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AAO publishes consensus statement on IOL adverse events
The FDA grid on safety and performance endpoints has not been updated to include premium IOLs.
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Definitions for a number of postoperative adverse events associated with IOLs and definitions of indications for IOL exchange, removal or reposition have been published in Ophthalmology.
The special report from an American Academy of Ophthalmology Task Force began in March 2014 at a public workshop in the Washington, D.C., area that was organized by the FDA to develop novel endpoints for premium IOLs. In attendance were representatives from industry, the FDA and the AAO.
“It has not been since 1983, with a small update in 1998, that there has been a new FDA grid, to evaluate the performance and safety endpoints of IOLs,” primary author Samuel Masket, MD, a clinical professor of ophthalmology at Jules Stein Eye Institute in Los Angeles, said. Masket was invited to participate in the workshop because of his interest in undesired light imagery associated with IOLs.
“With the evolution of premium IOLs, which are defined as lenses that are intended to reduce spectacle dependence, there have been no guidelines for investigation of performance of these lenses, which include multifocal IOLs, toric IOLs, accommodating IOLs, phakic IOLs and extended depth of focus IOLs, a new category of lenses,” Masket told Ocular Surgery News.
In response, the AAO task force revisited the historical FDA grid to determine the issues that were pertinent going forward.
“We also looked at new categories of investigation that would be relevant to premium IOLs,” Masket said. “In current development is a patient-reported outcome instrument.” The AAO, FDA, Rand Corporation and representatives from industry are collaborating in the development process.
List of adverse events
The report lists, defines and references to the existing literature a total of 11 potential IOL adverse events: chronic anterior uveitis, clinically significant cystoid macular edema, corneal edema, endophthalmitis, mechanical pupillary block, increased IOP, rhegmatogenous retinal detachment, toxic anterior segment syndrome and three secondary IOL interventions (exchange, removal and reposition).
“What differentiates this process from the previous process is that we are going to be looking at patient-reported outcomes, including optical malfunctions of IOLs,” Masket said.
The report also has definitions for 13 indications for IOL exchange, removal or reposition: capsular block syndrome, cataract, chronic anterior uveitis, endothelial cell loss, incorrect IOL power, iris pigment epithelium loss, lens optic abnormality, malpositioned IOL (early and late), damaged IOL, pupil ovalization, pain, peripheral anterior synechiae and patient-reported undesirable optical phenomena.
“One of the other modules of the report will be the expected performance patterns for accommodating lenses, extended depth of focus lenses and toric lenses, among others,” Masket said. “Each of those categories will have performance standards which can be viewed by interested parties.”
Oval pupil management
An appendix to the report covers oval pupil management background and standard operating procedure. “The literature was very sparse; in fact, there is only one reference for ovalization of the pupil,” Masket said. “Because we did not have a compendium of literature, we made a new definition for that process.”
A second appendix addresses IOL tilt. “While there is literature on tilt, there has not been a well-received clinical method for measuring it,” Masket said.
Masket believes there has been concern and confusion among clinicians, as well as the manufacturing sector, as to how the AAO would be evaluating performance and safety of premium IOLs moving forward, “given the rapid expansion of technology. The process is designed to hopefully create some guidance for that process.”
However, the process, which is a catalyst for future reporting of patient observations about the performance of premium IOLs, “is not specifically designed for the patient,” Masket said. “It is designed for the clinician and for the manufacturing sector to evaluate performance and safety of premium lenses.”
Moreover, although the purpose of developing safety endpoints is specifically for premium IOLs, “my sense is that it will be extended to all new IOLs in time,” Masket said. – by Bob Kronemyer
- Reference:
- Masket S, et al. Ophthalmology. 2016;doi:10.1016/j.ophtha.2016.09.031.
- For more information:
- Samuel Masket, MD, can be reached at Advanced Vision Care, 2080 Century Park East, Suite 911, Los Angeles, CA 90067; email: avcmasket@aol.com.
Disclosure: Masket reports no relevant financial disclosures.