{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T01:42:02Z","timestamp":1791250922620,"version":"4.1.0"},"reference-count":34,"publisher":"SAGE Publications","issue":"8","license":[{"start":{"date-parts":[[2024,10,1]],"date-time":"2024-10-01T00:00:00Z","timestamp":1727740800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Ocular Pharmacology and Therapeutics"],"published-print":{"date-parts":[[2024,10,1]]},"abstract":"<jats:sec>\n                    <jats:title>Purpose:<\/jats:title>\n                    <jats:p>\n                      To protect the corneal endothelium, various ophthalmical viscoelastic devices (OVDs) are used during cataract surgery. In this study, we compared two sodium hyaluronate-based OVD, the bacteria-derived FIDIAL PLUS OVD (test) with the animal-derived IAL\n                      <jats:sup>\u00ae<\/jats:sup>\n                      -F OVD (reference) during the surgical procedure.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>\n                      Fifty patients with bilateral cataract participated in the study: 50 eyes randomly received FIDIAL PLUS and 50 eyes received IAL\n                      <jats:sup>\u00ae<\/jats:sup>\n                      -F (ratio 1:1). Noninferior efficacy of FIDIAL PLUS compared with reference OVD (first objective) was evaluated using a paired\n                      <jats:italic toggle=\"yes\">t<\/jats:italic>\n                      -test comparing the mean percent loss of corneal endothelial cells (CECs) with FIDIAL PLUS against the mean percent loss with IAL\n                      <jats:sup>\u00ae<\/jats:sup>\n                      -F. Corneal endothelial protection during cataract surgery with FIDIAL PLUS without significant (\u226530 mmHg) postoperative intraocular pressure (IOP) increase (main secondary objective) was assessed using a repeated measures logistic model comparing the incidence of significant postoperative IOP elevation between the two groups. Safety, tolerability, and efficacy were also evaluated by assessing secondary endpoints before and after surgery.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      FIDIAL PLUS showed a statistically noninferior efficacy compared with IAL\n                      <jats:sup>\u00ae<\/jats:sup>\n                      -F; there was no significant increase in IOP in either group or different trends of the secondary endpoints were observed between the OVD groups. The safety profile was similar in both OVD groups and no adverse device effects were reported.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>\n                      This study demonstrates the equivalent efficacy, tolerability, and safety of the bacteria-derived FIDIAL PLUS compared with the animal-derived IAL\n                      <jats:sup>\u00ae<\/jats:sup>\n                      -F, confirming the clinical value of this product.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/jop.2024.0044","type":"journal-article","created":{"date-parts":[[2024,7,1]],"date-time":"2024-07-01T12:04:41Z","timestamp":1719835481000},"page":"469-476","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["A Prospective, Randomized, Controlled Clinical Investigation Comparing the Efficacy and Safety of Sodium Hyaluronate-Based Ophthalmical Viscosurgical Devices FIDIAL PLUS and IAL\n                    <sup>\u00ae<\/sup>\n                    -F in Cataract Surgery"],"prefix":"10.1177","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0866-5683","authenticated-orcid":false,"given":"Camilla","family":"Pagnacco","sequence":"first","affiliation":[{"name":"Department of Surgery, Dentistry, Paediatrics and Gynaecology, Ophthalmology Clinic, University of Verona, Italy."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto","family":"Tosi","sequence":"additional","affiliation":[{"name":"Department of Surgery, Dentistry, Paediatrics and Gynaecology, Ophthalmology Clinic, University of Verona, Italy."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica","family":"Dalsaso","sequence":"additional","affiliation":[{"name":"Department of Surgery, Dentistry, Paediatrics and Gynaecology, Ophthalmology Clinic, University of Verona, Italy."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebastiano","family":"Fraccaroli","sequence":"additional","affiliation":[{"name":"Department of Surgery, Dentistry, Paediatrics and Gynaecology, Ophthalmology Clinic, University of Verona, Italy."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Filippo","family":"Saggin","sequence":"additional","affiliation":[{"name":"Department of Surgery, Dentistry, Paediatrics and Gynaecology, Ophthalmology Clinic, University of Verona, Italy."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giorgio","family":"Marchini","sequence":"additional","affiliation":[{"name":"Department of Surgery, Dentistry, Paediatrics and Gynaecology, Ophthalmology Clinic, University of Verona, Italy."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,10,15]]},"reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/S2214-109X(17)30393-5"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1167\/iovs.15-17201"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1517\/13543784.13.6.691"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)30544-5"},{"issue":"8","key":"e_1_3_4_6_2","first-page":"3523","article-title":"Cataract-related blindness and vision impairment in 2020 and trends over time in relation to VISION 2020: The Right to Sight: An analysis for the Global Burden of Disease Study","volume":"62","author":"Pesudovs K","year":"2021","unstructured":"Pesudovs K, , Lansingh V, , Kempen J, et al. Cataract-related blindness and vision impairment in 2020 and trends over time in relation to VISION 2020: The Right to Sight: An analysis for the Global Burden of Disease Study. Invest Ophthalmol Vis Sci, 2021; 62(8):3523.","journal-title":"Invest Ophthalmol Vis Sci"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(05)70803-5"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1755-3768.2012.02444.x"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.pop.2015.05.012"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2004.11.055"},{"key":"e_1_3_4_11_2","unstructured":"Chang D Davis E Kim T. Improving surgical safety with modern Phaco technology. 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(Eds) Wiley Medical Publishers: New York; 1983; pp. 5-28."},{"key":"e_1_3_4_29_2","doi-asserted-by":"publisher","DOI":"10.1016\/0039-6257(90)90027-S"},{"key":"e_1_3_4_30_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10529-006-9219-z"},{"key":"e_1_3_4_31_2","doi-asserted-by":"crossref","first-page":"8874850","DOI":"10.1155\/2020\/8874850","article-title":"Clinical comparison of the performance of two marketed Ophthalmic Viscoelastic Devices (OVDs): The bacterially derived healon PRO OVD and animal-derived healon OVD","volume":"2020","author":"Daas L","year":"2020","unstructured":"Daas L, , Larrosa JM, , Gavin A, et al. Clinical comparison of the performance of two marketed Ophthalmic Viscoelastic Devices (OVDs): The bacterially derived healon PRO OVD and animal-derived healon OVD. 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