Intraoperative dexamethasone intravitreal implant (Ozurdex) in vitrectomy surgery for epiretinal membrane
What:
Paper Presentation | Présentation d'article
Part of:
When:
2:10 PM, Sunday 3 Jun 2018
(10 minutes)
Where:
How:
Authors: Avner Hostovsky, Rajeev H. Muni, Kenneth T. Eng, Drew Drew Mulhall, Christina Leung,
Peter J. Kertes
Author Disclosure Block: A. Hostovsky: None. R.H. Muni: Grant/research support; Allergan. Membership on an advisory panel, standing committee or board of directors; Allergan. K.T. Eng: None. D. Drew Mulhall: None. C. Leung: None. P.J. Kertes: Grant/research support; Allergan, Bayer, Genentech, Janssen, Novartis, Regeneron, Roche. Employment/honoraria/consulting fees; Alcon, Allergan, Bayer, Novartis. Major stock shareholder; ArcticDx. Other financial or material interest; Bayer, Novartis.
Abstract Body:
Purpose: To study of the effectiveness and safety of the intra-operative intravitreal sustained-release dexamethasone implant 0.7mg (Ozurdex®) in vitrectomy surgery for epiretinal membrane
Study Design: Prospective, multicenter, pilot study
Methods: Inclusion criteria included patients with a visually significant (<20/50) idiopathic epiretinal membrane. Exclusion criteria included secondary epiretinal membrane, other visually significant macular pathology and prior intravitreal triamcinolone acetonide. All patients underwent standard 23-gauge pars plana vitrectomy with membrane peeling. At the conclusion of the surgery an Ozurdex implant was injected into the vitreous cavity through the inferotemporal sclerotomy after the cannula had been removed. Patients were followed for 6 months. The primary outcome measure was best corrected visual acuity change at 3 months. Secondary outcomes included best corrected visual acuity change at 6 months, changes in central retinal thickness (CRT) and macular cube volume at 3 and 6 months. Intraocular (IOP) changes were monitored and cataract progression in phakic patients was documented.
Results: 15 patients were enrolled in the study, 2 patients did not meet inclusion criteria and 1 patient was lost to follow up. 12 eyes of 12 patients were included in the analysis. Seven (58%) were phakic and five (42%) were pseudophakic at the time of surgery. Two of the phakic eyes (28%) had worsening of the cataract during the follow-up period and underwent subsequent cataract surgery during the study. Mean preoperative BCVA was 50.67 (SD=8.62) ETDRS letters and improved significantly to 63.67 (+12.91 letters, p=0.008) at three months and to 65.5 (+14.83 letters, p=0.004) at six months. Mean central macular thickness was 548 (SD=97.7) microns at baseline, which improved to 411 microns (-137microns, p=0.002) at 3 months and to 431 microns (-117microns, p=0.001) at 6 months. Mean preoperative macular volume was 12.71 mm3 (SD=1.21) which improved to 10.93 mm3 at 3 months (-1.78mm3, p<0.001) and to 10.99 mm3 at 6 months (-1.72 mm3, p<0.001). There were no complications related to the steroid implant injection procedure in an air filled eye at the end of the surgery. One patient had mild ocular hypertension (IOP<25) at 2 visits that resolved with no treatment. No other complications were documented.
Conclusions: Intra-operative injection of intravitreal dexamethasone implant 0.7mg (Ozurdex) at the end of vitrectomy surgery for epiretinal membrane is a safe technique. The visual acuity outcome is comparable to prior studies with intravitreal triamcinolone acetonide injection at the conclusion of epiretinal membrane surgery with a potentially better safety profile. Dexamethasone intravitreal implant 0.7mg (Ozurdex) is a seemingly useful surgical adjunct that warrants further study.
Author Disclosure Block: A. Hostovsky: None. R.H. Muni: Grant/research support; Allergan. Membership on an advisory panel, standing committee or board of directors; Allergan. K.T. Eng: None. D. Drew Mulhall: None. C. Leung: None. P.J. Kertes: Grant/research support; Allergan, Bayer, Genentech, Janssen, Novartis, Regeneron, Roche. Employment/honoraria/consulting fees; Alcon, Allergan, Bayer, Novartis. Major stock shareholder; ArcticDx. Other financial or material interest; Bayer, Novartis.
Abstract Body:
Purpose: To study of the effectiveness and safety of the intra-operative intravitreal sustained-release dexamethasone implant 0.7mg (Ozurdex®) in vitrectomy surgery for epiretinal membrane
Study Design: Prospective, multicenter, pilot study
Methods: Inclusion criteria included patients with a visually significant (<20/50) idiopathic epiretinal membrane. Exclusion criteria included secondary epiretinal membrane, other visually significant macular pathology and prior intravitreal triamcinolone acetonide. All patients underwent standard 23-gauge pars plana vitrectomy with membrane peeling. At the conclusion of the surgery an Ozurdex implant was injected into the vitreous cavity through the inferotemporal sclerotomy after the cannula had been removed. Patients were followed for 6 months. The primary outcome measure was best corrected visual acuity change at 3 months. Secondary outcomes included best corrected visual acuity change at 6 months, changes in central retinal thickness (CRT) and macular cube volume at 3 and 6 months. Intraocular (IOP) changes were monitored and cataract progression in phakic patients was documented.
Results: 15 patients were enrolled in the study, 2 patients did not meet inclusion criteria and 1 patient was lost to follow up. 12 eyes of 12 patients were included in the analysis. Seven (58%) were phakic and five (42%) were pseudophakic at the time of surgery. Two of the phakic eyes (28%) had worsening of the cataract during the follow-up period and underwent subsequent cataract surgery during the study. Mean preoperative BCVA was 50.67 (SD=8.62) ETDRS letters and improved significantly to 63.67 (+12.91 letters, p=0.008) at three months and to 65.5 (+14.83 letters, p=0.004) at six months. Mean central macular thickness was 548 (SD=97.7) microns at baseline, which improved to 411 microns (-137microns, p=0.002) at 3 months and to 431 microns (-117microns, p=0.001) at 6 months. Mean preoperative macular volume was 12.71 mm3 (SD=1.21) which improved to 10.93 mm3 at 3 months (-1.78mm3, p<0.001) and to 10.99 mm3 at 6 months (-1.72 mm3, p<0.001). There were no complications related to the steroid implant injection procedure in an air filled eye at the end of the surgery. One patient had mild ocular hypertension (IOP<25) at 2 visits that resolved with no treatment. No other complications were documented.
Conclusions: Intra-operative injection of intravitreal dexamethasone implant 0.7mg (Ozurdex) at the end of vitrectomy surgery for epiretinal membrane is a safe technique. The visual acuity outcome is comparable to prior studies with intravitreal triamcinolone acetonide injection at the conclusion of epiretinal membrane surgery with a potentially better safety profile. Dexamethasone intravitreal implant 0.7mg (Ozurdex) is a seemingly useful surgical adjunct that warrants further study.
