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

Grupo de Estudos em Oftalmologia Clínica e Cirúrgica

Status: Completed

Conditions: Cataract

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01334658

100

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups

Balanced Salt Solution (BSS®)

Active Comparator group

Description:

Subjects who received Balanced Salt Solution.

Treatment:

Drug: Balanced Salt Solution (BSS®)

Procedure: Phacoemulsification cataract surgery

Glucose-bicarbonate-Ringer Lactate (GBRL)

Active Comparator group

Description:

Subjects who received glucose-bicarbonate-Ringer Lactate.

Treatment:

Drug: Glucose-bicarbonate-Ringer Lactate (GBRL)

Procedure: Phacoemulsification cataract surgery