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BSSPlus Versus Lactated Ringer's for Phacoemulsification

This study has been completed.
Information provided by:
University of Sao Paulo Identifier:
First received: December 2, 2008
Last updated: December 15, 2008
Last verified: December 2008
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
Procedure: Phacoemulsification
Drug: BSSPlus solution
Drug: Lactated Ringer's solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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


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

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
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Please refer to this study by its identifier: NCT00801359

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