Safety and effectiveness of a new ophthalmic viscosurgical device: randomized, controlled study

Packer, Mark; Berdahl, John P.; Goldberg, Damien F.; Hosten, Lester O; Lau, George

doi:10.1097/j.jcrs.0000000000000904

“…2 Recently, a new U.S. Food and Drug Administration–approved dispersive OVD, ClearVisc (Bausch & Lomb, Inc.), was shown in a randomized controlled multicenter study to be noninferior to the marketed dispersive OVD Viscoat (Alcon Laboratories) in ECD loss and IOP spikes. 27 Malvankar-Mehta et al conducted a meta-analysis of OVD safety outcomes during cataract surgery and concluded that IOP improved when ProVisc and Viscoat were used in combination. 13 Accordingly, it is anticipated that StableVisc with cohesive properties and ClearVisc with dispersive properties will be used in conjunction as a dual system (TotalVisc, Bausch & Lomb, Inc.), yielding even better safety and effectiveness outcomes than either used alone.…”

Section: Discussionmentioning

confidence: 99%

Safety and effectiveness comparison of a new cohesive ophthalmic viscosurgical device

Packer¹,

Shultz²,

Loden³

et al. 2023

J Cataract Refract Surg

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Purpose: To evaluate the safety and effectiveness of a new cohesive ophthalmic viscosurgical device (OVD) (StableVisc) compared with a marketed cohesive OVD (ProVisc) in patients undergoing cataract surgery. Setting: 22 sites in the United States. Design: Prospective multicenter controlled double-masked and randomized 1:1 (StableVisc:ProVisc; stratified by site, age group, and cataract severity). Methods: Adults (≥45 years) with age-related noncomplicated cataract considered amenable to treatment with standard phacoemulsification cataract extraction and intraocular lens implantation were included. Patients were randomized to receive either StableVisc or ProVisc during standard cataract surgery. Postoperative visits occurred at 6 hours, 24 hours, 7 days, 1 month, and 3 months. The primary effectiveness outcome was the change in endothelial cell density (ECD) from baseline to 3 months. The primary safety endpoint was the proportion of patients who experienced at least 1 intraocular pressure (IOP) measurement ≥30 mm Hg at any follow-up visit. Noninferiority between the devices was tested. Inflammation and adverse events were evaluated. Results: 390 patients were randomized; 187 patients with StableVisc and 193 patients with ProVisc completed the study. StableVisc was noninferior to ProVisc in mean ECD loss from baseline to 3 months (17.5% and 16.9%, respectively). StableVisc was noninferior to ProVisc in the proportion of patients with postoperative IOP ≥30 mm Hg at any follow-up visit (5.2% and 8.2%, respectively). Conclusions: The StableVisc cohesive OVD, which provides both mechanical and chemical protection, was safe and effective when used in cataract surgery and provides surgeons with a new cohesive OVD.

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“…We have read with great interest the article by Packer et al and would like to offer critical commentary on the use and analysis of StableVisc OVD (Bausch & Lomb, Inc.). 1 We hope that these perspectives may provide insight into areas that may require further research on the topic and improve subsequent research design.…”

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confidence: 99%

Comment on: Safety and effectiveness comparison of a new cohesive ophthalmic viscosurgical device

Boyle

¹

,

Goodwin

²

2023

J Cataract Refract Surg

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Comment on: Safety and effectiveness comparison of a new cohesive ophthalmic viscosurgical deviceWe have read with great interest the article by Packer et al. and would like to offer critical commentary on the use and analysis of StableVisc OVD (Bausch & Lomb, Inc.). 1 We hope that these perspectives may provide insight into areas that may require further research on the topic and improve subsequent research design.First, there is a discussion of how a surgeon's technique and preferences influence their selection of an ophthalmic viscosurgical device (OVD) and further that this selection may affect the surgery success, postoperative outcome, and patient satisfaction. Then later in the Discussion section, it is noted that the surgeons were only permitted to use a cohesive OVD. We believe this presents a potentially confounding variable. That is, a surgeon's familiarity with cohesive OVDs, without being randomized across groups, could have potentially skewed the data on postoperative outcomes.In addition, the authors report that 77.7% of the patients were White and that 62% were women. This confounding demographic selection could have affected the outcomes of the treatments. According to other studies, there is a potential relationship between race or sex and cataract or refractive surgery outcomes. Two such studies found that women consistently had poorer outcomes and were less satisfied with their vision. 2,3 Another study found that people of different ethnicities had statistically significant variations in the dimensions and position of their lens and capsular bag. 4 As such, the generalizability of the results of Packer et al. could potentially be decreased.Finally, in the "Surgical Procedure and Follow-up" subsection, the authors state that only 1 eye from each patient was used in the study. However, it is not stated how each eye was chosen on each patient and whether the patients had 1 or both eyes operated on using the StableVisc cohesive OVD. This brings into question the internal validity of findings, although this may have just been a mistaken omission.Overall, we applaud the researchers for their interesting new study on a brand new surgical tool. We look forward to seeing this future publication and the effect it could have for the development of new and improved surgical technology and medicine. We believe that with some of these potentially confounding variables addressed, this study could provide great benefit to physicians and their patients. Further highquality studies should be conducted exploring this potentially beneficial cohesive OVD medical tool to further that goal.

