Comparison of DisCoVisc and Hydroxypropylmethylcellulose 2%
Sponsor
University of Sao Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT01387620
Collaborator
(none)
39
1
18
2.2
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
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
:
Jun 1, 2009
Actual Primary Completion Date
:
Feb 1, 2010
Actual Study Completion Date
:
Dec 1, 2010
Outcome Measures
Primary Outcome Measures
- Corneal endothelial cell count [6 months]
Secondary Outcome Measures
- Central Corneal Thickness [7 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
to 90 Years
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of São Paulo | São Paulo | Brazil | 05403-000 |
Sponsors and Collaborators
- University of Sao Paulo
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01387620
Other Study ID Numbers:
- USP - 0111 - 09
First Posted:
Jul 4, 2011
Last Update Posted:
Jul 4, 2011
Last Verified:
Dec 1, 2010
Keywords provided by ,
,
Additional relevant MeSH terms: