SBIR-STTR Award

A Database of IOL Position and Behavior
Award last edited on: 6/28/11

Sponsored Program
SBIR
Awarding Agency
NIH : NEI
Total Award Amount
$938,225
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Susan A Strenk

Company Information

MRI Research Inc (AKA: Diagnostic Instruments Inc)

16020 Glenridge Avenue
Cleveland, OH 44130
   (440) 234-5112
   mriresearch@wowway.com
   N/A
Location: Single
Congr. District: 16
County: 

Phase I

Contract Number: 1R43EY015655-01
Start Date: 00/00/00    Completed: 00/00/00
Phase I year
2004
Phase I Amount
$100,000
The high-resolution MRI techniques developed by the Principal Investigator, offer unsurpassed image contrast, are non-invasive, permit the acquisition of images in any desired plane without obscuring vision, and provide undistorted in vivo visualization of the IOL/crystalline lens position in relation to the intraocular structures during accommodation and with accommodation at rest; this information cannot be obtained by any other method. The ultimate goal of this study is to produce a biometric database combining measurements obtained from MRI images and Scheimpflug images acquired from IOL patients and provide a detailed description of IOL placement and accommodative behavior in relation to the intraocular structures - including both successful and unsuccessful surgical outcomes from a variety of IOL types. The Phase I specific aims include: 1) collecting accommodative MRI data from the intact eye of cataract patients with monocular IOL implantation and measuring accommodative and age-related changes in the anterior segment anatomy; 2) collecting MRI corresponding data, from contralateral eye and measuring accommodative and age-related changes in both anterior segment anatomy and IOL position, tilt (in multiple planes) and decentration; and 3) combining the MR measurements obtained from the intact eye with our existing MR measurements and comparing these data with existing Scheimpflug data.

Thesaurus Terms:
biomaterial evaluation, biomimetics, cataract, eye prosthesis, information system, neuroanatomy, neuroimaging, postoperative complication aging, eye accommodation, eye disorder diagnosis, noninvasive diagnosis bioengineering /biomedical engineering, bioimaging /biomedical imaging, clinical research, human data, human subject, magnetic resonance imaging, medical implant science, patient oriented research, vision test

Phase II

Contract Number: 2R44EY015655-02
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
2009
(last award dollars: 2010)
Phase II Amount
$838,225

Cataract surgery is a common procedure that results in removal of the human lens and its replacement with an intraocular lens (IOL). It is a safe procedure, but complications do occur. Many new IOLs are being designed to further improve vision after cataract surgery; however, concerns exist regarding both the safety and effectiveness of these new designs. Magnetic resonance imaging has the unique ability to fully show the IOL position in the intact eye thus providing information to permit better and safer IOLs and other ocular implants and procedures to be designed. Presbyopia is the loss of accommodation with age and industry efforts to provide surgical correction for presbyopia are vigorously underway as the potential market for such a product is substantial. Strategies include lens refilling, scleral treatments, and, most notably, the development of accommodating intraocular lenses (A-IOLs). However, despite this renewed interest in IOLs for the correction of presbyopia (as well as myopia, hyperopia, and astigmatism), many questions remain regarding the: optic and haptic sizing and post-operative positional stability, development of Soemmering's ring and posterior capsule opacification (PCO), power calculations, and adverse effects of these and even established IOL designs. The high-resolution MRI techniques developed by the Principal Investigator are not hampered by the iris and are thus able to provide non-invasive visualization of the entire IOL (optic and haptics) and fully characterize its geometric relationship to surrounding intraocular structures both during accommodation and with accommodation at rest; this information cannot be obtained from the intact eye by any other method. The ultimate goal of this project is to produce a biometric database of the unique information obtained from MRI images of the pseudophakic eye in order to fully characterize IOL placement in the anterior segment. Moreover, posterior capsule opacification is a common complication of cataract surgery that decreases visual acuity, has been correlated with IOL tilt and decentration, and is of particular concern with new IOL designs. Soemmering's ring, develops after virtually every IOL implantation, is a direct precursor to PCO, is associated with other complications including pupillary block glaucoma, and our MRI data suggest that it is also closely associated with IOL malposition. We plan to non-invasively grade Soemmering's ring in vivo with MRI and correlate Soemmering's ring development with anterior segment biometry and IOL type, position, tilt, decentration, and accommodative behavior. Successful completion of this project will facilitate the construction of models that allow better traditional, phakic, and accommodating IOL designs as well as other methods of presbyopia correction to be simulated and developed. Moreover, it will facilitate the construction of refined algorithms for preoperative IOL power calculations and improve our understanding of post-operative complications of IOL surgery.

