Intraoperative Floppy Iris Syndrome

Alcon

Status and phase: Completed; Phase 4

Conditions: Cataract; Floppy Iris Syndrome

Treatments: Device: DisCoVisc; Device: Healon5

Study type: Interventional

Funder types: Industry

Identifiers

NCT00711347

M07-013

Details and patient eligibility

About

An assessment of the surgical performance of DisCoVisc compared to Healon5 during cataract surgery with intraocular lens implantation where miotic/small pupils or intraoperative Floppy Iris Syndrome exists.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosed with floppy iris syndrome
• operable bilateral cataracts

Exclusion criteria

• Intraocular Pressure (IOP) > 21mmHg
• ocular inflammatory disease
• systemic or ocular diseases affecting Endothelial Cell Count

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

DisCoVisc

Active Comparator group

Description:

Alcon's DisCoVisc Ophthalmic Viscosurgical Device (OVD) used at time of cataract surgery

Treatment:

Device: DisCoVisc

Healon5

Active Comparator group

Description:

Abbott Medical Optic's (AMO) Healon5 Ophthalmic Viscosurgical Device (OVD) used at time of cataract surgery

Treatment:

Device: Healon5