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      Short-Term Results of Ocriplasmin versus Prompt Vitrectomy for Macular Hole. Which Performs Better?

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          Abstract

          In this retrospective study, we compared the anatomical and functional changes in patients with vitreomacular traction associated with macular holes between the following groups: (1) Patients who were treated with a single intravitreal injection of ocriplasmin (the OCRIALONE group); (2) those who failed the ocriplasmin treatment and underwent vitrectomy one month later (the OCRIVIT group); and (3) patients who directly underwent par plana vitrectomy (VITREALONE group). A total of 38 patients, 19 in the OCRIALONE group + OCRIVIT group (seven and 12 patients, respectively) and 19 in the VITREALONE group with focal vitreomacular adhesion associated with macular holes were evaluated with spectral domain optical coherence tomography. Functional examinations included best-corrected visual acuity (BCVA) and microperimetry analysis. Visual function changes were compared between the OCRIALONE group + OCRIVIT group and VITREALONE group up to three months. Furthermore, a subgroup analysis compared the OCRIVIT group and the VITREALONE group. BCVA values and the mean retinal sensitivity showed statistically significant improvement in all groups ( p < 0.001). Specifically, the retinal sensitivity values at the end of the follow-up were significantly higher in the OCRIALONE group + OCRIVIT group than in the VITREALONE group. These functional findings were also confirmed when the statistical analysis was conducted between the OCRIVIT group and the VITREALONE group. Although the OCRIALONE group + OCRIVIT group exhibited faster retinal thinning than the VITREALONE group ( p = 0.006), the analysis of the OCRIVIT group versus the VITREALONE group did not show any statistically significant difference. The better functional results and similar anatomical findings suggest that ocriplasmin can be used as a first-line treatment, and that prompt pars plana vitrectomy as primary surgery does not provide better outcomes in comparison with pars plana vitrectomy after ocriplasmin injection.

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          The International Vitreomacular Traction Study Group classification of vitreomacular adhesion, traction, and macular hole.

          Jay Duker, Peter K Kaiser, Susanne Binder … (2013)
          The International Vitreomacular Traction Study (IVTS) Group was convened to develop an optical coherence tomography (OCT)-based anatomic classification system for diseases of the vitreomacular interface (VMI).
          Article 0 comments Cited 326 times – based on 0 reviews     Review now
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            The Lens Opacities Classification System III. The Longitudinal Study of Cataract Study Group.

            Richard I. Bailey, Peter Friend, T Wu … (1993)
            To develop the Lens Opacities Classification System III (LOCS III) to overcome the limitations inherent in lens classification using LOCS II. These limitations include unequal intervals between standards, only one standard for color grading, use of integer grading, and wide 95% tolerance limits. The LOCS III contains an expanded set of standards that were selected from the Longitudinal Study of Cataract slide library at the Center for Clinical Cataract Research, Boston, Mass. It consists of six slit-lamp images for grading nuclear color (NC) and nuclear opalescence (NO), five retroillumination images for grading cortical cataract (C), and five retroillumination images for grading posterior subcapsular (P) cataract. Cataract severity is graded on a decimal scale, and the standards have regularly spaced intervals on a decimal scale. The 95% tolerance limits are reduced from 2.0 for each class with LOCS II to 0.7 for nuclear opalescence, 0.7 for nuclear color, 0.5 for cortical cataract, and 1.0 for posterior subcapsular cataract with the LOCS III, with excellent interobserver agreement. The LOCS III is an improved LOCS system for grading slit-lamp and retroillumination images of age-related cataract.
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              Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes.

              Matthew S Benz, Arnd Gandorfer, S Pakola … (2012)
              Vitreomacular adhesion can lead to pathologic traction and macular hole. The standard treatment for severe, symptomatic vitreomacular adhesion is vitrectomy. Ocriplasmin is a recombinant protease with activity against fibronectin and laminin, components of the vitreoretinal interface. We conducted two multicenter, randomized, double-blind, phase 3 clinical trials to compare a single intravitreal injection of ocriplasmin (125 μg) with a placebo injection in patients with symptomatic vitreomacular adhesion. The primary end point was resolution of vitreomacular adhesion at day 28. Secondary end points were total posterior vitreous detachment and nonsurgical closure of a macular hole at 28 days, avoidance of vitrectomy, and change in best-corrected visual acuity. Overall, 652 eyes were treated: 464 with ocriplasmin and 188 with placebo. Vitreomacular adhesion resolved in 26.5% of ocriplasmin-injected eyes and in 10.1% of placebo-injected eyes (P<0.001). Total posterior vitreous detachment was more prevalent among the eyes treated with ocriplasmin than among those injected with placebo (13.4% vs. 3.7%, P<0.001). Nonsurgical closure of macular holes was achieved in 40.6% of ocriplasmin-injected eyes, as compared with 10.6% of placebo-injected eyes (P<0.001). The best-corrected visual acuity was more likely to improve by a gain of at least three lines on the eye chart with ocriplasmin than with placebo. Ocular adverse events (e.g., vitreous floaters, photopsia, or injection-related eye pain--all self-reported--or conjunctival hemorrhage) occurred in 68.4% of ocriplasmin-injected eyes and in 53.5% of placebo-injected eyes (P<0.001), and the incidence of serious ocular adverse events was similar in the two groups (P=0.26). Intravitreal injection of the vitreolytic agent ocriplasmin resolved vitreomacular traction and closed macular holes in significantly more patients than did injection of placebo and was associated with a higher incidence of ocular adverse events, which were mainly transient. (Funded by ThromboGenics; ClinicalTrials.gov numbers, NCT00781859 and NCT00798317.).
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Clin Med
                Journal ID (iso-abbrev): J Clin Med
                Journal ID (publisher-id): jcm
                Title: Journal of Clinical Medicine
                Publisher: MDPI
                ISSN (Electronic): 2077-0383
                Publication date (Electronic): 07 December 2020
                Publication date Collection: December 2020
                Volume: 9
                Issue: 12
                Electronic Location Identifier: 3972
                Affiliations
                [1 ]IRCCS Fondazione Bietti, 00198 Rome, Italy; pamela.cosimi@ 123456fondazionebietti.it (P.C.); guido.ripandelli@ 123456fondazionebietti.it (G.R.); fabioscarinci@ 123456gmail.com (F.S.)
                [2 ]Department of Medical, Oral and Biotechnological Sciences, “G. d’Annunzio” University, 66100 Chieti, Italy; marta.dinicola@ 123456unich.it
                Author notes
                [* ]Correspondence: andrea_cacciamani@ 123456hotmail.com ; Tel.: +39-068-535-6727; Fax: +39-068-535-2333
                Author information
                https://orcid.org/0000-0003-1748-1931
                https://orcid.org/0000-0001-5444-4377
                Article
                Publisher ID: jcm-09-03972
                DOI: 10.3390/jcm9123972
                PMC ID: 7762417
                PubMed ID: 33297588
                SO-VID: c4e2ed59-60fc-4f09-a531-2dce2080b434
                Copyright © © 2020 by the authors.
                License:

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                Date received : 16 October 2020
                Date accepted : 04 December 2020
                Categories
                Subject: Article

                Keywords: optical coherence tomography,microperimetry,macular hole,ocriplasmin,pars plana vitrectomy,retinal sensitivity,visual acuity
                Data availability:
                Keywords: optical coherence tomography, microperimetry, macular hole, ocriplasmin, pars plana vitrectomy, retinal sensitivity, visual acuity

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