Intraoperative Floppy Iris Syndrome

NCT ID: NCT00711347

Last Updated: 2010-08-10

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

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-04-30

Brief Summary

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An assessment of the surgical performance of DisCoVisc compared to Healon5 during cataract surgery with intraocular lens implantation where miotic/small pupils or intraoperative Floppy Iris Syndrome exists.

Detailed Description

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Conditions

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Cataract Floppy Iris Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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DisCoVisc

Alcon's DisCoVisc Ophthalmic Viscosurgical Device (OVD) used at time of cataract surgery

Group Type ACTIVE_COMPARATOR

DisCoVisc

Intervention Type DEVICE

Use of Alcon's DisCoVisc Ophthalmic Viscosurgical Device(4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery with intraocular lens implantation.

Healon5

Abbott Medical Optic's (AMO) Healon5 Ophthalmic Viscosurgical Device (OVD) used at time of cataract surgery

Group Type ACTIVE_COMPARATOR

Healon5

Intervention Type DEVICE

Use of Abbott Medical Optics (AMO) Healon5 Ophthalmic Viscosurgical Device (2.3% Sodium Hyaluronate) during cataract surgery with intraocular lens implantation.

Interventions

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DisCoVisc

Use of Alcon's DisCoVisc Ophthalmic Viscosurgical Device(4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery with intraocular lens implantation.

Intervention Type DEVICE

Healon5

Use of Abbott Medical Optics (AMO) Healon5 Ophthalmic Viscosurgical Device (2.3% Sodium Hyaluronate) during cataract surgery with intraocular lens implantation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* diagnosed with floppy iris syndrome
* operable bilateral cataracts

Exclusion Criteria

* Intraocular Pressure (IOP) \> 21mmHg
* ocular inflammatory disease
* systemic or ocular diseases affecting Endothelial Cell Count
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Alcon Laboratories, Inc.

Locations

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Contact Alcon Call Center for Study Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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M07-013

Identifier Type: -

Identifier Source: org_study_id

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