NCT00972621

Clinical Evaluation of a New Viscoelastic for Cataract Surgery

Completed NA Results posted Last updated 11 February 2025

What this trial tests

NA trial testing Vitrax II in Cataract in 400 participants. Completed in 30 November 2010.

Timeline

30 September 2009

Primary endpoint
30 November 2010

30 November 2010

Quick facts

Lead sponsor	Abbott Medical Optics
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	400
Start date	30 September 2009
Primary completion	30 November 2010
Estimated completion	30 November 2010
Sites	1 location across United States

Drugs / interventions tested

• Vitrax II
• Viscoat — full drug profile →

Conditions studied

• Cataract — all drugs for Cataract →

Sponsor

Abbott Medical Optics

Who can join

18 and older, any sex, with Cataract. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively Primary · 3 months postoperative

Cumulative rate of Intraoperative Pressure (IOP) spikes 30 mm Hg (millimeters of mercury) or greater measured postoperatively through three months.

Group	Value	95% CI
Vitrax II	10.6	6.97 – 14.14
Viscoat	7.6	4.49 – 10.63

Postoperative Mean Endothelial Cell Count Secondary · 3 months postoperative

mean endothelial cell count (measured by Konan specular microscope) at 3 months

Group	Value	95% CI
Vitrax II	2454.3	± 28.87
Viscoat	2366.3	± 33.29

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 4.7%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Vitrax II

Serious: 0/200 (0%)

Deaths: —

Viscoat

Serious: 0/200 (0%)

Deaths: —

Other adverse events (1 terms — click to expand)

Reaction	System	Vitrax II	Viscoat
IOP Spike greater than or equal to 30 mm HG	Eye disorders	—	—

Data from ClinicalTrials.gov NCT00972621 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.