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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 is currently recruiting participants.
Verified by Alcon Research, September 2008
First Received: September 26, 2008   Last Updated: September 29, 2008   History of Changes
Sponsored by: Alcon Research
Information provided by: Alcon Research
ClinicalTrials.gov Identifier: NCT00763360
  Purpose

The objective of the study is to assess how DisCoVisc 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® OVD
Drug: Healon
Drug: Amvisc Plus
Phase IV

Study Type: Interventional
Study Design: Randomized, Single Blind (Outcomes Assessor), Parallel Assignment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • endothelial cell count [ Time Frame: one month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Investigator reported space maintenance [ Time Frame: During surgical procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2008
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
DisCoVisc®
Device: DisCoVisc® OVD
Injection into the anterior chamber prior to and throughout the cataract surgery procedure
2: Active Comparator
Healon
Drug: Healon
Injection into the anterior chamber prior to and throughout the cataract surgery procedure
3: Active Comparator
Amvisc Plus
Drug: Amvisc Plus
Injection 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 (lOP> 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/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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00763360

Contacts
Contact: Alcon Call Center 1-888-451-3937

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

No publications provided

Responsible Party: Alcon Laboratories (Australia) Pty Ltd ( Robert Kitchen, Director of Scientific Affairs )
Study ID Numbers: AUS-S-07-01
Study First Received: September 26, 2008
Last Updated: September 29, 2008
ClinicalTrials.gov Identifier: NCT00763360     History of Changes
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Alcon Research:
Cataract

Study placed in the following topic categories:
Immunologic Factors
Hyaluronic Acid
Eye Diseases
Cataract
Adjuvants, Immunologic
Benzocaine
Lens Diseases

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

ClinicalTrials.gov processed this record on September 11, 2009