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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00763360
First received: September 26, 2008
Last updated: December 20, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Cataract
Device: DisCoVisc®
Drug: Healon
Drug: Amvisc Plus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
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.

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Endothelial Cell Count Change From Baseline [ Time Frame: one month ] [ Designated as safety issue: Yes ]
    Change in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium.

  • Investigator Reported Space Maintenance [ Time Frame: During surgical procedure ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change in Corneal Thickness [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Change in corneal thickness from baseline, measured in millimeters. Measurement performed by pachymetry.

  • Corneal Clarity [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 184
Study Start Date: May 2008
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DisCoVisc®
DisCoVisc® Ophthalmic Viscosurgical Device
Device: DisCoVisc®
Injection of DisCoVisc® Ophthalmic Viscosurgical Device (OVD) into the anterior chamber prior to and throughout the cataract surgery procedure
Active Comparator: Healon
Healon
Drug: Healon
Injection of Healon into the anterior chamber prior to and throughout the cataract surgery procedure
Active Comparator: Amvisc Plus
Amvisc Plus
Drug: Amvisc Plus
Injection of Amvisc Plus into the anterior chamber prior to and throughout the cataract surgery procedure

  Eligibility

Ages Eligible for Study:   49 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763360

Locations
United States, Texas
Alcon Call Center
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00763360     History of Changes
Other Study ID Numbers: AUS-S-07-01
Study First Received: September 26, 2008
Results First Received: December 20, 2011
Last Updated: December 20, 2011
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Alcon Research:
Cataract

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014