Presentation on theme: "TECHNOLOGY & CLINICAL SUMMARY"— Presentation transcript:
1 TECHNOLOGY & CLINICAL SUMMARY [24.Feb.2010]Daniel S. Durrie, MDOverland Park, Kansas, USA
2 RevitalVision represents a new category in vision improvement COMPANY OVERVIEWRevitalVision represents a new category in vision improvementNon-invasive technology that enhances eyesight neurologicallyThe company's U.S. launch is focused on improving outcomes after intraocular lens implantation and refractive surgeryAverage improvement of2 lines visual acuity100% in contrast sensitivity
3 COMPANY OVERVIEWThis computer-based neural vision therapy (NVT) is clinically and scientifically proven to improve the vision outcomes for:Amblyopiapost-cataractpost-refractive (LASIK)presbyopianight visionlow myopessports vision patientsLow Vision
4 HISTORY OF REVITALVISION The NVT technology was originally developed in Israel where the company was established in 1999.US FDA 510(K) approval given in August 2001 for the treatment of adult amblyopia (age 9-55).The company, relocated to Singapore in 2004 under the company name NeuroVision, Inc.due to government interest in the treatment of pediatric myopia in the Asian Pacific Region.
5 HISTORY OF REVITALVISION Has treated more than 4,000 patients in Europe, the U.S., and Asia.In 2009, NeuroVision was purchased by RevitalVision LLC, and operations were relocated to the United States, in Lawrence, Kansas.The technology has successfully conducted U.S. clinical trials that replicate the international results.
6 RevitalVision Concept =OPTICS (EYE)+NEURAL (BRAIN)Vision aids likeSpectacles and contact lensesNeuroVisionRevitalVision optimizes the visual processing in the brainNeurologically Retrains the Brain to See Better
7 PRESENT PRODUCT OFFERINGS IN THE USA PRODUCTS READY FOR MARKET: Amblyopia, Low Vision (Macular Degeneration), Low Myopia, Sports Vision, Night Driving
8 SCIENTIFIC PREMISESoftware-based, interactive system tailored and continuously adaptive to individual visual abilitiesProbes specific neuronal interactions to induce improvement of contrast sensitivity function (CSF) due to a reduction of noise and increase in signal strengthCompensates for blurred inputs coming from the retina by enhancing neural processing
9 SCIENTIFIC BUILDING BLOCKS Neuronal lateral interactionsGabor patch visual stimulusUse of flankersPerceptual learningBrain plasticity
10 NEURONAL LATERAL INTERACTIONS Individual neurons respond to:Precise locationOrientationSpatial frequencyNeuronal Interactions:Result in excitation or suppressionOccur at multiple levels of the visual pathwayRevitalVision enhances these lateral interactions
11 GABOR PATCHGabor Patches developed by Nobel Prize winning physicist, Dennis GaborWidely used in the field of visual neuroscience to describe the shape of receptive fields of neurons in the primary visual cortexThey represent the most effective stimulation of the primary visual cortex11
12 Target Flankers USE OF FLANKERS First DisplaySecond DisplayTargetFlankersThe software measures the contrast threshold of a Gabor target with the presence of flankersThe patient is exposed to two short displays in succession and the patient identifies which display contains three Gabors12
13 SCIENTIFIC BASIS OF FLANKERS & COLLINEARITY Lateral masking and collinear alignment of the Gabor patches improve neuronal efficiency and improvement of CSF by reducing the noise to signal ratio of neural activity in the primary visual cortex.Animal model showed increased visual cortex stimulation with collinearly oriented flankers (spatial frequency patterns are oriented in a linear fasion).11. Polat, et al. Collinear stimuli regulate visual responses depending on cell's contrast threshold.Nature. 1998;391:
15 Visual acuity improvement in adults with amblyopia has been reported BRAIN PLASTICITYNeural plasticity relates to the ability of the nervous system to adapt to changed conditionsVisual acuity improvement in adults with amblyopia has been reportedAfter prolonged patchingAfter the better eye’s vision has been degraded by age related macular degeneration, cataract or trauma
16 NEUROPROCESSING BASICS The brain pools responses across many neurons to average out noisy activity of single cellsimproving signal-to-noise ratio, leading to improved visual performance and acuityThe noise of individual neurons can be brought under experimental control by appropriate choice of stimulus conditionsContrast sensitivity at low levels can be increased dramatically through control of stimulus parameters16
17 NEUROPROCESSING BASICS Hubel et al., Receptive fields of single neurons in the cat’s striate cortex. J Physiol 1959,148:Changes in electrical activity in a cat cortex were examined in response to visual stimulationSpecific neurons in the primary visual cortex respond to specific visual stimulationsThe main parameters are location, orientation and spatial frequency of the visual stimulus.In 1981 Hubel & Wiesel received Nobel Prize for this discovery, which led to understanding of visual processing
18 NEUROPROCESSING BASICS Polat, et al. Collinear stimuli regulate visual responses depending on cell's contrast threshold. Nature. 1998;391:Demonstrated a direct correlation between different contrast levels and single neuron response in the primary visual cortexThere is neural plasticity in the adult brainPerceptual learning can be modifiedVision can improve by perceptual learning technique by practicing a series of controlled and repetitive specific visual tasks.The vision improvement reflects improved contrast sensitivity.
