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

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Phacoemulsification cataract surgery
Glucose-bicarbonate-Ringer Lactate (GBRL)
Balanced Salt Solution (BSS®)
Sponsored by
Grupo de Estudos em Oftalmologia Clínica e Cirúrgica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Corneal endothelium, Cataract surgery, Irrigation solutions intraocular, Phacoemulsification

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Balanced Salt Solution (BSS®)

    Glucose-bicarbonate-Ringer Lactate (GBRL)

    Arm Description

    Subjects who received Balanced Salt Solution.

    Subjects who received glucose-bicarbonate-Ringer Lactate.

    Outcomes

    Primary Outcome Measures

    Increase in central corneal thickness (CCT)
    Increase in central corneal thickness (CCT)
    Increase in central corneal thickness (CCT)
    Decrease in the percentage of endothelial cell density (ECD)
    Decrease in the percentage of endothelial cell density (ECD)
    Decrease in the percentage of endothelial cell density (ECD)

    Secondary Outcome Measures

    Full Information

    First Posted
    April 8, 2011
    Last Updated
    April 12, 2011
    Sponsor
    Grupo de Estudos em Oftalmologia Clínica e Cirúrgica
    Collaborators
    CLIHON
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01334658
    Brief Title
    Study of Corneas Undergoing Balanced Salt Solution(BSS ®) Versus Glucose-bicarbonate-Ringer Lactate in Cataract Surgery
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2010 (undefined)
    Primary Completion Date
    February 2011 (Actual)
    Study Completion Date
    February 2011 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Grupo de Estudos em Oftalmologia Clínica e Cirúrgica
    Collaborators
    CLIHON

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract
    Keywords
    Corneal endothelium, Cataract surgery, Irrigation solutions intraocular, Phacoemulsification

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    64 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Balanced Salt Solution (BSS®)
    Arm Type
    Active Comparator
    Arm Description
    Subjects who received Balanced Salt Solution.
    Arm Title
    Glucose-bicarbonate-Ringer Lactate (GBRL)
    Arm Type
    Active Comparator
    Arm Description
    Subjects who received glucose-bicarbonate-Ringer Lactate.
    Intervention Type
    Procedure
    Intervention Name(s)
    Phacoemulsification cataract surgery
    Intervention Description
    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..).
    Intervention Type
    Drug
    Intervention Name(s)
    Glucose-bicarbonate-Ringer Lactate (GBRL)
    Intervention Description
    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..).
    Intervention Type
    Drug
    Intervention Name(s)
    Balanced Salt Solution (BSS®)
    Intervention Description
    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..).
    Primary Outcome Measure Information:
    Title
    Increase in central corneal thickness (CCT)
    Time Frame
    Two days after surgery.
    Title
    Increase in central corneal thickness (CCT)
    Time Frame
    Thirty days after surgery.
    Title
    Increase in central corneal thickness (CCT)
    Time Frame
    Ninety days after surgery.
    Title
    Decrease in the percentage of endothelial cell density (ECD)
    Time Frame
    Two days after surgery.
    Title
    Decrease in the percentage of endothelial cell density (ECD)
    Time Frame
    Thirty days after surgery.
    Title
    Decrease in the percentage of endothelial cell density (ECD)
    Time Frame
    Ninety days after surgery.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hermelino L Oliveira Neto
    Organizational Affiliation
    CLIHON
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Israel C Marques Neto
    Organizational Affiliation
    State University of Feira de Santana (UEFS)
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Brunno B Barros
    Organizational Affiliation
    State University of Feira de Santana (UEFS)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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