BSSPlus Versus Lactated Ringer's for Phacoemulsification - Full Text View

Sponsored by:	University of Sao Paulo
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00801359

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 II

MedlinePlus related topics: Cataract

Drug Information available for: Ringer's lactate Ringer's solution

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Corneal Changes After Phacoemulsification Using BSSPlus Versus Lactated Ringer's Irrigating Solution

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
BSSplus: Active Comparator	Procedure: Phacoemulsification Drug: BSSPlus solution
Ringer: Experimental	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, São Paulo
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:

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.

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.

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.

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.

Rosenfeld SI, Waltman SR, Olk RJ, Gordon M. Comparison of intraocular irrigating solutions in pars plana vitrectomy. Ophthalmology. 1986 Jan;93(1):109-15.

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

Keywords provided by University of Sao Paulo:

cataract
phacoemulsification
irrigation solution
endothelial cell density
corneal thickness

Study placed in the following topic categories:

Eye Diseases
Cataract
Lens Diseases

Additional relevant MeSH terms:

Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on May 07, 2009