In the past three decades intraocular lens (IOL) replacement has become the standard of care for treating cataracts, the world's leading cause of blindness. Tremendous advances have been made both in the design of the IOL and in the surgical procedure. The newest lenses can correct refractive errors and some lenses are beginning to appear that have the potential to restore accommodation. Extracapsular cataract surgery (ECCS) is the most common ophthalmologic procedure performed worldwide; during this procedure the old lens is removed from the capsular bag either intact or after emulsification, and an artificial IOL is inserted into the capsular bag. In spite of these advances, ECCS is not without its problems. A number of patients develop serious infections (endophthalmitis) and a large percentage of patients develop significant post surgical inflammation. This project is focused on increasing access to care by radically reducing the associated costs and incidence of cataract surgical complications through the development of a simple and inexpensive drug delivery system with two distinct components which the physician implants at the time of surgery. One bead-shaped device will integrate dexamethasone for the prevention of inflammation. The other bead is loaded with an antibiotic (ofloxacin) for the prevention of postsurgical infection. By delivering the two medications in separate beads, the physician will maintain flexibility in customizing patient care. Eye drops, the current standard-of-care, generally achieve less than 1% penetration into the eye, and present significant compliance issues due to the multiple daily doses required. Ocular implants pre-loaded with drug can release a constant amount of medication over pre-set treatment periods, remove compliance issues and bypass the physiological barriers to the eye. The scope of this trial encompasses the creation of a separate drug delivery device for each medication and an extensive in vitro examination of their individual bioactivity and release profiles. An in vivo verification of the device safety and efficacy will then be conducted in New Zealand White rabbits over a period of 42 days. Inson's overall objective is the commercialization of two revolutionary drug eluting beads, one of which contains an antibiotic and the other an anti-inflammatory drug. When used together they will radically increase patient access to care, especially in underdeveloped areas of the world. We believe the devices will also reduce cataract surgical complications as well as their associated costs. The work we propose is a critical step on the way towards achieving this important goal. (PUBLIC HEALTH RELEVANCE STATEMENT): Cataract surgery, in which the cataractous natural lens is replaced with an artificial intraocular lens, is the most common ophthalmologic procedure worldwide with an estimated 38 million procedures performed annually (WHO estimate). While tremendous advances have been made in the lenses and the procedure, significant issues remain - cost of the surgery and post-op care, patient compliance with post-surgical care, infection, secondary cataracts and post-surgical inflammation. The development of drug eluting intraocular beads that eliminate the primary complications of infection and inflammation will both improve surgical outcomes and reduce the overall cost of care, making IOL replacement available to more patients (particularly in rural and underdeveloped areas).
Thesaurus Terms: "(+/-)-9-Fluoro-2,3-Dihydro-3-Methyl-10-(4-Methyl-1-Piperazinyl)-7- -Oxo-7h-Pyrido(1,2,3-De)- -1,4-Benzoxazine-6-Carboxylic Acid; (11beta,16alpha)-9-Fluoro-11,17,21-Trihydroxy-16-Methylpregna-1,4-Diene-3,20-Dione; 1-Dehydro-16alpha-Methyl-9alpha-Fluorohydrocortisone; 16alpha-Methyl-9alpha-Fluoro-1,4-Pregnadiene-11beta,17alpha,21-Triol-3,20-Dione; 16alpha-Methyl-9alpha-Fluoro-Delta1-Hydrocortisone; 16alpha-Methyl-9alpha-Fluoroprednisolone; 9alpha-Fluoro-11beta,17alpha,21-Trihydroxy-16alpha-Methylpregna-1,4-Diene-3,20-Dione; 9alpha-Fluoro-16alpha- Methylprednisolone; Aacidexam; Access To Care; Access To Health Care; Access To Healthcare; Accessibility Of Health Care; Address; Adexone; Adverse Effects; Africa; Aknichthol Dexa; Alba-Dex; Alin; Alin Depot; Alin Oftalmico; Ambene; Amplidermis; Anemul Mono; Animal Model; Animal Models And Related Studies; Anti-Inflammatories; Anti-Inflammatory Agents; Anti-Inflammatory; Antibiotic Agents; Antibiotic Drugs; Antibiotics; Antiinflammatories; Antiinflammatory Agents; Antimicotico; Aquapred; Area; Auxiloson; Availability Of Health Services; Azona; Baycuten; Baycuten N; Bioavailability; Biologic Availability; Biological Availability; Blindness; Body Tissues; Bypass; Caring; Cataract; Cataract Extraction; Chemicals; China; Compliance Behavior; Complication; Corson; Cortidexason; Cortisumman; Decacort; Decadrol; Decadron; Decalix; Decameth; Decasone R.P.; Dectancyl; Deenar; Dekacort; Deltafluorene; Deronil; Desamethasone; Desameton; Developed Countries; Developed Nations; Development; Device Safety; Devices; Dex-4; Dexa-Mamallet; Dexa-Rhinosan; Dexa-Scheroson; Dexa-Sine; Dexace; Dexacortal; Dexacortin; Dexafarma; Dexafluorene; Dexalocal; Dexamecortin; Dexameth; Dexamethasone; Dexamethasonum; Dexamonozon; Dexapos; Dexinoral; Dexone; Dinormon; Dose; Drug Delivery; Drug Delivery Systems; Drug Interactions; Drug Targeting; Drug Targetings; Drug Usage; Drugs; Economics; Effectiveness; Endophthalmitis; Extracapsular; Eye; Eye Drops; Eyeball; Eyedrops; Fluoro-9alpha Methyl-16alpha Prednisolone; Fluorodelta; Fortecortin; Gammacorten; Goals; Health Services Accessibility; Hexadecadrol; Hexadrol; Inflm; Implant; In Vitro; Incidence; India; Individual; Industrialized Countries; Industrialized Nations; Infection; Inflammation; Intraocular Lens Implant Device; Lenses, Intraocular; Lifting; Lokalison-F; Loverine; Mainland China; Mammals, Rabbits; Medication; Methylfluorprednisolone; Millicorten; Miscellaneous Antibiotic; Modeling; Mymethasone; New Zealand; Ocasa; Ofloxacin; Operation; Operative Procedures; Operative Surgical Procedures; Ophthalmia; Orgadrone; Oryctolagus Cuniculus; Outcome; Patient Care; Patient Care Delivery; Patient Compliance; Patient Cooperation; Patients; Penetration; Pharmaceutic Preparations; Pharmaceutical Preparations; Physicians; Physiologic; Physiologic Availability; Physiological; Post-Operative; Postoperative; Postoperative Period; Predni-F; Pregna-1,4-Diene-3,20-Dione, 9-Fluoro-11,17,21-Trihydroxy-16-Methyl-, (11beta,16alpha)-; Prevention; Procedures; Productivity; Rabbit, Domestic; Rabbits; Refractive Disorders; Refractive Errors; Research; Rural; Safety; Series; Shapes; Side; Spersadex; Spersadox; Surgical; Surgical Interventions; Surgical Procedure; Surgical Complication; Testing; Time; Tissues; Treatment Compliance; Treatment Period; Treatment Side Effects; Visual Acuity; Visumetazone; Who; Work; World Health Organization; Access To Services; Access To Treatment; Auricularum; Availability Of Services; Bioavailability Of Drug; Blind; Cataract Surgery; Cataractogenesis; Cataractous Lenses; Commercialization; Compliance Cooperation; Cost; Design; Designing; Dosage; Drug Development; Drug Use; Drug/Agent; Economic Impact; Experience; Eye Refraction Disorder; Flexibility; Health Care Availability; Health Care Service Access; Health Care Service Availability; Health Services Availability; Healthcare Access Availability; Healthcare Service Access; Healthcare Service Availability; Improved; In Vitro Model; In Vivo; Lens; Model Organism; Patient Adherence; Prevent; Preventing; Public Health Relevance; Rural Area; Secondary Infection; Side Effect; Standard Of Care; Surgery; Therapy Adverse Effect; Therapy Compliance; Therapy Cooperation; Treatment Adverse Effect; Treatment Days; Treatment Duration"
