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BSSPlus Versus Lactated Ringer's for Phacoemulsification

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00801359
First Posted: December 3, 2008
Last Update Posted: December 16, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Sao Paulo
  Purpose
Two intraocular irrigating solutions (BSSPlus versus Lactated Ringer's) are compared in this prospective, randomized, masked trial to investigate for differences in preservation of corneal integrity after phacoemulsification cataract surgery.

Condition Intervention Phase
Cataract Procedure: Phacoemulsification Drug: BSSPlus solution Drug: Lactated Ringer's solution Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Corneal Changes After Phacoemulsification Using BSSPlus Versus Lactated Ringer's Irrigating Solution

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • endothelial cell density [ Time Frame: baseline and at 1, 8, 15, 30 and 60 days postoperatively ]
  • central corneal thickness [ Time Frame: baseline and at 1, 8, 15, 30 and 60 days postoperatively ]

Secondary Outcome Measures:
  • number of anterior chamber cells and flare grade [ Time Frame: baseline and at 1, 8, 15, 30 and 60 days postoperatively ]

Enrollment: 110
Study Start Date: January 2008
Study Completion Date: October 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BSSplus Procedure: Phacoemulsification Drug: BSSPlus solution
Experimental: Ringer Procedure: Phacoemulsification Drug: Lactated Ringer's solution

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with senile cataract
  • Visual acuity between 20/400 and 20/40

Exclusion Criteria:

  • Presence of corneal opacity
  • Presence of corneal disease
  • Traumatic, toxic, hereditary (congenital)and complicated cataracts(uveitis)
  • Anterior chamber cells or flare detected before surgery
  • Previous ocular surgery
  • Any condition which may affect documentation or follow-up
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00801359


Locations
Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto; Centro Avançado de Retina e Catarata
Ribeirão Preto, São Paulo, Brazil, 14049-900
Sponsors and Collaborators
University of Sao Paulo
  More Information