The public, particularly the baby boomer and younger generations, has increasingly demanded spectacle independence and near and intermediate vision functionality for computer, smartphone, and other device use to accomplish day-to-day activities important to today's society. New intraocular lens (IOL) technologies have been a significant source of new device submissions to the US Food and Drug Administration (FDA), but the science for testing and evaluating these devices in relation to the patient's needs and functions has not consistently kept up with this accelerated pace of device development. To discuss these challenges, the American Academy of Ophthalmology (Academy) and the FDA held a joint public workshop, “Developing Novel End Points for Premium Intraocular Lenses (IOLs),” on March 24, 2014.
The purpose of this workshop was to discuss current challenges in the assessment of innovative IOL designs, with a focus on end point methodologies used in evaluating IOL safety and effectiveness. The primary goal of the workshop was to improve the regulatory science with respect to the approval of premium IOLs and the efficiency with which they get to market. For our workshop, premium IOLs include toric lenses for clinically significant corneal astigmatism, multifocal and accommodating IOLs to reduce need for reading glasses, and phakic IOLs for ametropia; multifocal IOLs include both refractive and diffractive designs. At the meeting, the FDA announced a new category of IOLs, “extended depth of focus” (EDF), recognizing IOL designs that are intended to enhance intermediate range of vision while maintaining high-quality distance vision; EDF IOLs do not enhance near vision to the same extent as do multifocal IOLs. The workshop brought clinicians, industry, regulators, and other interested parties together to discuss current research and testing methods and stimulated discussion about ideas that could enhance the evaluation process for these new devices. Four important areas were defined: accommodative IOLs, EDF IOLs, patient-reported outcome measures, and adverse event definitions for premium IOLs.
In July 2014, the Academy appointed a task force to follow up with the recommendations made at the workshop. The task force was charged with the development of consensus clinical statements and proposals for nonclinical and clinical research studies, to enhance the efficiency with which safe and effective premium IOLs get to market. The consensus statements are intended to serve as guidelines for the development of clinical protocols for future clinical studies. Dr. Malvina Eydelman, Director of the FDA's Division of Ophthalmic and Ear, Nose and Throat Devices, stated, “This innovative approach to ophthalmic end point development is a game changer. It allowed subject matter experts to address the challenge of premium IOL end points with appropriate input of all interested parties in a very efficient and expeditious manner.”
These consensus statements were later published in Ophthalmology:
- Masket S, Rorer E, Stark W, et al. Special Report: The American of Ophthalmology Task Force Consensus Statement on Adverse Events with Intraocular Lenses. Ophthalmology 2017; 124:142-144.
- MacRae S, Holladay JT, Hilmantel G, et al. Special Report: American Academy of Ophthalmology Task Force Recommendations for Specular Microscopy for Phakic Intraocular Lenses. Ophthalmology. 2017; 124:141-142.
- MacRae S, Holladay JT, Glasser A, et al. Special Report: American Academy of Ophthalmology Task Force Consensus Statement for Extended Depth of Focus Intraocular Lenses. 2017; 124:139-141.
- Holladay JT, Calogero D, Hilmantel G, et al. Special Report: American Academy of Ophthalmology Task Force Summary Statement for Measurement of Tilt, Decentration, and Chord Length. Ophthalmology. 2017; 124:144-146.
- Glasser A, Hilmantel G, Calogero D, et al. Special Report: American Academy of Ophthalmology Task Force Recommendations for Test Methods to Assess Accommodation Produced by Intraocular Lenses. Ophthalmology. 2017; 124:134-139.
