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.
Condition: Cataract
MeSH terms: Cataract
Intervention: DisCoVisc®; Healon; Amvisc Plus
Intervention description: Injection of DisCoVisc® Ophthalmic Viscosurgical Device (OVD) into the anterior chamber prior to and throughout the cataract surgery procedure; Injection of Healon into the anterior chamber prior to and throughout the cataract surgery procedure; Injection of Amvisc Plus into the anterior chamber prior to and throughout the cataract surgery procedure
Intervention MeSH terms: Hyaluronic Acid
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 184.0
Sex: All
Minimum age: 49 Years
Healthy volunteers: No
Keywords: Cataract

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