Clinical trial NCT00763360: 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.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: Cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 184
Sex: ALL
Minimum age (years): 49
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Endothelial Cell Count Change From Baseline
timeFrame: one month
measure: Investigator Reported Space Maintenance
timeFrame: During surgical procedure
Secondary outcomes:
measure: Change in Corneal Thickness
timeFrame: 1 month
measure: Corneal Clarity
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center
state: Texas
Study officials:
References: