Retrospective Study of Ellipsoid Zone Integrity Following Treatment with Intravitreal Ocriplasmin (OZONE Study)

Kimberly A Drenser,1 Dante J Pieramici,2,3 Joseph M Gunn,4 Daniel F Rosberger,5 Petra Kozma,6 Mitchell S Fineman,7,8 Luc Duchateau,9 Arshad M Khanani10 1Associated Retinal Consultants P.C., Royal Oak, MI, USA; 2California Retina Consultants, Santa Barbara, CA, USA; 3California Retina Research Founda...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Drenser KA, Pieramici DJ, Gunn JM, Rosberger DF, Kozma P, Fineman MS, Duchateau L, Khanani AM
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	symptomatic vitreomacular adhesion vitreomacular traction spectral domain optical coherence tomography macular hole Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/88ad4a67f3f541d9bbc8eb4e4f13ed16
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:88ad4a67f3f541d9bbc8eb4e4f13ed16
record_format	dspace
spelling	oai:doaj.org-article:88ad4a67f3f541d9bbc8eb4e4f13ed162021-12-02T17:55:07ZRetrospective Study of Ellipsoid Zone Integrity Following Treatment with Intravitreal Ocriplasmin (OZONE Study)1177-5483https://doaj.org/article/88ad4a67f3f541d9bbc8eb4e4f13ed162021-07-01T00:00:00Zhttps://www.dovepress.com/retrospective-study-of-ellipsoid-zone-integrity-following-treatment-wi-peer-reviewed-fulltext-article-OPTHhttps://doaj.org/toc/1177-5483Kimberly A Drenser,1 Dante J Pieramici,2,3 Joseph M Gunn,4 Daniel F Rosberger,5 Petra Kozma,6 Mitchell S Fineman,7,8 Luc Duchateau,9 Arshad M Khanani10 1Associated Retinal Consultants P.C., Royal Oak, MI, USA; 2California Retina Consultants, Santa Barbara, CA, USA; 3California Retina Research Foundation, Santa Barbara, CA, USA; 4Southeastern Retina Associates, Kingsport, TN, USA; 5Weill-Cornell Medical College; MaculaCare, PLLC, New York, NY, USA; 6Oxurion NV (formerly ThromboGenics NV), Leuven, Belgium; 7Mid Atlantic Retina, Philadelphia, PA, USA; 8Wills Eye Hospital, Philadelphia, PA, USA; 9Ghent University, Ghent, Belgium; 10Sierra Eye Associates, Reno, NV, USACorrespondence: Kimberly A DrenserAssociated Retinal Consultants P.C., 3555 W 13 Mile Road# LL-20, Royal Oak, MI, 48073, USATel +1 248 288 2280Fax +1 248 288 5644Email kdrenser@arcpc.netPurpose: To assess generalized (GD) and focal ellipsoid zone disruption (FD) in patients with symptomatic vitreomacular adhesion (sVMA) using spectral domain optical coherence tomography (SD-OCT) following ocriplasmin.Patients and methods: OZONE was a Phase 4, retrospective study of patients with sVMA treated with a single intravitreal injection of ocriplasmin (0.125 mg). Data from adult patients with at least 6-month follow-up after ocriplasmin were included. SD-OCT was performed at baseline (within 30 days before ocriplasmin), before Day 21 post-injection (early observation, EO), and by last observation (LO) which was maximally 6 months post-injection. The main outcome measure was the development of new and the evolution of existing FD/GD at EO and LO.Results: The study enrolled 134 eyes/patients from 22 sites in the USA. At baseline, 87 eyes (64.9%) had FD, 21 eyes (15.7%) had GD and 26 eyes (19.4%) had no FD/GD. Among the eyes without FD/GD at baseline, 13 (50%) and 8 (30.8%) developed FD or GD, respectively, by EO. By LO, FD/GD improvement or resolution was seen in > 80% of these eyes. Among the eyes with FD/GD at baseline, < 40% had improving/resolving EZ integrity at LO. The absence of FD/GD at baseline was associated with less persistent FD/GD at LO (P< 0.0005). The presence of FD with MH at baseline was associated with persistent FD at LO (P=0.027).Conclusion: The fact that a large majority of eyes had FD/GD prior to ocriplasmin was unexpected and demonstrates that EZ disruptions are common in sVMA. This suggests that loss of EZ integrity may be part of the natural history of this disorder. It is hypothesized that the status of the EZ at baseline is a contributing, ocriplasmin independent modulator of subsequent EZ changes after ocriplasmin. Prospective analyses which include a sham control group would be required to test this hypothesis.Keywords: symptomatic vitreomacular adhesion, vitreomacular traction, spectral domain optical coherence tomography, macular holeDrenser KAPieramici DJGunn JMRosberger DFKozma PFineman MSDuchateau LKhanani AMDove Medical Pressarticlesymptomatic vitreomacular adhesionvitreomacular tractionspectral domain optical coherence tomographymacular holeOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 15, Pp 3109-3120 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	symptomatic vitreomacular adhesion vitreomacular traction spectral domain optical coherence tomography macular hole Ophthalmology RE1-994
spellingShingle	symptomatic vitreomacular adhesion vitreomacular traction spectral domain optical coherence tomography macular hole Ophthalmology RE1-994 Drenser KA Pieramici DJ Gunn JM Rosberger DF Kozma P Fineman MS Duchateau L Khanani AM Retrospective Study of Ellipsoid Zone Integrity Following Treatment with Intravitreal Ocriplasmin (OZONE Study)
description	Kimberly A Drenser,1 Dante J Pieramici,2,3 Joseph M Gunn,4 Daniel F Rosberger,5 Petra Kozma,6 Mitchell S Fineman,7,8 Luc Duchateau,9 Arshad M Khanani10 1Associated Retinal Consultants P.C., Royal Oak, MI, USA; 2California Retina Consultants, Santa Barbara, CA, USA; 3California Retina Research Foundation, Santa Barbara, CA, USA; 4Southeastern Retina Associates, Kingsport, TN, USA; 5Weill-Cornell Medical College; MaculaCare, PLLC, New York, NY, USA; 6Oxurion NV (formerly ThromboGenics NV), Leuven, Belgium; 7Mid Atlantic Retina, Philadelphia, PA, USA; 8Wills Eye Hospital, Philadelphia, PA, USA; 9Ghent University, Ghent, Belgium; 10Sierra Eye Associates, Reno, NV, USACorrespondence: Kimberly A DrenserAssociated Retinal Consultants P.C., 3555 W 13 Mile Road# LL-20, Royal Oak, MI, 48073, USATel +1 248 288 2280Fax +1 248 288 5644Email kdrenser@arcpc.netPurpose: To assess generalized (GD) and focal ellipsoid zone disruption (FD) in patients with symptomatic vitreomacular adhesion (sVMA) using spectral domain optical coherence tomography (SD-OCT) following ocriplasmin.Patients and methods: OZONE was a Phase 4, retrospective study of patients with sVMA treated with a single intravitreal injection of ocriplasmin (0.125 mg). Data from adult patients with at least 6-month follow-up after ocriplasmin were included. SD-OCT was performed at baseline (within 30 days before ocriplasmin), before Day 21 post-injection (early observation, EO), and by last observation (LO) which was maximally 6 months post-injection. The main outcome measure was the development of new and the evolution of existing FD/GD at EO and LO.Results: The study enrolled 134 eyes/patients from 22 sites in the USA. At baseline, 87 eyes (64.9%) had FD, 21 eyes (15.7%) had GD and 26 eyes (19.4%) had no FD/GD. Among the eyes without FD/GD at baseline, 13 (50%) and 8 (30.8%) developed FD or GD, respectively, by EO. By LO, FD/GD improvement or resolution was seen in > 80% of these eyes. Among the eyes with FD/GD at baseline, < 40% had improving/resolving EZ integrity at LO. The absence of FD/GD at baseline was associated with less persistent FD/GD at LO (P< 0.0005). The presence of FD with MH at baseline was associated with persistent FD at LO (P=0.027).Conclusion: The fact that a large majority of eyes had FD/GD prior to ocriplasmin was unexpected and demonstrates that EZ disruptions are common in sVMA. This suggests that loss of EZ integrity may be part of the natural history of this disorder. It is hypothesized that the status of the EZ at baseline is a contributing, ocriplasmin independent modulator of subsequent EZ changes after ocriplasmin. Prospective analyses which include a sham control group would be required to test this hypothesis.Keywords: symptomatic vitreomacular adhesion, vitreomacular traction, spectral domain optical coherence tomography, macular hole
format	article
author	Drenser KA Pieramici DJ Gunn JM Rosberger DF Kozma P Fineman MS Duchateau L Khanani AM
author_facet	Drenser KA Pieramici DJ Gunn JM Rosberger DF Kozma P Fineman MS Duchateau L Khanani AM
author_sort	Drenser KA
title	Retrospective Study of Ellipsoid Zone Integrity Following Treatment with Intravitreal Ocriplasmin (OZONE Study)
title_short	Retrospective Study of Ellipsoid Zone Integrity Following Treatment with Intravitreal Ocriplasmin (OZONE Study)
title_full	Retrospective Study of Ellipsoid Zone Integrity Following Treatment with Intravitreal Ocriplasmin (OZONE Study)
title_fullStr	Retrospective Study of Ellipsoid Zone Integrity Following Treatment with Intravitreal Ocriplasmin (OZONE Study)
title_full_unstemmed	Retrospective Study of Ellipsoid Zone Integrity Following Treatment with Intravitreal Ocriplasmin (OZONE Study)
title_sort	retrospective study of ellipsoid zone integrity following treatment with intravitreal ocriplasmin (ozone study)
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/88ad4a67f3f541d9bbc8eb4e4f13ed16
work_keys_str_mv	AT drenserka retrospectivestudyofellipsoidzoneintegrityfollowingtreatmentwithintravitrealocriplasminozonestudy AT pieramicidj retrospectivestudyofellipsoidzoneintegrityfollowingtreatmentwithintravitrealocriplasminozonestudy AT gunnjm retrospectivestudyofellipsoidzoneintegrityfollowingtreatmentwithintravitrealocriplasminozonestudy AT rosbergerdf retrospectivestudyofellipsoidzoneintegrityfollowingtreatmentwithintravitrealocriplasminozonestudy AT kozmap retrospectivestudyofellipsoidzoneintegrityfollowingtreatmentwithintravitrealocriplasminozonestudy AT finemanms retrospectivestudyofellipsoidzoneintegrityfollowingtreatmentwithintravitrealocriplasminozonestudy AT duchateaul retrospectivestudyofellipsoidzoneintegrityfollowingtreatmentwithintravitrealocriplasminozonestudy AT khananiam retrospectivestudyofellipsoidzoneintegrityfollowingtreatmentwithintravitrealocriplasminozonestudy
_version_	1718379120523476992

Retrospective Study of Ellipsoid Zone Integrity Following Treatment with Intravitreal Ocriplasmin (OZONE Study)

Ejemplares similares