a sustained corticosteroid implant may be especially helpful in postsurgical recovery vitrectomy patients, where the efficacy of conventional intraoperative intravitreal triamcinolone injection may be attenuated. In these cases that we report here, the implant can serve as a source of drug not only for the underlying disease, but also to counteract normal inflammatory and reactive changes after surgery.

CONCLUSION:

Intraoperative sustained-release dexamethasone implant, a powerful antiinflammatory agent with significant efficacy in vitrectomized eyes, results in a significant change in macular thickness and visual gain compared with the vitrectomy alone without dexamethasone implant at 3-month follow-up for patients with epiretinal membrane.

REFERENCES:

  1. Sakamoto T, Miyazaki M, Hisatomi T, et al. Triamcinoloneassisted pars plana vitrectomy improves the surgical procedures and decreases the postoperative blood-ocular barrier breakdown. Graefes Arch Clin Exp Ophthalmol 2002;240: 423–429.
  2. Minamoto A, Nakano KE, Tanimoto S, et al. Ultrasound biomicroscopy in the diagnosis of persistent hypotony after vitrectomy. Am J Ophthalmol 1997;123:711–13.
  3. Lee G, Ahn J, Park Y. Intravitreal triamcinolone reduces the morphologic changes of ciliary body after pars plana vitrectomy for retinal vascular diseases. Am J Ophthalmol 2008;145: 1037–44.
  4. Chin HS, Park TS, Moon YS, Oh JH. Difference in clearance of intravitreal triamcinolone acetonide between vitrectomized and nonvitrectomized eyes. Retina 2005;25:556–60.
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  8. Medeiros MD, Alkabes M, Navarro R, et al. Dexamethasone intravitreal implant in vitrectomized versus nonvitrectomized eyes for treatment of patients with persistent diabetic macular edema. J Ocul Pharmacol Ther 2014;30:709–16.
  9. London NJ, Chiang A, Haller JA. The dexamethasone drug delivery system: indications and evidence. Adv Ther 2011; 28:351–66.
  10. Boyer DS, Yoon YH, Belfort R Jr, et al. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology 2014;121:1904–
  11. Mahajan V, Tarantola R, Graff J, et al. Sutureless triplanar sclerotomy for 23-gauge vitrectomy. Arch Ophthalmol 2011; 129:585–590.
  12. Kuppermann B, Blumenkranz M, Haller J, et al. Randomized controlled study of an Intravitreous dexamethasone drug delivery system in patients with persistent macular edema. Arch Ophthalmol 2007;125:309–17.
  13. Ragam AP, Kolomeyer AM, Nayak NV, Chu DS. The use of Ozurdex (dexamethasone intravitreal implant) during anterior segment surgery in patients with chronic recurrent uveitis. J Ocul Pharmacol Ther 2015;31:344–349.
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  15. . Guidi G,  Casini G, Ripandelli G, Piaggi P et al. RESIDUAL INTRARETINAL EDEMA AFTER 25-GAUGE VITRECTOMY AND MACULAR PUCKER REMOVAL: Is Intraoperative Sustained-release Dexamethasonea Real Treatment Option? Retina. 2017 Apr 3. doi: 10.1097/IAE.0000000000001627.

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