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

Cataract Clinical Trial

Official title:

Study of Endothelial Cell Density of Corneas Undergoing Phacoemulsification Surgery Using Balanced Salt Solution (BSS ®) Versus Glucose-bicarbonate-Ringer Lactate as Irrigating Solution: a Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01334658
• Other study ID #: 100
• Status: Completed
• Phase: N/A
• First received: April 8, 2011
• Last updated: April 12, 2011
• Start date: August 2010
• Est. completion date: February 2011

Study information

• Verified date: April 2011
• Source: Grupo de Estudos em Oftalmologia Clínica e Cirúrgica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• Phacoemulsification cataract surgery
A group received BSS ® (ALCON LABORATORIES, INC.) and another group received glucose-bicarbonate-Ringer Lactate (GBRL) [500 cc. Ringer Lactate (GLICOLABOR, Pharmaceutical LTD.) enriched with 1.5 ml of glucose in water (25%) and 08 ml of sodium bicarbonate (8.4%)] as a solution for irrigation during surgery. All surgeries were performed by single surgeon (HON), using the standard surgical technique quick-chop. Immediately before surgery, solutions for irrigation [BSS ® (ALCON LABORATORIES, INC..) and glucose-bicarbonate-Ringer Lactate (GBRL)] were brought to the operating table in a temperature of 22 degrees Celsius. The microcoaxial Phacoemulsification was performed under a phaco Legacy Series 20000 (ALCON LABORATORIES, INC..).

Drug:
• Glucose-bicarbonate-Ringer Lactate (GBRL)
A group received BSS ® (ALCON LABORATORIES, INC.) and another group received glucose-bicarbonate-Ringer Lactate (GBRL) [500 cc. Ringer Lactate (GLICOLABOR, Pharmaceutical LTD.) enriched with 1.5 ml of glucose in water (25%) and 08 ml of sodium bicarbonate (8.4%)] as a solution for irrigation during surgery. All surgeries were performed by single surgeon (HON), using the standard surgical technique quick-chop. Immediately before surgery, solutions for irrigation [BSS ® (ALCON LABORATORIES, INC..) and glucose-bicarbonate-Ringer Lactate (GBRL)] were brought to the operating table in a temperature of 22 degrees Celsius. The microcoaxial Phacoemulsification was performed under a phaco Legacy Series 20000 (ALCON LABORATORIES, INC..).
• Balanced Salt Solution (BSS®)
A group received BSS ® (ALCON LABORATORIES, INC.) and another group received glucose-bicarbonate-Ringer Lactate (GBRL) [500 cc. Ringer Lactate (GLICOLABOR, Pharmaceutical LTD.) enriched with 1.5 ml of glucose in water (25%) and 08 ml of sodium bicarbonate (8.4%)] as a solution for irrigation during surgery. All surgeries were performed by single surgeon (HON), using the standard surgical technique quick-chop. Immediately before surgery, solutions for irrigation [BSS ® (ALCON LABORATORIES, INC..) and glucose-bicarbonate-Ringer Lactate (GBRL)] were brought to the operating table in a temperature of 22 degrees Celsius. The microcoaxial Phacoemulsification was performed under a phaco Legacy Series 20000 (ALCON LABORATORIES, INC..).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Grupo de Estudos em Oftalmologia Clínica e Cirúrgica	CLIHON

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in central corneal thickness (CCT)		Two days after surgery.	No
Primary	Increase in central corneal thickness (CCT)		Thirty days after surgery.	No
Primary	Increase in central corneal thickness (CCT)		Ninety days after surgery.	No
Primary	Decrease in the percentage of endothelial cell density (ECD)		Two days after surgery.	No
Primary	Decrease in the percentage of endothelial cell density (ECD)		Thirty days after surgery.	No
Primary	Decrease in the percentage of endothelial cell density (ECD)		Ninety days after surgery.	No