BSSPlus Versus Lactated Ringer's for Phacoemulsification

Phase 2

Completed

• Conditions: Cataract
• Interventions: Procedure: Phacoemulsification; Drug: BSSPlus solution; Drug: Lactated Ringer's solution

• Registration Number: NCT00801359
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-08
• Study Completion: 2008-10
• Status Verified: 2008-12
• Study First Submitted: 2008-12-02
• Study First Submitted QC: 2008-12-02
• Study First Posted: 2008-12-03
• Last Update Submitted: 2008-12-15
• Last Update Posted: 2008-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BSSplus	BSSPlus solution	-
Ringer	Phacoemulsification	-
BSSplus	Phacoemulsification	-
Ringer	Lactated Ringer's solution	-

Primary Outcome Measures

Name	Time	Method
endothelial cell density	baseline and at 1, 8, 15, 30 and 60 days postoperatively
central corneal thickness	baseline and at 1, 8, 15, 30 and 60 days postoperatively

Secondary Outcome Measures

Name	Time	Method
number of anterior chamber cells and flare grade	baseline and at 1, 8, 15, 30 and 60 days postoperatively

Trial Locations

Locations (1)

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto; Centro Avançado de Retina e Catarata; 🇧🇷 Ribeirão Preto, São Paulo, Brazil