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BSSPlus Versus Lactated Ringer's for Phacoemulsification

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.
 
ClinicalTrials.gov Identifier: NCT00801359
Recruitment Status : Completed
First Posted : December 3, 2008
Last Update Posted : December 16, 2008
Sponsor:
Information provided by:
University of Sao Paulo

Brief Summary:
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 or disease Intervention/treatment Phase
Cataract Procedure: Phacoemulsification Drug: BSSPlus solution Drug: Lactated Ringer's solution Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
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
Study Start Date : January 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Active Comparator: BSSplus Procedure: Phacoemulsification
Drug: BSSPlus solution
Experimental: Ringer Procedure: Phacoemulsification
Drug: Lactated Ringer's solution



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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

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
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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
Publications:
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Responsible Party: Rodrigo Jorge, University of São Paulo
ClinicalTrials.gov Identifier: NCT00801359    
Other Study ID Numbers: 8657/2007
First Posted: December 3, 2008    Key Record Dates
Last Update Posted: December 16, 2008
Last Verified: December 2008
Keywords provided by University of Sao Paulo:
cataract
phacoemulsification
irrigation solution
endothelial cell density
corneal thickness
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Pharmaceutical Solutions