Accomodating iol Chatamature
In addition, they agreed that a collaborative model for PRO development should be pursued. Accommodating IOLs, which vary the focal power of the eye, have the potential to provide an extended range of vision without loss of contrast sensitivity.
Although it is possible to measure accommodation objectively in a clinical study, doing so involves addressing a number of challenges, including the advantages and disadvantages of the instruments used.
Should a single PRO measure that encompasses all types of IOLs be developed?
Finally, can a collaborative mechanism be built that would allow stakeholders to share the development costs of a PRO instrument? Participants agreed that the concepts of subjective quality of vision and visual function are both important—and that they exist independently of a specific IOL technology.
But is the current FDA grid applicable to premium IOLs? Participants felt that the current grid needs little alteration.
The advent of EDOF technology also opens the door to various combinations with other types of lenses, speakers pointed out.
Patients want to see as well as possible, and most want to minimize their dependence on spectacles. What measures might be used to guide IOL regulatory approvals and clinical decision making to best achieve those goals?
The workshop was organized around the following hot topics. Premium IOLs have unique safety risks, “which are an inevitable trade-off for the added benefits that they provide,” said Douglas D. “For example, with toric IOLs, there is the occasional occurrence of postoperative astigmatism due to problems with misalignment and postoperative IOL rotation; in rare instances, this requires surgical reintervention to adjust the axis alignment.” With multifocals, he noted, “Explants may be occasionally required due to complaints about loss of contrast sensitivity and development of visual disturbances.” Because accommodating lenses must move and flex to function, Dr.
Why is it taking so long to get more of these lenses approved? In addition, they discussed a new type of IOL known as the extended depth of focus IOL (see “New Kid on the Block”).
Food and Drug Administration (FDA) explored these questions and more in a first-ever collaborative workshop held this spring.As a result, we evaluate many submissions on a case-by-case basis,” said Malvina B. “Both the FDA and sponsors spend significant resources on repeat submissions, and there’s a delayed or limited benefit to other devices with similar characteristics.” Existing roadblocks. “Because this should improve uncorrected intermediate distance without the optical trade-offs of a diffractive multifocal, this is a technology that would appeal to many cataract patients,” Dr. The goal of the EDOF IOL is to provide improved near and intermediate visual performance without compromising distance vision.