NCT00732225

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2008

Completed
2 years until next milestone

Results Posted

Study results publicly available

July 30, 2010

Completed
Last Updated

July 30, 2010

Status Verified

June 1, 2010

Enrollment Period

9 months

First QC Date

August 7, 2008

Results QC Date

March 31, 2010

Last Update Submit

June 30, 2010

Conditions

Cataracts

Keywords

DisCoVisc OVDOphthalmic Viscosurgical Device

Outcome Measures

Primary Outcomes (1)

  • Percent Loss of Endothelial Cells

    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 Outcomes (7)

  • Aqueous Signs - Corneal Edema

    1 day after surgery

  • Aqueous Signs - Aqueous Flare

    1 day following surgery

  • Aqueous Signs - Aqueous Cells

    1 day following surgery

  • Intraocular Pressure (IOP)

    1 day following surgery

  • Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy

    Time of Surgery

  • +2 more secondary outcomes

Study Arms (5)

DisCoVisc

ACTIVE COMPARATOR

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

Device: DisCoVisc

DuoVisc

ACTIVE COMPARATOR

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

Device: DuoVisc

BioVisc

ACTIVE COMPARATOR

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

Device: BioVisc

Healon5

ACTIVE COMPARATOR

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

Device: Healon5

Amvisc Plus

ACTIVE COMPARATOR

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

Device: Amvisc Plus

Interventions

DisCoViscDEVICE

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

DisCoVisc
DuoViscDEVICE

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.

DuoVisc
BioViscDEVICE

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

BioVisc
Healon5DEVICE

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

Healon5
Amvisc PlusDEVICE

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

Amvisc Plus

Eligibility Criteria

Age49 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral operable cataracts

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Limitations and Caveats

At the time of surgery, patients were assigned to a study group based on the availability of study Ophthalmic Viscosurgical Devices (OVDs).

Results Point of Contact

Title
Alcon Clinical
Organization
Alcon Research, Ltd.
medinfo@alconlabs.com
888.451.3937; 817.568.6725

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 7, 2008

First Posted

August 11, 2008

Study Start

May 1, 2007

Primary Completion

February 1, 2008

Last Updated

July 30, 2010

Results First Posted

July 30, 2010

Record last verified: 2010-06

Locations

US(1)