Back to resultsComparison of DisCoVisc and Hydroxypropylmethylcellulose 2%
Primary Purpose
Corneal Edema, Intraocular Pressure
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Hyaluronic Acid and hydroxypropylmethylcellulose
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Edema focused on measuring Phacoemulsification, Corneal Edema, Corneal Endothelium, Viscoelastic Substances
Eligibility 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
Sites / Locations
- University of São Paulo
Outcomes
Primary Outcome Measures
Corneal endothelial cell count
Secondary Outcome Measures
Central Corneal Thickness
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01387620
Brief Title
Comparison of DisCoVisc and Hydroxypropylmethylcellulose 2%
Official Title
Intraindividual Randomized Clinical Comparison of DisCoVisc and Hydroxypropylmethylcellulose 2% in Phacoemulsification
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Edema, Intraocular Pressure
Keywords
Phacoemulsification, Corneal Edema, Corneal Endothelium, Viscoelastic Substances
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Hyaluronic Acid and hydroxypropylmethylcellulose
Intervention Description
Hyaluronic Acid 1.6% was used to performed phacoemulsification in one eye and hydroxypropylmethylcellulose 2% was used in the fellow eye.
Primary Outcome Measure Information:
Title
Corneal endothelial cell count
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Central Corneal Thickness
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of São Paulo
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
23018304
Citation
Espindola RF, Castro EF, Santhiago MR, Kara-Junior N. A clinical comparison between DisCoVisc and 2% hydroxypropylmethylcellulose in phacoemulsification: a fellow eye study. Clinics (Sao Paulo). 2012 Sep;67(9):1059-62. doi: 10.6061/clinics/2012(09)13.
Results Reference
derived
Learn more about this trial
Comparison of DisCoVisc and Hydroxypropylmethylcellulose 2%
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