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Randomized comparative multicenter study assessing two dispersive viscosurgical devices for cataract surgery.

Ekkehard Fabian1, Andrea Janeková, Pablo de Arriba Palomero

  • 1From the AugenCentrum - Augenklinik Rosenheim, Rosenheim, Germany (Fabian); Eye Centre Prague, Prague, Czech republic (Janeková); Faculty of Medicine, Charles University, Hradec Kralove, Czech Republic (Janeková); Hospital Universitario Ramón y Cajal, Madrid, Spain (de Arriba Palomero); Oftalvist Alicante, Alicante, Spain (Tañá-Rivero); Eye Center, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany (Böhringer); Precise Vision Augenärzte - Augentagesklinik Rheine, Rheine, Germany (Kretz); Premium Clinic Teplice, Teplice, Czech Republic (Pašta); Eye Centre, Prague, Czech Republic (Pašta); Department of Ophthalmology 1st Faculty of Medicine of Charles University and Military University Hospital, Prague, Czech Republic (Pašta); Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, A Coruña, Spain (Touriño-Peralba).

Journal of Cataract and Refractive Surgery
|November 24, 2025
PubMed
Summary

Z-HYALCOAT ophthalmic viscosurgical device (OVD) is non-inferior to HEALON EndoCoat OVD. Both devices demonstrated similar outcomes in intraocular pressure spikes and safety over three months.

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Area of Science:

  • Ophthalmology
  • Medical Devices
  • Clinical Trials

Background:

  • Cataract surgery requires specialized ophthalmic viscosurgical devices (OVDs) to maintain anterior chamber space.
  • Dispersive OVDs are crucial for protecting the corneal endothelium during phacoemulsification.
  • Comparing the efficacy and safety of new OVDs against established ones is essential for clinical practice.

Purpose of the Study:

  • To compare the investigational dispersive ophthalmic viscosurgical device (OVD), Z-HYALCOAT, with the control device, HEALON EndoCoat.
  • To evaluate the non-inferiority of Z-HYALCOAT in managing intraocular pressure (IOP) spikes post-cataract surgery.
  • To assess safety and functionality of both OVDs over a 3-month follow-up period.

Main Methods:

  • A prospective, randomized, masked, multicenter study involving 242 adult subjects undergoing uncomplicated cataract surgery.
  • Subjects received either Z-HYALCOAT or HEALON EndoCoat as the sole OVD.
  • Primary endpoint was the incidence of IOP ≥ 30 mmHg; secondary endpoints included slit lamp findings, corneal endothelial cell density (ECD), and adverse events.

Main Results:

  • No significant difference in IOP spikes (≥ 30 mmHg) between Z-HYALCOAT (11.2%) and HEALON EndoCoat (17.0%) groups at 8 hours post-procedure.
  • Similar outcomes observed in slit lamp examinations and corneal endothelial cell density loss up to 3 months.
  • Surgeon-reported device functionality was comparable and favorable for both OVDs, with similar rates of adverse events and device deficiencies.

Conclusions:

  • Z-HYALCOAT demonstrated non-inferiority to HEALON EndoCoat concerning IOP spikes after cataract surgery.
  • Both ophthalmic viscosurgical devices exhibited comparable safety profiles and clinical performance.
  • The study supports Z-HYALCOAT as a viable alternative dispersive OVD for cataract surgery.