Clinical Evaluation of a New Viscoelastic for Cataract Surgery

Cataract Clinical Trial

Official title:

Clinical Evaluation of a New Viscoelastic for Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972621
• Other study ID #: VSCO-106-DISP
• Status: Completed
• Phase: N/A
• First received: September 3, 2009
• Last updated: February 21, 2018
• Start date: September 2009
• Est. completion date: November 2010

Study information

• Verified date: January 2017
• Source: Abbott Medical Optics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Vitrax II
Viscoelastic administered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber.
• Viscoat
Currently marketed viscoelastic administered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber..

Locations

Country	Name	City	State
United States	AMO Clinical Research Call Center for Trial Locations	Santa Ana	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Optics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively	Cumulative rate of Intraoperative Pressure (IOP) spikes 30 mm Hg (millimeters of mercury) or greater measured postoperatively through three months.	3 months postoperative
Secondary	Postoperative Mean Endothelial Cell Count	mean endothelial cell count (measured by Konan specular microscope) at 3 months	3 months postoperative