DisCoVisc Versus DuoVisc, Healon5 and AmVisc Plus

NCT ID: NCT00712244

Last Updated: 2010-09-14

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

PHASE4

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

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 ophthalmic viscosurgical devices (OVDs) (DuoVisc, 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.

Cataract

Study Design

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

Allocation Method

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

Use of DisCoVisc Ophthalmic Viscosurgical Device during cataract surgery.

Group Type ACTIVE_COMPARATOR

DisCoVisc

Intervention Type DEVICE

Use of DisCoVisc Ophthalmic Viscosurgical Device (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery.

DuoVisc

Use of DuoVisc Viscoelastic System (Viscoat, Provisc) during cataract surgery.

Group Type ACTIVE_COMPARATOR

DuoVisc

Intervention Type DEVICE

Use of DuoVisc viscoelastic system consisting of Viscoat (3% sodium hyaluronate, 4% chondroitin sulfate)and Provisc(1% sodium hyaluronate) during cataract surgery.

Healon5

Use of Healon5 ophthalmic viscosurgical device (OVD) during cataract surgery.

Group Type ACTIVE_COMPARATOR

Healon5

Intervention Type DEVICE

Use of Healon5 ophthalmic viscosurgical device (2.3% Sodium Hyaluronate) during cataract surgery.

Amvisc Plus

Use of Amvisc Plus ophthalmic viscosurgical device during cataract surgery.

Group Type ACTIVE_COMPARATOR

Amvisc Plus

Intervention Type DEVICE

Use of Amvisc Plus ophthalmic viscosurgical device (1.6% Sodium Hyaluronate) during cataract surgery.

Interventions

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

DisCoVisc

Use of DisCoVisc Ophthalmic Viscosurgical Device (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery.

Intervention Type DEVICE

DuoVisc

Use of DuoVisc viscoelastic system consisting of Viscoat (3% sodium hyaluronate, 4% chondroitin sulfate)and Provisc(1% sodium hyaluronate) during cataract surgery.

Intervention Type DEVICE

Healon5

Use of Healon5 ophthalmic viscosurgical device (2.3% Sodium Hyaluronate) during cataract surgery.

Intervention Type DEVICE

Amvisc Plus

Use of Amvisc Plus ophthalmic viscosurgical device (1.6% Sodium Hyaluronate) during cataract surgery.

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* operable cataracts in at least one eye

Exclusion Criteria

* Endothelial Cell Count (ECC) ≤1500cells/mm2
* Intraocular Pressure (IOP) \> 21mm Hg
* previous ocular inflammation
* systemic or ocular conditions affecting corneal endothelium
Minimum Eligible Age

50 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

Locations

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

Contact Alcon Call Center for Study 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.

M07-014

Identifier Type: -

Identifier Source: org_study_id