SBIR-STTR Award

Recent studies suggested that blue light may present a hazard to the retina of the ageing population. Yellow IOLs, which absorb blue-light, mimic the transmission characteristics of an aged human crystalline lens, protect lipofucsin-containing retinal pigment epithelial cells from being damaged by blue-light. There is indirect evidence that the blue light absorption IOL may reduce the risk for macular degeneration or its progression. On the other hand, the blue light blocking yellow lenses have been reportedly compromised the color perception, especially under scotopic (dim light) conditions, such as night driving. SmartYellowTM Lens, a photochromic hydrophobic acrylic IOL is designed to overcome the dilemma of a yellow IOL. Under scotopic conditions wherein the UV and blue light is very weak or non-exist, SmartYellowTM lens remains clear like a normal UV-blocking IOL while under photopic conditions, such as outdoor in a sunny day wherein both UV and the blue light is abundant, it turns into yellow color; It blocks both UV light and blue light, thus providing additional protection for retina. PI's group has conducted preliminary experiments indicating that incorporating photochromic dyes into hydrophobic IOLs is feasible and resulted IOLs are biocompatible in a 6 month rabbit study (by Dr. Nick Mamalis at University of Utah). In addition, PI has also completed an accelerated UV ageing study indicating that the photochromic Matrix IOL has a lifetime 23 years, exceeding ISO (11979-5) requirement of 20 years. This grant application, when approved will pave the way for human clinical trials in the US in later 2008. Annual cataract procedures in the US alone exceed 2.5 million. SmartYellowTM lens not only blocks UV light, it also blocks harmful blue light when exposed to UV. Thus, it provides cataract patients with additional protection for retina by reducing the risk of macular degeneration or its progression

There is mounting evidence that blue light, like UV light, presents a hazard to the eye of the aging population.1-9 Yellow intraocular lenses (IOLs), which absorb blue light, mimic the transmission characteristics of an aged human crystalline lens and aim to protect lipofucsin-containing retinal pigment epithelial cells from being damaged by blue light. Recent studies indicate that a blue-light-absorbing IOL may reduce the risk for macular degeneration or its progression.2,3,6-11 Most importantly, a recent European Eye Study(October, 2008) involving 4753 participants aged 65 or older found a significant association between blue light exposure and neovascular or early AMD in individuals in the quartile of lowest antioxidants levels in their blood stream; the study concluded that the general population should use ocular protection and follow dietary recommendations for key antioxidant nutrients.12 Accordingly, yellow IOLs are increasingly used by surgeons; approximately half of the IOLs used in the US are blue-light-blocking. However, two recent intra-individual comparison studies13-14 in humans found that yellow IOLs have lower visual acuity and poor color vision perception compared with the clear lens (non-yellow) counterpart under low light conditions. Recent studies also suggested that patients with yellow IOLs may suffer from disrupted circadian rhythm.15 AuriumTM, a photochromic hydrophobic acrylic IOL, is designed to provide all benefits of a yellow IOL without any of its compromises. The design was based on the fact that blue-light intensity in outdoor sunlight is about 10 times stronger than indoor light wherein blue-light is weak and often necessary for good vision (Fig. 1).16 AuriumTM remains clear indoors while outdoors, where both UV and blue light are intense and harmful, it turns yellow and blocks both UV and blue light. Figure 1. Blue Light Intensity: Sunlight scale is on right; indoor light scale is on left All SBIR Phase I experiments have been successfully completed: AuriumTM is biocompatible and photochemically stable; AuriumTM meets all ISO requirements for IOLs and a CE Mark has been obtained. Now we apply for a SBIR Phase II grant to obtain an Investigational Device Exemption (IDE) for the US market.

Public Health Relevance:
Approximately half of 3 million cataract procedures in the US use yellow intraocular lenses (IOLs) which reduce the risk of or slow the progression of macular degeneration, 1-7 a major cause for blindness among population over 50.17, 18 Yellow IOLs achieve this by blocking hazardous blue light in addition to UV but they also lower night vision and color perception for patients.12,13 AuriumTM, a photochromic IOL preserves all the benefits of a yellow IOL without any of its compromises and may become a standard for future IOLs.

Public Health Relevance Statement:
Approximately half of 3 million cataract procedures in the US use yellow intraocular lenses (IOLs) which reduce the risk of or slow the progression of macular degeneration, 1-7 a major cause for blindness among population over 50.17, 18 Yellow IOLs achieve this by blocking hazardous blue light in addition to UV but they also lower night vision and color perception for patients.12,13 AuriumTM, a photochromic IOL preserves all the benefits of a yellow IOL without any of its compromises and may become a standard for future IOLs.

Project Terms:
Accidents; Actinic Rays; Age; Aging; Antioxidants; Area; Arts; Automobile Driving; Biocompatible; Blindness; Blood; Cataract; Characteristics; Circadian Rhythms; Color; Color Perception; Color Visions; Coloring Agents; Crystalline Lens; Devices; Diurnal Rhythm; Dose; Drivings, Automobile; Dyes; Environment; Equipment; European; Eye; Eyeball; Figs; Figs - dietary; Frequencies (time pattern); Frequency; Fungi, Filamentous; Future; General Population; General Public; Glare; Grant; Human; Human, General; Individual; Intraocular lens implant device; Left; Len, Crystalline; Len, Eye; Lens; Lens of Eye; Lens, Crystalline; Lens, Eye; Lenses; Lenses, Intraocular; Light; Macular degeneration; Macular degenerative disease; Man (Taxonomy); Man, Modern; Marketing; Measures; Mechanics; Molds; Nutrient; Nyctohemeral Rhythm; Ocular Lens; Optics; Outer pigmented layer of retina; Participant; Patients; Perception; Phase; Photoradiation; Pigment cell layer of retina; Pigmented layer of retina; Population; Procedures; Prolate; Recommendation; Reticuloendothelial System, Blood; Retinal Pigment Epithelium; Retinal pigment epithelial cells; Right-On; Risk; SBIR; SBIRS (R43/44); Safety; Senescence; Sight; Small Business Innovation Research; Small Business Innovation Research Grant; Stream; Structure of retinal pigment epithelium; Sun/Ultra-Violet Rays; Sunlight; Surface; Surgeon; Testing; Time; Transmission; Twenty-Four Hour Rhythm; UV radiation; Ultraviolet Rays; Validation; Vision; Visions, Color; Visual Acuity; aged; anti-oxidant; base; biocompatibility; biomaterial compatibility; cataractogenesis; cataractous lenses; chromophore; circadian; circadian process; daily biorhythm; design; designing; diurnal variation; driving; experiment; experimental research; experimental study; hazard; improved; lens; light intensity; manufacturing process; meetings; neovascular; new technology; pre-clinical; preclinical; public health relevance; research study; response; senescent; tool; transmission process; ultraviolet light; ultraviolet radiation