Clinical Evaluation of a New Viscoelastic for Cataract Surgery

Abbott

Status: Completed

Conditions: Cataract

Treatments: Device: Viscoat; Device: Vitrax II

Study type: Interventional

Funder types: Industry

Identifiers

NCT00972621

VSCO-106-DISP

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of a new opthalmic viscoelastic material for the use in cataract surgery. The new viscoelastic will be compared to a currently marketed viscoelastic material.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Otherwise healthy eye with no pathology other than the presence of cataract
• Visual potential of 20/40 or better

Exclusion criteria

• Taking any medications that affect vision, intraocular pressure or ease of cataract surgery (e.g. flomax, glaucoma medications, etc.)
• Known intraocular pressure increases from steroid treatment
• Low endothelial cell count

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

400 participants in 2 patient groups

Vitrax II

Experimental group

Description:

Investigational dispersive viscoelastic

Treatment:

Device: Vitrax II

Viscoat

Active Comparator group

Description:

Marketed control dispersive viscoelastic

Treatment:

Device: Viscoat