DisCoVisc Comparative Evaluation

Alcon

Status and phase: Completed; Phase 3

Conditions: Cataracts

Treatments: Device: DuoVisc; Device: BioVisc; Device: Amvisc Plus; Device: DisCoVisc; Device: Healon5

Study type: Interventional

Funder types: Industry

Identifiers

NCT00732225

M07-015

Details and patient eligibility

About

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.

Enrollment: 173 patients

Sex: All

Ages: 49+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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173 participants in 5 patient groups

DisCoVisc

Active Comparator group

Description:

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

Treatment:

Device: DisCoVisc

DuoVisc

Active Comparator group

Description:

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

Treatment:

Device: DuoVisc

BioVisc

Active Comparator group

Description:

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

Treatment:

Device: BioVisc

Healon5

Active Comparator group

Description:

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

Treatment:

Device: Healon5

Amvisc Plus

Active Comparator group

Description:

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

Treatment:

Device: Amvisc Plus