Objective: This document evaluates currently available data in the published literature to answer the question of whether the use of dye such as indocyanine green or trypan blue to stain the lens capsule to improve visualization is safe and effective as an adjunct to cataract surgery. Methods: Literature searches conducted in March 2003 and May 2004 retrieved 139 citations. The panel members reviewed the abstracts and selected 47 of possible clinical relevance for review. An additional 14 articles were identified for evaluation. Of the 61 articles reviewed, the panel members selected 36 for the panel methodologist to review and rate according to the strength of the evidence. A level I rating was assigned to properly conducted, well-designed, randomized clinical trials; a level II rating was assigned to well-designed cohort and case-control studies; and a level III rating was assigned to case series and case reports. Results: There is level III evidence that indocyanine green, trypan blue, and fluorescein are each effective in staining the lens capsule and that indocyanine green and trypan blue provide better ease of use and visualization of the capsule than fluoroscein. There is level II evidence that staining the capsule is helpful in completing capsulorrhexis and that it is helpful for pediatric patients under age 5 years and in cases of white cataract. The overall surgical advantage of a completed continuous curvilinear capsulorrhexis using dye has not been demonstrated, but this may be related to the outcome measures chosen rather than a failure to confer advantage. There are substantial data indicating that trypan blue 0.1% is not toxic to the cornea. There are limited data suggesting that indocyanine green 0.125% to 0.5% is not toxic to anterior segment structures. Conclusions: There are data confirming that dye is safe and effective as an adjunct for capsule visualization in cataract surgery. It is reasonable to use dye when inadequate capsule visualization may compromise the outcome in cataract surgery. More studies are needed to confirm a lack of toxicity of indocyanine green and trypan blue, particularly in the event of posterior segment or longer duration exposure.
ASJC Scopus subject areas