19 CLINICAL IMPLEMENTATION Step 1: ECP VA data creates baseline for RevitalVision treatmentStep 2: Patient completes two sessions; neural performance analyzedStep 3:20-40 customized sessions completed at home via internet; darkened room, five feet from screenStep 4: Treatment completed. Vision performance maximizedTREATMENT FLOWResults sent to server. Sessions adjust to progress, improving neural performance
20 COMPUTERIZED EVALUATION SESSIONS NeuroVision Training03/24/2008COMPUTERIZED EVALUATION SESSIONSAfter an Orientation Session the patient undergoes two computerized Evaluation SessionsThe Computerized Evaluation sessions identify the patient’s specific visual abilities and inefficiencies and define individual parameters that will affect the patient’s treatment plan20
21 NeuroVision Training03/24/2008TREATMENT SESSIONSTypically patient should undergo 30 sessions during this phase (40 for amblyopia).The patient should perform on average three (3) treatment sessions per week.Visit interruptions longer than two (2) weeks on aggregate are discouraged.Three (3) periodic examination are recommended along the treatment sessions to monitor and feedback patient progress.Amblyopic patients – should prescribed best corrected eyewear before baseline examination, and instructed to wear glasses/contact lenses through the entire treatment period.In non amblyopic patients - as progress is made, the refraction of the training glasses (previously prescribed to the patient) might change.21
22 NeuroVision Training03/24/2008END OF TREATMENTPatient will terminate the treatment sequence after 30 sessions (40 for Amblyopia)Following the end of treatment, the patient should be scheduled for End of Treatment examinationThe End of Treatment Examination is a repetition of the Baseline examination22
23 GUIDELINE FOR BEST RESULTS Motivation, consistency and compliance are key for achieving best resultsMake your best efforts to concentrate and achieve the best performance during each sessionPerform RevitalVision sessions at the time of day you are most alert (Not late night when sleepy)Perform RevitalVision sessions 3 times a weekBe aware of the quality of your vision throughout the course of treatment. Experience your vision improvement during daily activitiesUse your glasses less as vision improves (non amblyopic)
24 Polat U, Naim TM, Belkin M, Sagi D. PNAS 2004;101:17:6692-6697. CLINICAL RESEARCH SUMMARYPolat U, Naim TM, Belkin M, Sagi D. PNAS 2004;101:17:Polat et al. studied 54 adult amblyopic patients who were randomized to amblyopic NVT treatment or a placebo vision-training program.Pre treatment visual acuity in both study arms was 0.42 logMAR, and this improved by 2.5 lines to 20/30 in the NVT treatment group, with no improvement in the control group. (statistically significant )This increase in acuity was corroborated by a commensurate increase in CSF to within the normal range.These improvements in acuity and CSF were sustained after 12 months.
25 CLINICAL RESEARCH SUMMARY Tan D, Fong A. Efficacy of neural vision therapy to enhance contrast sensitivity function and visual acuity in low myopia. J Cataract Refract Surg. 2008;Apr;34(4):570-7.D. Tan and A. Fong conducted a randomized controlled trial evaluating the efficacy of NVT in low myopia.The results showed statistically significant difference in unaided visual acuity between the masked and treatment groupsMean improvement of 2.6 logMar lines of distance uncorrected visual acuity for low myopes,2.0 logMar lines near unaided visual acuity for early presbyopes.Results suggest evidence of efficacy and safety with NVT treatment in improving visual acuity and contrast sensitivity function in adult low myopes.
