To Compare the Ability of DiscoVisc® OVD to Protect the Corneal Endothelium and Maintain Anterior Chamber Space With Healon® and Amvisc® PLUS During Cataract Surgery.

Alcon

Status and phase

Completed

Phase 4

Conditions

Cataract

Treatments

Device: DisCoVisc®

Drug: Amvisc Plus

Drug: Healon

Study type

Interventional

Funder types

Industry

Identifiers

NCT00763360

AUS-S-07-01

Details and patient eligibility

About

The objective of the study is to assess how DisCoVisc Ophthalmic Viscosurgical Device (OVD) compares with Healon and Amvisc Plus in the protection of corneal endothelial cells, and the ability to maintain anterior chamber space, in routine cataract surgery.

Enrollment

184 patients

Sex

All

Ages

49+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients able to understand and sign a document of informed consent;
Patients aged ≥49 years with age-related cataract formation;
Patients planning to undergo surgical removal of cataract by phacoemulsification with implantation of a posterior chamber intraocular lens;
Patients that have healthy eyes excluding the formation of cataract.

Exclusion criteria

pseudoexfoliation syndrome with glaucoma or zonular compromise in the operative eye;
A congenital ocular anomaly (e.g., aniridia, congenital cataract) in the operative eye;
Iris atrophy in the operative eye;
Glaucoma (including pseudoexfoliation or pigmentary) or any causes of compromised outflow in the operative eye;
Any abnormality which prevents reliable Goldmann applanation tonometry in the operative eye;
Ocular hypertension (lntraocular Pressure (IOP) > 21 mmHg) in the operative eye at the baseline exam;
Corneal abnormality that results in a poor endothelial cell photograph and prevents reliable endothelial cell density measurement;
Baseline endothelial cell density < 1500 cells/mm2, in the operative eye;
Planned multiple procedures during cataract/Intraocular Lens (IOL) implantation surgery (e.g., trabeculoplasty, corneal transplant). NOTE: A minor relaxing keratotomy
Patients 48 years of age or younger;
Proliferative diabetic retinopathy in the operative eye;
Uncontrolled diabetes mellitus;
Marfan's Syndrome;
An ocular disease and/or condition that may compromise results;
A history of chronic or recurrent inflammatory eye disease (e.g. iritis, scleritis, uveitis, iridocyclitis, rubeosis iritis) in the operative eye;
Lens for the correction of astigmatism may be performed;
Previous ocular trauma to the operative eye (this includes previous intraocular surgery and traumatic cataract). NOTE: history of non-invasive laser surgery (with the exception of laser treatment for PDR) is acceptable for inclusion;
A non-functional fellow eye;
Participation in any other clinical study within the 30 days before surgery