Clinical Evaluation of a New Viscoelastic for Cataract Surgery

NCT ID: NCT00972621

Last Updated: 2025-02-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Vitrax II

Investigational dispersive viscoelastic

Group Type EXPERIMENTAL

Vitrax II

Intervention Type DEVICE

Viscoelastic administered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber.

Viscoat

Marketed control dispersive viscoelastic

Group Type ACTIVE_COMPARATOR

Viscoat

Intervention Type DEVICE

Currently marketed viscoelastic administered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber..

Interventions

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Vitrax II

Viscoelastic administered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber.

Intervention Type DEVICE

Viscoat

Currently marketed viscoelastic administered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber..

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Optics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AMO Clinical Research Call Center for Trial Locations

Santa Ana, California, United States

Site Status

Countries

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United States

Other Identifiers

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VSCO-106-DISP

Identifier Type: -

Identifier Source: org_study_id

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