DisCoVisc Comparative Evaluation

June 30, 2010 updated by: Alcon Research

A Prospective, Non-randomized Comparison of DisCoVisc to Dispersive and Cohesive Ophthalmic Viscosurgical Devices (OVDs) in Non-eventful Cataract Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

173

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Alcon Call Center for Trial Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

49 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DisCoVisc
Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
Device: 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.
Active Comparator: DuoVisc
Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
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.
Active Comparator: BioVisc
Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
Device: BioVisc
BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
Active Comparator: Healon5
AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
Device: Healon5
Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
Active Comparator: Amvisc Plus
Bausch & Lomb Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
Device: Amvisc Plus
Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Loss of Endothelial Cells
Time Frame: 2 months following surgery
Percentage of corneal endothelial cells lost 2 months after surgery as compared to the number of corneal endothelial cells measured before the operation. Corneal Endothelial Cells are measured by counting the number of cells on an image taken by specular microscope.
2 months following surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aqueous Signs - Corneal Edema
Time Frame: 1 day after surgery

Measured as the percentage of patient's eyes subjectively evaluated to have corneal edema at each of the following gradings:

0 - None

  1. - Mild, slight localized or generalized edema
  2. - Moderate, significant localized or generalized edema
  3. - Severe, advanced localized or generalized edema
1 day after surgery
Aqueous Signs - Aqueous Flare
Time Frame: 1 day following surgery

Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Flare at each of the following gradings:

0-None: No visible flare when compared with the normal eye.

  1. Mild: Flare visible against dark papillary background but not visible against iris background.
  2. Moderate: Flare is visible with the slit-lamp beam aimed onto the iris surface as well as the dark papillary background.
  3. Severe: Very dense flare. May also present as a hazy appearance of anterior segment structures when viewed with low power magnification of the slit-lamp.
1 day following surgery
Aqueous Signs - Aqueous Cells
Time Frame: 1 day following surgery

Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Cells at each of the following gradings:

0 - None

  1. - 1 to 5 cells
  2. - 6 to 15 cells
  3. - 16 to 30 cells
  4. - >30 cells
1 day following surgery
Intraocular Pressure (IOP)
Time Frame: 1 day following surgery
Measure of intraocular pressure of a patient's eye via tonometry one day after surgery. Measured in mmHg. Normal intraocular pressure between 10 mmHg and 20 mmHg.
1 day following surgery
Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy
Time Frame: Time of Surgery
Surgeon reporting of Anterior Chamber Dome Maintenance of a patient's eye During Anterior Capsulotomy. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.
Time of Surgery
Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification
Time Frame: Time of Surgery
Surgeon reporting of Anterior Chamber Dome Maintenance of a patient's eye during Phacoemulsification. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance
Time of Surgery
Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion
Time Frame: Time of Surgery
Surgeon reporting of Anterior Chamber Dome Maintenance During Intraocular Lens (IOL) insertion into a patient's eye. Evaluated on a subjective scale and reported as percent by response. The scale, from worst to best, is as follows: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance
Time of Surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

August 7, 2008

First Submitted That Met QC Criteria

August 8, 2008

First Posted (Estimate)

August 11, 2008

Study Record Updates

Last Update Posted (Estimate)

July 30, 2010

Last Update Submitted That Met QC Criteria

June 30, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M07-015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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