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.

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763360
• Other study ID #: AUS-S-07-01
• Status: Completed
• Phase: Phase 4
• First received: September 26, 2008
• Last updated: December 20, 2011
• Start date: May 2008

Study information

• Verified date: December 2011
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 49 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• DisCoVisc®
Injection of DisCoVisc® Ophthalmic Viscosurgical Device (OVD) into the anterior chamber prior to and throughout the cataract surgery procedure

Drug:
• Healon
Injection of Healon into the anterior chamber prior to and throughout the cataract surgery procedure
• Amvisc Plus
Injection of Amvisc Plus into the anterior chamber prior to and throughout the cataract surgery procedure

Locations

Country	Name	City	State
United States	Alcon Call Center	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Cell Count Change From Baseline	Change in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium.	one month	Yes
Primary	Investigator Reported Space Maintenance	Maintenance of the anterior chamber/dome during cataract surgery. This was rated by the surgeon in one of 4 categories: "Full Chamber Maintained", "Working Space Maintained", "Shallow", "Flat". Space maintenance was reported during Capsulorhexis, Hydrodissection, Phacoemulsification, and IOL insertion.	During surgical procedure	No
Secondary	Change in Corneal Thickness	Change in corneal thickness from baseline, measured in millimeters. Measurement performed by pachymetry.	1 month	No
Secondary	Corneal Clarity	Evaluation of corneal clarity as assessed by levels of aqueous flare and aqueous cells. Evaluations were based on the surgeons judgement and graded on a scale. Aqueous flare was graded on the following scale: No visible flare, mild, moderate, severe. Aqueous cells were graded on the following scale: no cells, 1-20 cells, 10-50 cells, too many cells to count, cells frozen.	2 weeks	Yes