Public Health Relevance:
Cataract surgery is the most common surgery in the world and its frequency will increase as the population ages. In this surgery, the human lens is removed and replaced with an intraocular lens (IOL). It is a safe procedure, but complications do occur and vision after surgery is not always optimal. Many new IOLs are being designed to further improve vision after cataract surgery; however, concerns exist regarding both the safety and effectiveness of these new designs. Magnetic resonance imaging has the unique ability to fully show the IOL location inside eye and how this changes depending upon whether one is looking far or near. Thus measurements will be made to better understand IOL location inside the eye and the complications that can occur with cataract surgery. This information will permit better and safer IOLs and other eye implants be designed to improve vision as well as treat eye diseases.

Public Health Relevance Statement:
Cataract surgery is the most common surgery in the world and its frequency will increase as the population ages. In this surgery, the human lens is removed and replaced with an intraocular lens (IOL). It is a safe procedure, but complications do occur and vision after surgery is not always optimal. Many new IOLs are being designed to further improve vision after cataract surgery; however, concerns exist regarding both the safety and effectiveness of these new designs. Magnetic resonance imaging has the unique ability to fully show the IOL location inside eye and how this changes depending upon whether one is looking far or near. Thus measurements will be made to better understand IOL location inside the eye and the complications that can occur with cataract surgery. This information will permit better and safer IOLs and other eye implants be designed to improve vision as well as treat eye diseases.

NIH Spending Category:
Aging; Bioengineering; Clinical Research; Eye Disease and Disorders of Vision; Neurosciences

Project Terms:
Abscission; Academia; Adverse effects; Affect; Age; Aging; Algorithms; Anatomic; Anatomical Sciences; Anatomy; Anterior; Anterior Chamber; Anterior Chamber of the Eye; Anterior chamber of eye structure; Area; Astigmatism; Behavior; Biometrics; Biometry; Biometry and Biostatistics; Biostatistics; Blood-Aqueous Barrier; Body Tissues; CAPS; Cadaver; Capsules; Cataract; Cataract Extraction; Chronic; Ciliary Muscle; Ciliary muscle structure; Climate; Complement; Complement Proteins; Complication; Computer Programs; Computer software; Contrast Sensitivity; Corneal Endothelium; Crystalline Lens; Data; Data Banks; Data Bases; Data Set; Databank, Electronic; Databanks; Database, Electronic; Databases; Dataset; Development; Devices; Dislocations; Educational process of instructing; Effectiveness; Effects, Longterm; Endothelial Cells; Excision; Extirpation; Eye; Eye diseases; Eyeball; FDA approved; Farsightedness; Frequencies (time pattern); Frequency; Generalized Growth; Glare; Glaucoma; Goals; Growth; Healed; Housing; Human; Human, General; Hypermetropia; Hyperopia; Hyphema; Image; Imagery; Implant; Implantation procedure; In Vitro; Industry; Intraocular Lens Implantation; Intraocular lens implant device; Iris; Iris (Eye); Iritis; Joint Dislocation; Len, Crystalline; Len, Eye; Length; Lens; Lens of Eye; Lens, Crystalline; Lens, Eye; Lenses; Lenses, Intraocular; Location; Long-Term Effects; MR Imaging; MR Tomography; MRI; Magnetic Resonance Imaging; Magnetic Resonance Imaging Scan; Man (Taxonomy); Man, Modern; Marketing; Measurement; Mechanics; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; Meteorological Climate; Methods; Methods and Techniques; Methods, Other; Modeling; Myopia; NMR Imaging; NMR Tomography; Nearsightedness; Nearsightednesses; Nuclear Magnetic Resonance Imaging; Ocular Lens; Operation; Operative Procedures; Operative Surgical Procedures; Optics; Patients; Phase; Population; Position; Positioning Attribute; Post-Operative; Postoperative; Postoperative Complications; Postoperative Period; Presbyopia; Presbyopias; Pressure; Pressure- physical agent; Principal Investigator; Procedures; Process; Programs (PT); Programs [Publication Type]; Pupil; Refractive Disorders; Refractive Errors; Removal; Reporting; Resolution; Rest; Safety; Science of Anatomy; Senescence; Sight; Silicones; Simulate; Software; Structure; Surgical; Surgical Interventions; Surgical Procedure; Surgical Removal; Syndrome; Teaching; Techniques; Time; Tissue Growth; Tissues; Treatment Side Effects; Uveitis; Vision; Visual Acuity; Visual Contrast Sensitivity; Visualization; Wound Healing; Wound Repair; Zeugmatography; anatomy; anterior chamber; capsule (pharmacologic); cataract surgery; cataractogenesis; cataractous lenses; climatic; clinical data repository; clinical data warehouse; computer program/software; corneal endothelial; data repository; design; designing; eye disorder; eye refraction disorder; glaucomatous; haptics; healing; hemorrhage anterior chamber eye; imaging; implant placement; implant procedure; improved; in vivo; interest; irritation; lens; models and simulation; near vision; ontogeny; ophthalmopathy; premature; pressure; programs; public health relevance; relational database; resection; senescent; side effect; statistics/biometry; surgery; therapy adverse effect; tissue repair; tool; treatment adverse effect; volunteer