Back to resultsBSSPlus Versus Lactated Ringer's for Phacoemulsification
Primary Purpose
Cataract
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Phacoemulsification
BSSPlus solution
Lactated Ringer's solution
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring cataract, phacoemulsification, irrigation solution, endothelial cell density, corneal thickness
Eligibility 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
Sites / Locations
- Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto; Centro Avançado de Retina e Catarata
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
BSSplus
Ringer
Arm Description
Outcomes
Primary Outcome Measures
endothelial cell density
central corneal thickness
Secondary Outcome Measures
number of anterior chamber cells and flare grade
Full Information
NCT ID
NCT00801359
First Posted
December 2, 2008
Last Updated
December 15, 2008
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00801359
Brief Title
BSSPlus Versus Lactated Ringer's for Phacoemulsification
Official Title
Comparison of Corneal Changes After Phacoemulsification Using BSSPlus Versus Lactated Ringer's Irrigating Solution
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
cataract, phacoemulsification, irrigation solution, endothelial cell density, corneal thickness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BSSplus
Arm Type
Active Comparator
Arm Title
Ringer
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Phacoemulsification
Intervention Type
Drug
Intervention Name(s)
BSSPlus solution
Intervention Type
Drug
Intervention Name(s)
Lactated Ringer's solution
Primary Outcome Measure Information:
Title
endothelial cell density
Time Frame
baseline and at 1, 8, 15, 30 and 60 days postoperatively
Title
central corneal thickness
Time Frame
baseline and at 1, 8, 15, 30 and 60 days postoperatively
Secondary Outcome Measure Information:
Title
number of anterior chamber cells and flare grade
Time Frame
baseline and at 1, 8, 15, 30 and 60 days postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto; Centro Avançado de Retina e Catarata
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
7862416
Citation
Puckett TR, Peele KA, Howard RS, Kramer KK. Intraocular irrigating solutions. A randomized clinical trial of balanced salt solution plus and dextrose bicarbonate lactated Ringer's solution. Ophthalmology. 1995 Feb;102(2):291-6. doi: 10.1016/s0161-6420(95)31026-3.
Results Reference
background
PubMed Identifier
931689
Citation
McCarey BE, Polack FM, Marshall W. The phacoemulsification procedure. I. The effect of intraocular irrigating solutions on the corneal endothelium. Invest Ophthalmol. 1976 Jun;15(6):449-57.
Results Reference
background
PubMed Identifier
10713235
Citation
Joussen AM, Barth U, Cubuk H, Koch H. Effect of irrigating solution and irrigation temperature on the cornea and pupil during phacoemulsification. J Cataract Refract Surg. 2000 Mar;26(3):392-7. doi: 10.1016/s0886-3350(99)00470-8.
Results Reference
background
PubMed Identifier
5636786
Citation
Kaye GI, Mishima S, Cole JD, Kaye NW. Studies on the cornea. VII. Effects of perfusion with a Ca++-free medium on the corneal endothelium. Invest Ophthalmol. 1968 Feb;7(1):53-66. No abstract available.
Results Reference
background
PubMed Identifier
3513079
Citation
Rosenfeld SI, Waltman SR, Olk RJ, Gordon M. Comparison of intraocular irrigating solutions in pars plana vitrectomy. Ophthalmology. 1986 Jan;93(1):109-15. doi: 10.1016/s0161-6420(86)33790-4.
Results Reference
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BSSPlus Versus Lactated Ringer's for Phacoemulsification
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