26 CLINICAL RESEARCH SUMMARY Durrie D, McMinn PS. Computer-based primary visual cortex training for treatment of low myopia and early presbyopia. Trans Am Ophthalmol Soc. 2007;105:132-8D. Durrie and P. McMinn evaluated 11 patients with low myopia (up to -1.75D) and 18 with early presbyopia (up to +2.50D Add) in 2 clinical sites who underwent NVT.Control group performed only visual examinationsLow myopia groupTreatment group achieved a mean improvement of 2.2 logMAR lines in UAVA.CSF improved at all spatial frequencies.Control patients did not shown any significant change in vision.Early presbyopia groupMean improvement of 2.2 logMAR lines in near UCDVA.Near UCSF improved at all spatial frequencies.The control patients did not shown any significant change in vision.Mean refractive error in all groups remained unchanged after treatment.
27 CLINICAL RESEARCH SUMMARY Lim KL, Fam HB. NeuroVision treatment for low myopia following LASIK regression. J Refract Surg Apr;22(4):406-8.Lim et al. reported a single case of NVT for the treatment low myopic regression five years after bilateral myopic LASIK.The patient improved 2.8 lines in the right eye and 1.6 lines in the left eye following NVT.
28 Tan D, Fong A 2007, Unpublished Data CLINICAL RESEARCH SUMMARYTan D, Fong A 2007, Unpublished DataTan et al. reported clinical data for low myopes and presbyopes after completion of the NVT training.After treatment there was a mean improvement of 2.8 logMar lines in distance UCVA for 55 low myopesMean improvement of 1.6 logMar lines in near UCVA for the 41 presbyopes (age year old)The improvements were shown to be retained for at least 12 months.
29 CLINICAL RESEARCH SUMMARY Durrie, D. Slade, S Unpublished data Waring IV GO, Durrie DS. NeuroLASIK – Can surgeons improve LASIK outcomes by training the visual cortex? Cataract and Refractive Surgery Today, Aug 2008;52-53.D. Durrie and S. Slade conducted a prospective, randomized, multicenter placebo controlled study comparing neural vision therapy (NVT) after LASIK (“NeuroLASIK”) to sham treatment (video game) following LASIK in 98 eyes.Treatment groupUCDVA improved 0.8 Snellen lines79% improvement in contrast sensitivity function (CSF)Control groupUCDVA 0.28 line improvement52% improvement in CSFPatients who were worse than 20/20 after LASIK with NVTUCDVA improved 1.56 Snellen lines90% improvement in CSFControl group worse than 20/20 after LASIK with sham treatmentUCDVA improved 0.34 lines47% improvement in CSFThe results suggested that patients who had worse vision improved more and that perhaps there is a cortical limit to how much a patient can improve.
30 Hunkeler J, Lindstrom D. Unpublished Data 2009 CLINICAL RESEARCH SUMMARYHunkeler J, Lindstrom D. Unpublished Data 2009J. Hunkeler and D. Lindstrom prospectively evaluated the efficacy of computer based primary NVT in improving vision after aspheric monofocal, multifocal and accommodative Intraocular Lens (IOL) implantation of 5 different IOL styles in 60 eyes.After CVT, mean improvement in UCDVA and UCNVA for the entire group was 1.3 and 1.0 lines respectivelyMean improvement in distance and near CSF were 223% and 197% respectively.After CVT, mean improvement in UCDVA and UCNVA wereCrystalens accommodative IOL (N=6) was 0.3 and 1.7Alcon Restor (N=10) was 1.5 and 1.1AMO ReZoom (N=24) was 1.4 and 0.7Alcon Acrysof monofocal (N=10) was 1.3 and 0.7AMO Technis monofocal (N=10) was 1.4 and 1.3 lines respectively.
