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
  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:


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
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: 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
Corneal Diseases
Eye Diseases
Hyaluronic Acid
Ophthalmic Solutions
Adjuvants, Immunologic
Immunologic Factors
Pharmaceutical Solutions
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses
Viscosupplements

ClinicalTrials.gov processed this record on October 20, 2014