BSSPlus Versus Lactated Ringer's for Phacoemulsification

Cataract Clinical Trial

Official title:

Comparison of Corneal Changes After Phacoemulsification Using BSSPlus Versus Lactated Ringer's Irrigating Solution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801359
• Other study ID #: 8657/2007
• Status: Completed
• Phase: Phase 2
• First received: December 2, 2008
• Last updated: December 15, 2008
• Start date: January 2008
• Est. completion date: October 2008

Study information

• Verified date: December 2008
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• Phacoemulsification

Drug:
• BSSPlus solution

• Lactated Ringer's solution

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto; Centro Avançado de Retina e Catarata	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endothelial cell density		baseline and at 1, 8, 15, 30 and 60 days postoperatively	Yes
Primary	central corneal thickness		baseline and at 1, 8, 15, 30 and 60 days postoperatively	Yes
Secondary	number of anterior chamber cells and flare grade		baseline and at 1, 8, 15, 30 and 60 days postoperatively	Yes