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Comparison of DisCoVisc and Hydroxypropylmethylcellulose 2%

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01387620
First Posted: July 4, 2011
Last Update Posted: July 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Sao Paulo
  Purpose
This prospective study was performed to compare two ophthalmic viscosurgical devices, DisCoVisc (hyaluronic acid 1.6% - chondroitin sulfate 4.0%) and hydroxypropylmethylcellulose 2% in terms of their overall clinical performance during phacoemulsification.

Condition Intervention Phase
Corneal Edema Intraocular Pressure Drug: Hyaluronic Acid and hydroxypropylmethylcellulose Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraindividual Randomized Clinical Comparison of DisCoVisc and Hydroxypropylmethylcellulose 2% in Phacoemulsification

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Corneal endothelial cell count [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Central Corneal Thickness [ Time Frame: 7 days ]

Enrollment: 39
Study Start Date: June 2009
Study Completion Date: December 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Hyaluronic Acid and hydroxypropylmethylcellulose
    Hyaluronic Acid 1.6% was used to performed phacoemulsification in one eye and hydroxypropylmethylcellulose 2% was used in the fellow eye.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bilateral age-related cataract
  • Grade 1-3 lens opacities classification system (LOCS III)
  • Pupil dilatation greater than 7.0 mm

Exclusion Criteria:

  • Black, brunescent, traumatic or subluxated cataract
  • Corneal endothelial disease (endothelial cell count less than 2.000 cells/mm3)
  • Glaucoma, uveitis
  • Previous ocular surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387620


Locations
Brazil
University of São Paulo
São Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rodrigo França de Espíndola, MD, University of Sao Paulo - Fellow
ClinicalTrials.gov Identifier: NCT01387620     History of Changes
Other Study ID Numbers: USP - 0111 - 09
First Submitted: June 28, 2011
First Posted: July 4, 2011
Last Update Posted: July 4, 2011
Last Verified: December 2010

Keywords provided by University of Sao Paulo:
Phacoemulsification
Corneal Edema
Corneal Endothelium
Viscoelastic Substances

Additional relevant MeSH terms:
Corneal Edema
Corneal Diseases
Eye Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents