Assessment of Clinical Trials for Devices Intended to Control Myopia Progression in Children.

The increased prevalence of myopia in the United States and other regions of the world, and the sight-threatening problems associated with higher levels of myopia have led to great interest in research designed to reduce these rates. As most of the progression of myopia occurs in childhood, these investigations have been directed toward slowing the progression of myopia in children. Treatments described to potentially slow the progression of myopia have included pharmacological interventions, multifocal spectacles, and multifocal correction created by contact lenses. Although some contact lens clinical trials have demonstrated promising results in slowing the progression of myopia, many of these studies have significant limitations, including only short follow-up times, limited randomization, and incomplete masking. Such limitations have underscored the need to develop a more robust clinical study design, so that future studies can demonstrate whether contact lenses, as well as other medical devices, can be used in a safe and effective manner to control myopia progression. We review previous key studies and discuss study design and regulatory issues relevant to future clinical trials.

Food and Drug Administration, American Academy of Ophthalmology, American Academy of Optometry, American Association for Pediatric Ophthalmology and Strabismus, American Optometric Association, American Society of Cataract and Refractive Surgery, and Contact Lens Association of Ophthalmologists Co-Sponsored Workshop: Controlling the Progression of Myopia: Contact Lenses and Future Medical Devices.

The prevalence of myopia is high and increasing. Approximately 5 billion people around the world are expected to be myopic by the year 2050. Methods to slow the progression of myopia and therefore potentially decrease the associated sight-threatening complications have been the subject of a number of investigations. A workshop, sponsored by the United States Food and Drug Administration (FDA) Center for Devices and Radiological Health, American Academy of Ophthalmology, American Academy of Optometry, American Association for Pediatric Ophthalmology and Strabismus, American Optometric Association, American Society of Cataract and Refractive Surgery, and Contact Lens Association of Ophthalmologists, Inc, convened myopia experts from around the world to discuss principles to consider in the design of clinical trials investigating the effectiveness and safety of myopia control devices. Experts discussed parameters such as study endpoints, duration, enrollment criteria, patient-reported outcomes, recruitment, and retention. The discussions among the experts, FDA, and audience members should help to facilitate the development and evaluation of reasonably safe and effective myopia control devices.

Contact lens-associated corneal infiltrates.

PURPOSE This review article examines recent studies pertaining to contact lens-associated corneal infiltrates (CLACI) that occur in the absence of culture-proven microbial infection. METHODS The literature was reviewed in regard to the clinical appearance, incidence and risk, etiology, pathophysiology, differential diagnosis, and management of CLACI. Recent insights are presented in the context of future directions for prevention of CLACI. RESULTS Contact lens-associated corneal infiltrates may manifest in various forms that require careful observational skills to ensure proper diagnosis. Although the reported incidence of CLACI varies widely, even a low percentage of contact lens wearers would constitute a substantial number of affected individuals. Any one or a combination of multiple mechanical, hypoxic, or toxic stimuli associated with contact lens use can induce proinflammatory responses that lead to infiltration of inflammatory cells into the cornea. A number of candidate cytokines, chemokines, adhesion molecules, and so forth have been identified. In addition to differentiation from microbial keratitis, CLACI also should be differentiated from ocular disorders not associated with contact lenses but involving corneal infiltrates and from contact lens-associated disorders that may resemble infiltrates. Management of CLACI can range from simple monitoring of the patient to the use of pharmacologic intervention. CONCLUSIONS The small percentage of affected lens wearers translates into a notable number of individuals who, although not experiencing a vision-threatening event, are inconvenienced by the development of infiltrates. Design of preventive measures for CLACI should focus on the elimination of various mechanical, hypoxic, and toxic stimuli that can induce infiltrates and on the approaches for molecular intervention of the inflammatory cascade initiated by the stimuli.