Frequently Asked Questions
What are the IRB's general obligations towards intraocular lens (IOL) clinical investigations? Considering the large number of IOL studies, how does an IRB approach the review of a new IOL style?
An IRB is responsible for the initial and continuing review of all IOL clinical investigations. Each individual IOL style is subject to a separate review by the IRB. This does not, however, preclude the IRB from using prior experience with other IOL investigations in considering the comparative merits of a new lens style. All IOL studies are also subject to FDA approval.
Full IRB review is required for all new IOLs that exhibit major departures from available lenses. Minor changes to existing lenses may be approved through expedited review. FDA designates new IOL styles as either major or minor changes based upon a predetermined classification scheme and advises the sponsor of its determination. The sponsor, through the investigator, should provide the IRB with the investigational plan which indicates the FDA study requirements, as well as the informed consent document and other comparative information on the proposed lens that describes its characteristics. It is the IRB's prerogative to request any relevant information on a new IOL to arrive at a decision or to be more rigorous in its evaluation than FDA considers minimally required.