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OpenTrials
Completed

NCT Number: 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.

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.

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Key information

Age range

49 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alcon Call Center

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DisCoVisc®

Device

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

Healon

Drug

Injection of Healon into the anterior chamber prior to and throughout the cataract surgery procedure

Amvisc Plus

Drug

Injection of Amvisc Plus into the anterior chamber prior to and throughout the cataract surgery procedure

Primary outcomes

  1. Endothelial Cell Count Change From Baseline

    Time frame: one month

    Change in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium.

  2. Investigator Reported Space Maintenance

    Time frame: During surgical procedure

    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.

Secondary outcomes

  1. Change in Corneal Thickness

    Time frame: 1 month

    Change in corneal thickness from baseline, measured in millimeters. Measurement performed by pachymetry.

  2. Corneal Clarity

    Time frame: 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2010
First posted
Sep 30, 2008
Registry last updated
Jan 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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