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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Eye Diseases
Lens Diseases
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014