NCT02782676

Clinical Investigation of the Bacterially-Derived Healon5 Ophthalmic Viscosurgical Device (OVD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Abbott Medical Optics · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

Prospective, multicenter, paired-eye, randomized, masked, clinical trial of the bacterially-derived Healon5 OVD versus the currently available Healon5 OVD control.

Detailed description

This study will include only subjects undergoing bilateral, primary, cataract extraction and intraocular lens (IOL) implantation and who meet all of the study inclusion and exclusion criteria in both eyes. Subjects who meet the inclusion/exclusion criteria and agree to participate will be randomly assigned to receive the investigational OVD in one eye and the currently-available (i.e., commercial) OVD in the fellow eye (control). Thus, a single group of subjects will provide data for both the investigational OVD and the control OVD.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	Investigational Healon5 OVD	ophthalmic viscosurgical device
DEVICE	Healon5 OVD	ophthalmic viscosurgical device

Timeline

• Start date: 2016-06-21
• Primary completion: 2017-05-04
• Completion: 2017-05-04
• First posted: 2016-05-25
• Last updated: 2025-02-04
• Results posted: 2018-05-24

Regulatory

• FDA-regulated device study