Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2022 Sep 1;48(9):1050-1056.
doi: 10.1097/j.jcrs.0000000000000904. Epub 2022 Feb 8.

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

Mark Packer  1 , John P Berdahl, Damien F Goldberg, Lester Hosten, George Lau
Affiliations
Randomized Controlled Trial

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

Mark Packer et al. J Cataract Refract Surg. .

Abstract

Purpose: 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.

Setting: 16 clinics in the United States.

Design: Prospective multicenter controlled randomized 1:1 (ClearVisc:Viscoat; stratified by site, age group, and cataract severity). Patients and examiners masked.

Methods: Patients aged 45 years or older with age-related noncomplicated cataract considered amenable to treatment with standard phacoemulsification cataract extraction and intraocular lens (IOL) implantation were included. Patients were randomized to receive either ClearVisc or Viscoat using standard techniques. 5 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 end point was the proportion of patients who experienced at least 1 intraocular pressure (IOP) measurement ≥30 mm Hg at any follow-up visit. Noninferiority was tested. Inflammation and adverse events were evaluated.

Results: 372 patients were randomized: 184 patients in the ClearVisc group and 188 patients in the Viscoat group. ClearVisc was noninferior to Viscoat in mean percentage of ECD loss from baseline to 3 months (8.4% and 6.8%, respectively). ClearVisc was significantly noninferior to Viscoat in the proportion of patients with postoperative IOP ≥30 mm Hg at any follow-up visit (17.4% and 20.3%, respectively, P = .0002).

Conclusions: ClearVisc dispersive OVD provides surgeons with a new option in the continuum of approved dispersive OVDs with beneficial properties as a surgical aid in cataract extraction and IOL implantation.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Mean loss of endothelial cell density (cells/mm2) from baseline to 3 months: intent-to-treat population. The 1.6% difference in percent loss met noninferiority criteria.
Figure 2.
Figure 2.
Mean IOP (mm Hg) over time: safety population. Superiority criterion was not met.
See this image and copyright information in PMC

References

    1. Takahashi H. Corneal endothelium and phacoemulsification. Cornea 2016;35(suppl 1):S3–S7 - PubMed
    1. Maugeri F, Maltese A, Ward KW, Bucolo C. Hydroxyl radical scavenging activity of a new ophthalmic viscosurgical device. Curr Eye Res 2007;32:105–111 - PubMed
    1. Holst A, Rolfsen W, Svensson B, Ollinger K, Lundgren B. Formation of free radicals during phacoemulsification. Curr Eye Res 1993;12:359–365 - PubMed
    1. Rubowitz A, Assia EI, Rosner M, Topaz M. Antioxidant protection against corneal damage by free radicals during phacoemulsification. Invest Ophthalmol Vis Sci 2003;44:1866–1870 - PubMed
    1. Takahashi H. Free radical development in phacoemulsification cataract surgery. J Nippon Med Sch 2005;72:4–12 - PubMed

Publication types