VisionBlue®
GoodRxTrypan Blue 0.06% · intraocular solution
Diagnostic Dye
IndicationVisionBlue® 0.06% is a diagnostic dye indicated for use as an aid in ophthalmic surgery by staining the anterior capsule of the lens.
Contraindications
Planned insertion of a non-hydrated (dry-state) hydrophilic acrylic intraocular lens, because the lens may absorb the dye and become stained
Available Forms0.06% solution: 0.5 mL in a single-patient-use 2.25 mL syringe; one syringe or a carton of ten syringes
Mechanism of ActionVisionBlue® 0.06% selectively stains connective tissue structures in the human eye such as the anterior lens capsule of the human crystalline lens. VisionBlue® 0.06% is intended to be applied directly on the anterior lens capsule, staining any portion of the capsule which comes in contact with the dye. Excess dye is washed out of the anterior chamber. The dye does not penetrate the capsule, permitting visualization of the anterior capsule in contrast to the non-stained lens cortex and inner lens material.
DosageCataract surgery. VisionBlue® 0.06% is packaged in a single-patient-use syringe filled to a volume of 0.5 mL syringe to which a blunt cannula has to be attached. After opening the eye, an air bubble is injected into the anterior chamber of the eye in order to minimize dilution of VisionBlue® 0.06% by the aqueous. VisionBlue® 0.06% is carefully applied onto the anterior lens capsule using a blunt cannula. Sufficient staining is achieved as soon as the dye has contacted the capsule. The anterior chamber is then irrigated with balanced salt solution to remove all excess dye. An anterior capsulotomy can then be performed.
Warnings & Precautions
Excessive staining: It is recommended that after injection all excess VisionBlue® 0.06% is immediately removed from the eye by thorough irrigation of the anterior chamber.
Common Side Effects
Adverse reactions reported following use of VisionBlue® 0.06% include discoloration of high water content hydrogen intraocular lenses and inadvertent staining of the posterior lens capsule and vitreous face. Staining of the posterior lens capsule or staining of the vitreous face is generally self limited, lasting up to one week.
Pregnancy & LactationPregnancy: There are no available data on the use of VisionBlue® 0.06% in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Trypan blue has been shown to be teratogenic in various animal models at doses 800-fold and greater than the maximum recommended human dose, based on body surface area (BSA). Due to the negligible human systemic exposure when used as recommended, maternal use is not expected to result in fetal exposure to the drug and risk of teratogenic effects.
Lactation: The presence of trypan blue in human milk following intraocular administration of trypan blue has not been evaluated. There are no data available regarding the effects of trypan blue on milk production. Breastfeeding is not expected to result in exposure of the child to trypan blue due to the negligible systemic exposure of trypan blue in humans following injection and subsequent removal of the drug at the completion of surgical procedures.
Pediatric UseThe safety and effectiveness of trypan blue have been established in pediatric patients. Use of trypan blue is supported by evidence from an adequate and well-controlled study in pediatric patients.