MedDataX Logo

DisCoVisc Comparative Evaluation

NCT ID: NCT00732225

Last Updated: 2010-07-30

Study Results

Results available

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

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A comparison of the ability of DisCoVisc to that of other Opthalmic Viscosurgical Devices (OVDs) (DuoVisc®, BioVisc®, Healon5®, or Amvisc PLUS) regarding endothelial protection and anterior chamber space maintenance during non-eventful cataract surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cataracts

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

DisCoVisc OVD Ophthalmic Viscosurgical Device

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DisCoVisc

Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)

Group Type ACTIVE_COMPARATOR

DisCoVisc

Intervention Type DEVICE

DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.

DuoVisc

Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)

Group Type ACTIVE_COMPARATOR

DuoVisc

Intervention Type DEVICE

DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.

BioVisc

Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)

Group Type ACTIVE_COMPARATOR

BioVisc

Intervention Type DEVICE

BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.

Healon5

AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)

Group Type ACTIVE_COMPARATOR

Healon5

Intervention Type DEVICE

Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.

Amvisc Plus

Bausch \& Lomb Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)

Group Type ACTIVE_COMPARATOR

Amvisc Plus

Intervention Type DEVICE

Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DisCoVisc

DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.

Intervention Type DEVICE

DuoVisc

DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.

Intervention Type DEVICE

BioVisc

BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.

Intervention Type DEVICE

Healon5

Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.

Intervention Type DEVICE

Amvisc Plus

Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Unilateral operable cataracts

Exclusion Criteria

* Preoperative Endothelial Cell Count (ECC) ≤1500 cells/mm2
* Intraocular Pressure (IOP) \> 21
* History of ocular inflammation
* Systemic or ocular diseases affecting corneal endothelium
Minimum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alcon Research

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M07-015

Identifier Type: -

Identifier Source: org_study_id