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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Cataract

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Balanced Salt Solution (BSS®)<br>Subjects who received Balanced Salt Solution. | Procedure: Phacoemulsification cataract surgery<br>* 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..).<br>Drug: Balanced Salt Solution (BSS®)<br>* 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..).<br>|
| Active Comparator: Glucose-bicarbonate-Ringer Lactate (GBRL)<br>Subjects who received glucose-bicarbonate-Ringer Lactate. | Procedure: Phacoemulsification cataract surgery<br>* 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..).<br>Drug: Glucose-bicarbonate-Ringer Lactate (GBRL)<br>* 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..).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Corneal endothelium, Cataract surgery, Irrigation solutions intraocular, Phacoemulsification