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Speakers discussed ANSI/ISO draft standards for objective assessments (such as dynamic aberrometry and dynamic autorefraction) of accommodating IOLs and questioned whether the field should be developing standard operating procedures for optical and biometric methods.(For instance, ANSI and ISO require 1 D of objectively measured accommodation for a device to be called an accommodative IOL.) Breakout consensus.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.Obstacles to approval include “a lack of consensus in some preclinical issues, on best clinical trial design, and [on] appropriate safety and effectiveness endpoints,” Dr. Additionally, there is a need for new categories of IOLs, “based on new optical properties and/or benefits to patients,” she said. “We can continue to evaluate each submission one at a time and take a long and winding road, or we can do what we’re trying to attempt [in this workshop]—develop the novel endpoints for premium IOLs,” Dr. “This could be accomplished, for example, by positive spherical aberrations of a monofocal optic,” Dr. Theoretically, patients with the EDOF IOL should be less troubled by glare and halos and experience less loss of contrast at distance, compared with a diffractive multifocal lens.During the workshop, participants discussed a number of issues to consider beyond the traditional statistical measures of precision, reproducibility, validity, and responsiveness.For instance, how best can the words patients use to describe visual phenomena (such as starbursts, comets, and halos) be parsed?The medical term for this condition is called presbyopia.
Patients can rarely experience glare and halos from a smaller optic zone and irregular astigmatism related to optic flexure.” As for phakic IOLs, he said, “There have been reports of increased risk of corneal decompensation, uveitis, and glaucoma.” When FDA reviewers evaluate the safety and performance of a new IOL, they compare the number of patients with a particular AE to an allowed rate of cumulative and persistent AEs on what’s known as the FDA “grid” (its formal name is “Safety and Performance Endpoints”).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.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.
For instance, EDOF optics could be added to toric optics to provide extended depth of focus for toric IOLs—or added to accommodative optics to boost near performance.