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“…The U.S. Food and Drug Administration approved StableVisc on February 22, 2023, to help “prevent tissue damage during surgery, including significant loss of endothelial cells.” 2 StableVisc is part of the TotalVisc system, which also includes the dispersive OVD, ClearVisc. 4 It is anticipated that this dual system may yield even better safety and effectiveness outcomes than either used alone. Future studies are needed to explore the safety and effectiveness of combining these 2 new OVDs.…”

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confidence: 99%

Reply: Safety and effectiveness comparison of a new cohesive ophthalmic viscosurgical device

Packer¹,

Shultz²,

Loden³

et al. 2023

J Cataract Refract Surg

Self Cite

0

View full text Add to dashboard Cite

Comment on: Safety and effectiveness comparison of a new cohesive ophthalmic viscosurgical deviceWe have read with great interest the article by Packer et al. and would like to offer critical commentary on the use and analysis of StableVisc OVD (Bausch & Lomb, Inc.). 1 We hope that these perspectives may provide insight into areas that may require further research on the topic and improve subsequent research design.First, there is a discussion of how a surgeon's technique and preferences influence their selection of an ophthalmic viscosurgical device (OVD) and further that this selection may affect the surgery success, postoperative outcome, and patient satisfaction. Then later in the Discussion section, it is noted that the surgeons were only permitted to use a cohesive OVD. We believe this presents a potentially confounding variable. That is, a surgeon's familiarity with cohesive OVDs, without being randomized across groups, could have potentially skewed the data on postoperative outcomes.In addition, the authors report that 77.7% of the patients were White and that 62% were women. This confounding demographic selection could have affected the outcomes of the treatments. According to other studies, there is a potential relationship between race or sex and cataract or refractive surgery outcomes. Two such studies found that women consistently had poorer outcomes and were less satisfied with their vision. 2,3 Another study found that people of different ethnicities had statistically significant variations in the dimensions and position of their lens and capsular bag. 4 As such, the generalizability of the results of Packer et al. could potentially be decreased.Finally, in the "Surgical Procedure and Follow-up" subsection, the authors state that only 1 eye from each patient was used in the study. However, it is not stated how each eye was chosen on each patient and whether the patients had 1 or both eyes operated on using the StableVisc cohesive OVD. This brings into question the internal validity of findings, although this may have just been a mistaken omission.Overall, we applaud the researchers for their interesting new study on a brand new surgical tool. We look forward to seeing this future publication and the effect it could have for the development of new and improved surgical technology and medicine. We believe that with some of these potentially confounding variables addressed, this study could provide great benefit to physicians and their patients. Further highquality studies should be conducted exploring this potentially beneficial cohesive OVD medical tool to further that goal.

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Safety and effectiveness of a new ophthalmic viscosurgical device: randomized, controlled study

Abstract: To evaluate the safety and effectiveness of a new dispersive ophthalmic viscosurgical device (OVD) (ClearVisc) compared with an approved dispersive OVD (Viscoat) when used in cataract surgery.

Cited by 5 publications

References 19 publications

Safety and effectiveness comparison of a new cohesive ophthalmic viscosurgical device

Safety and effectiveness comparison of a new cohesive ophthalmic viscosurgical device

Comment on: Safety and effectiveness comparison of a new cohesive ophthalmic viscosurgical device

Reply: Safety and effectiveness comparison of a new cohesive ophthalmic viscosurgical device

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