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

Sponsor

Grupo de Estudos em Oftalmologia Clínica e Cirúrgica (Other)

Overall Status

Completed

CT.gov ID

NCT01334658

Collaborator

CLIHON (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Procedure: Phacoemulsification cataract surgery Drug: Glucose-bicarbonate-Ringer Lactate (GBRL) Drug: Balanced Salt Solution (BSS®)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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.

Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Balanced Salt Solution (BSS®) Subjects who received Balanced Salt Solution.	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: 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..).
Active Comparator: Glucose-bicarbonate-Ringer Lactate (GBRL) Subjects who received glucose-bicarbonate-Ringer Lactate.	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..).

Arm

Intervention/Treatment

Active Comparator: Balanced Salt Solution (BSS®)

Subjects who received Balanced Salt Solution.

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: Balanced Salt Solution (BSS®)

Active Comparator: Glucose-bicarbonate-Ringer Lactate (GBRL)

Subjects who received glucose-bicarbonate-Ringer Lactate.

Procedure: Phacoemulsification cataract surgery

Drug: Glucose-bicarbonate-Ringer Lactate (GBRL)

Outcome Measures

Primary Outcome Measures

Increase in central corneal thickness (CCT) [Two days after surgery.]
Increase in central corneal thickness (CCT) [Thirty days after surgery.]
Increase in central corneal thickness (CCT) [Ninety days after surgery.]
Decrease in the percentage of endothelial cell density (ECD) [Two days after surgery.]
Decrease in the percentage of endothelial cell density (ECD) [Thirty days after surgery.]
Decrease in the percentage of endothelial cell density (ECD) [Ninety days after surgery.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Grupo de Estudos em Oftalmologia Clínica e Cirúrgica
CLIHON

Investigators

Study Director: Hermelino L Oliveira Neto, CLIHON
Principal Investigator: Israel C Marques Neto, State University of Feira de Santana (UEFS)
Principal Investigator: Brunno B Barros, State University of Feira de Santana (UEFS)