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Comparison of DisCoVisc and Hydroxypropylmethylcellulose 2%

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01387620
First received: June 28, 2011
Last updated: June 30, 2011
Last verified: December 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraindividual Randomized Clinical Comparison of DisCoVisc and Hydroxypropylmethylcellulose 2% in Phacoemulsification

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Corneal endothelial cell count [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Central Corneal Thickness [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01387620

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

No publications provided by University of Sao Paulo

Additional 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
Study First Received: June 28, 2011
Last Updated: June 30, 2011
Health Authority: Brazil: Ministry of Health

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

Additional relevant MeSH terms:
Corneal Edema
Edema
Corneal Diseases
Eye Diseases
Signs and Symptoms
 Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013