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Comparison of DisCoVisc and Hydroxypropylmethylcellulose 2%

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ClinicalTrials.gov Identifier: NCT01387620
Recruitment Status : Completed
First Posted : July 4, 2011
Last Update Posted : July 4, 2011
Information provided by:
University of Sao Paulo

Brief Summary:
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 or disease Intervention/treatment Phase
Corneal Edema Intraocular Pressure Drug: Hyaluronic Acid and hydroxypropylmethylcellulose Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
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
Study Start Date : June 2009
Primary Completion Date : February 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

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

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

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

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

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

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

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 Posted: July 4, 2011    Key Record Dates
Last Update Posted: July 4, 2011
Last Verified: December 2010

Keywords provided by University of Sao Paulo:
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
Protective Agents