Another outcome of the workshop was the general agreement of the need to evaluate patients’ vision quality and its impact on their daily activities through a patient-reported outcome measure (PROM). A PROM (questionnaire) would measure patient acceptance of the devices and the impact of the optical side effects of IOLs, etc., absent the input of clinicians. A unique working collaborative, the American Academy of Ophthalmology (AAO) Advisory Committee, was established for this purpose. It consisted of physician members from the Academy (Samuel Masket, MD, committee chair; Jack Holladay, MD, MSEE; Scott MacRae, MD; and Walter Stark, MD), Rand Corp/UCLA representatives as developers of the written questionnaire, IOL manufacturers (Alcon, Bausch and Lomb, Johnson and Johnson, and Zeiss), and FDA representatives serving in an advisory capacity. The Committee was coordinated by the AAO Hoskins Center, led by Dr. Flora Lum, acting as a neutral convening body. This unique four-armed committee met face to face twice annually to discuss the parameters for study, and organized patient focus groups in several geographic locations in order to help identify concepts most important to patients for the questionnaire. Ultimately, with the help of volunteer surgeons over a wide US geographic distribution and two sites outside the US, approximately 600 patients requiring bilateral cataract surgery were enrolled to test and finalize the questionnaire. The questionnaire included images of various forms of simulated glare, halo, blur, dysphotopsia, etc., that were supplied by Dr. MacRae and his associate Dr. Geunyoung Yoon at the University of Rochester.
All enrolled patients have had the questionnaire administered preoperatively at their ophthalmologist’s office and will have the postoperative questionnaire administered approximately 6 months following second-eye surgery, conforming with previous FDA trials on intraocular lenses. At this time, with great anticipation, we await the results of that testing. Once completed, this questionnaire will be publicly available for all to use.
The Advisory Committee on Patient-Reported Outcome Measures for Premium IOLs includes representatives from the following organizations (in alphabetical order):
American Academy of Ophthalmology
Bausch andBausch and Lomb
Carl Zeiss Meditec
Johnson and Johnson
University of California, Los Angeles
United States Food and Drug Administration (as a Liaison Organization)
The individual members of the Advisory Committee include:
Samuel Masket, MD, Chair, AAO
Malvina Eydelman, MD, FDA Liaison
Ron Hays, PhD, UCLA and RAND
Kendra Hileman, PhD, Alcon
Jack Holladay, MD, AAO
Priya Janakiraman, OD, FAAO, Johnson and Johnson Vision
George Lau, OD, Bausch and Lomb
Scott MacRae, MD, AAO
Tieuvi Nguyen, PhD, FDA Liaison
John O’Riordan, PhD, Alcon
Steven Schallhorn, MD, Carl Zeiss Meditec
Walter Stark, MD, AAO
Nicholas Tarantino, OD, Johnson and Johnson Vision
Michelle Tarver, MD, PhD, FDA Liaison
Beverly Weidmer, RAND
Jon Williams, Bausch and Lomb
Flora Lum, MD
Katherine Salazar-Poss, JD
We are very appreciative of the individual cataract surgeons who selected patients and helped administer the surveys for the field test.
Participating surgeons included:
Dr. Chetan Soni, Citizens Memorial Hospital (CMH) Eye Specialty Center, Missouri
Dr. William Trattler, Center for Eye Excellence in Eyecare, Florida
Dr. George Beiko, Niagara Health Center, Ontario, Canada
Dr. Mitchell Jackson, Jacksoneye, Illinois
Dr. Maria Romero, Precision Eye Care, Maryland
Dr. William Wiley, Cleveland Eye Clinic, Ohio
Dr. Brian Foster, The Eye Associates, Florida
Dr. Cathleen McCabe, The Eye Associates, Florida
Dr. Harvey Reiser, Eye Care Specialists, Pennsylvania
Dr. John Hovanesian, Harvard Eye Associates, California
Dr. Bret Fisher, Eyecarenow, Florida
Dr. Brian Kim, Professional Eye Associates, Georgia
Dr. Arturo Chayet, Codet Vision Institute, Tijuana, Mexico
Dr. James Loden, Loden Vision Centers, Tennessee
Dr. Jonathan Solomon, Bowie Vision Institute, Maryland
Dr. Larry Patterson, Eye Centers of Tennessee
Dr. Kenneth Lu, Doheny Eye Institute, California
Dr. Jeffery Whitman, Key-Whitman Eye Center, Texas
Dr. Mitchell Gossman, Eye Associates of Central Minnesota
Dr. Dan Tran, Coastal Vision Medical Group, California
Dr. Arvind Saini, California Cornea Consultants