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BSSPlus Versus Lactated Ringer's for Phacoemulsification

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00801359
First received: December 2, 2008
Last updated: December 15, 2008
Last verified: December 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Cataract
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
  • central corneal thickness [ Time Frame: baseline and at 1, 8, 15, 30 and 60 days postoperatively ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:

Responsible Party: Rodrigo Jorge, University of São Paulo
ClinicalTrials.gov Identifier: NCT00801359     History of Changes
Other Study ID Numbers: 8657/2007
Study First Received: December 2, 2008
Last Updated: December 15, 2008
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
cataract
phacoemulsification
irrigation solution
endothelial cell density
corneal thickness

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013