Study of Corneas Undergoing Balanced Salt Solution(BSS ®) Versus Glucose-bicarbonate-Ringer Lactate in Cataract Surgery

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Procedure: Phacoemulsification cataract surgery; Drug: Balanced Salt Solution (BSS®); Drug: Glucose-bicarbonate-Ringer Lactate (GBRL)

• Registration Number: NCT01334658
• Lead Sponsor: Grupo de Estudos em Oftalmologia Clínica e Cirúrgica

Brief Summary

This is a study aimed at evaluating the effectiveness and impact of two intraocular irrigating solution (BSS ® versus glucose-bicarbonate-Ringer Lactate - GBRL) on the health of the cornea after cataract surgery by phacoemulsification.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2011-04
• Study First Submitted: 2011-04-08
• Study First Submitted QC: 2011-04-12
• Last Update Submitted: 2011-04-12
• Study First Posted: 2011-04-13
• Last Update Posted: 2011-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Uncomplicated senile cataract
• Visual acuity (VA) between 20/40 and 20/400
• Healthy corneas

Exclusion Criteria

• Mental incapacity
• Patients with coexisting diseases of the cornea
• Presence of corneal opacity
• Uncontrolled glaucoma
• Uncontrolled diabetes mellitus
• Uveitis
• Cells or flare in the anterior chamber
• Prior intraocular surgery
• Patients using topical steroids or systemic
• Traumatic cataract, hereditary or toxic

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balanced Salt Solution (BSS®)	Phacoemulsification cataract surgery	Subjects who received Balanced Salt Solution.
Balanced Salt Solution (BSS®)	Balanced Salt Solution (BSS®)	Subjects who received Balanced Salt Solution.
Glucose-bicarbonate-Ringer Lactate (GBRL)	Phacoemulsification cataract surgery	Subjects who received glucose-bicarbonate-Ringer Lactate.
Glucose-bicarbonate-Ringer Lactate (GBRL)	Glucose-bicarbonate-Ringer Lactate (GBRL)	Subjects who received glucose-bicarbonate-Ringer Lactate.

Primary Outcome Measures

Name	Time	Method
Increase in central corneal thickness (CCT)	Ninety days after surgery.
Decrease in the percentage of endothelial cell density (ECD)	Ninety days after surgery.