Trial | NCT01334658  Report issue

Title

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.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    64
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.
Study Started
Aug 31
2010
Primary Completion
Feb 28
2011
Study Completion
Feb 28
2011
Last Update
Apr 13
2011
Estimate

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..).

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..).

Balanced Salt Solution (BSS®) Active Comparator

Subjects who received Balanced Salt Solution.

Glucose-bicarbonate-Ringer Lactate (GBRL) Active Comparator

Subjects who received glucose-bicarbonate-Ringer Lactate.

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
No Results Posted