DisCoVisc Versus DuoVisc, Healon5 and AmVisc Plus

Alcon

Status and phase: Completed; Phase 4

Conditions: Cataract

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00712244

M07-014

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 4 patient groups

DisCoVisc

Active Comparator group

Description:

Use of DisCoVisc Ophthalmic Viscosurgical Device during cataract surgery.

Treatment:

Device: DisCoVisc

DuoVisc

Active Comparator group

Description:

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

Treatment:

Device: DuoVisc

Healon5

Active Comparator group

Description:

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

Treatment:

Device: Healon5

Amvisc Plus

Active Comparator group

Description:

Use of Amvisc Plus ophthalmic viscosurgical device during cataract surgery.

Treatment:

Device: Amvisc Plus