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
  • Drug: Hyaluronic Acid and hydroxypropylmethylcellulose
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

  1. Corneal endothelial cell count [6 months]

Secondary Outcome Measures

  1. 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

Study Results

No Results Posted as of Jul 4, 2011