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| Name | Class |
|---|---|
| CLIHON | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balanced Salt Solution (BSS®) | Active Comparator | Subjects who received Balanced Salt Solution. |
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| Glucose-bicarbonate-Ringer Lactate (GBRL) | Active Comparator | Subjects who received glucose-bicarbonate-Ringer Lactate. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phacoemulsification cataract surgery | Procedure | 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..). |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hermelino L Oliveira Neto | CLIHON | Study Director |
| Israel C Marques Neto | State University of Feira de Santana (UEFS) | Principal Investigator |
| Brunno B Barros | State University of Feira de Santana (UEFS) | Principal Investigator |
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| Glucose-bicarbonate-Ringer Lactate (GBRL) | Drug | 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®) | Drug | 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..). |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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