Study of Corneas Undergoing Balanced Salt Solution(BSS ®) Versus Glucose-bicarbonate-Ringer Lactate in Cataract Surgery
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.
1 other identifier
interventional
64
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2010
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 8, 2011
CompletedFirst Posted
Study publicly available on registry
April 13, 2011
CompletedApril 13, 2011
April 1, 2011
6 months
April 8, 2011
April 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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.
Study Arms (2)
Balanced Salt Solution (BSS®)
ACTIVE COMPARATORSubjects who received Balanced Salt Solution.
Glucose-bicarbonate-Ringer Lactate (GBRL)
ACTIVE COMPARATORSubjects who received glucose-bicarbonate-Ringer Lactate.
Interventions
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..).
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..).
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 Criteria
You may qualify if:
- Uncomplicated senile cataract
- Visual acuity (VA) between 20/40 and 20/400
- Healthy corneas
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Grupo de Estudos em Oftalmologia Clínica e Cirúrgicalead
- CLIHONcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 8, 2011
First Posted
April 13, 2011
Study Start
August 1, 2010
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
April 13, 2011
Record last verified: 2011-04