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

This study has been completed.
Sponsor:
Collaborator:
CLIHON
Information provided by:
Grupo de Estudos em Oftalmologia Clínica e Cirúrgica
ClinicalTrials.gov Identifier:
NCT01334658
First received: April 8, 2011
Last updated: April 12, 2011
Last verified: April 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Grupo de Estudos em Oftalmologia Clínica e Cirúrgica:

Primary Outcome Measures:
  • Increase in central corneal thickness (CCT) [ Time Frame: Two days after surgery. ] [ Designated as safety issue: No ]
  • Increase in central corneal thickness (CCT) [ Time Frame: Thirty days after surgery. ] [ Designated as safety issue: No ]
  • Increase in central corneal thickness (CCT) [ Time Frame: Ninety days after surgery. ] [ Designated as safety issue: No ]
  • Decrease in the percentage of endothelial cell density (ECD) [ Time Frame: Two days after surgery. ] [ Designated as safety issue: No ]
  • Decrease in the percentage of endothelial cell density (ECD) [ Time Frame: Thirty days after surgery. ] [ Designated as safety issue: No ]
  • Decrease in the percentage of endothelial cell density (ECD) [ Time Frame: Ninety days after surgery. ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: August 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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..).


  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01334658

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)
  More Information

No publications provided

Responsible Party: Hermelino Lopes de Oliveira Neto, GEOCC
ClinicalTrials.gov Identifier: NCT01334658     History of Changes
Other Study ID Numbers: 100
Study First Received: April 8, 2011
Last Updated: April 12, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Grupo de Estudos em Oftalmologia Clínica e Cirúrgica:
Corneal endothelium
Cataract surgery
Irrigation solutions intraocular
Phacoemulsification

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 14, 2014