31 Adult Amblyopia Trial: 2000-2001 RESULTS OF EARLY STUDIESAdult Amblyopia Trial:Control GroupTreatment Group1044Number of subjects38.2 ± 9.435.0 ± 13.0Average Age0.41 ± 0.12(20/51)0.41 ± 0.14Mean BCVA in Amblyopic EyeBefore Treatment in logMar0.17 ± 0.14(20/30)After Treatment in logMarN/A0.21 ± 0.14(20/33)1 Year After Treatment in logMarMean 2.4 Lines Improvement in the Treatment GroupMean 0.0 Lines Improvement in the Control GroupMinor Regression 1 Year After Treatment End – 85% of the Mean Improvement was Maintained* FDA approved for Adult Amblyopia31
32 Adult Amblyopia Trial: 2000-2001 RESULTS OF EARLY STUDIESAdult Amblyopia Trial:BCVA=20/30BCVA=20/33BCVA=20/5112 Months Post TreatmentAt End of TreatmentBefore Treatment StartContrast Sensitivity Improved at All FrequenciesContrast Sensitivity Improved in average more than 100%After Treatment Contrast Sensitivity Improved into the Normal RangeContrast Sensitivity Maintained 1 Year After Treatment End (Even Slightly Better Compare to Treatment End)32
33 Low Myopia, Singapore Eye Research Institute, 2003 - 2004 RESULTS OF EARLY STUDIESLow Myopia, Singapore Eye Research Institute,Treatment Group20Number of subjects34.0 (16 to 55)Average Age-1.08D (0 to -1.75)Mean Cycloplegic Spherical Equivalence Before Treatment-1.06D (0 to -1.75)Mean Cycloplegic Spherical Equivalence After Treatment0.31 ± 0.03(20/41)Mean Unaided VABefore Treatment in logMar0.10 ± 0.03(20/25)After Treatment in logMar0.12 ± 0.03(20/26)1 Year After Treatment in logMarMean 2.1 Lines Improvement in the Treatment GroupMinor Regression 1 Year After Treatment End – 90% of the Mean Improvement was Maintained33
34 Low Myopia, Singapore Eye Research Institute 2003 - 2004 RESULTS OF EARLY STUDIESLow Myopia, Singapore Eye Research InstituteUCVA=20/25UCVA=20/26UCVA=20/4112 Months Post TreatmentAt End of TreatmentBefore Treatment StartContrast Sensitivity Improved at All FrequenciesContrast Sensitivity Improved in average approximately 100%After Treatment Contrast Sensitivity Improved Well Within the Normal RangeContrast Sensitivity Maintained 1 Year After Treatment End34
35 Low Myopia and Post Refractive Surgery Commercial Data, 2004-2005 RESULTS OF EARLY STUDIESLow Myopia and Post Refractive Surgery Commercial Data,Post Refractive SurgeryLow Myopia35259Number of subjects30 (7-55)Average Age-1.14D ± 0.11-1.34D ± 0.03Mean Manifest Spherical Equivalence Before Treatment-1.09D ± 0.12-1.20D ± 0.04Mean Manifest Spherical Equivalence After Treatment0.32 ± 0.03(20/42)0.43 ± 0.01(20/54)Mean Unaided VABefore Treatment in logMar0.10 ± 0.02(20/25)0.17 ± 0.01(20/30)After Treatment in logMarN/A0.21 ± 0.01(20/33)1 Year After Treatment in logMar (48 subjects)Mean 2.6 Lines Improvement in the Low Myopia Treatment GroupMean 2.2 Lines Improvement in the Post Refractive Surgery Treatment GroupMinor Regression 1 Year After Treatment End in the Low Myopia Treatment Group – 85% of the Mean Improvement was Maintained35
36 Low Myopia Post Refractive Surgery Commercial Data, 2004-2005 RESULTS OF EARLY STUDIESLow Myopia Post Refractive Surgery Commercial Data,Low MyopiaPost Refractive SurgerySpatial FrequencyUCVA=20/28UCVA=20/54UCVA=20/30UCVA=20/33UCVA=20/25UCVA=20/44UCVA=20/42Contrast Sensitivity Improved at All Frequencies in Both GroupsContrast Sensitivity Improved in average more than 100% in Both GroupsAfter Treatment Contrast Sensitivity Improved Well Within the Normal Range in Both GroupsContrast Sensitivity Maintained 1 Year After Treatment End, with Minor Regression12 Months Post TreatmentAt End of TreatmentBefore Treatment Start36
37 Presbyopia, European Trial, 2005 RESULTS OF EARLY STUDIESPresbyopia, European Trial, 2005Treatment Group41Number of subjects46.37 ± 0.52 (41-55)Average Age+1.40D ± 0.05DMean Near Addition0.33 ± 0.04(20/43)Mean Unaided VABefore Treatment in logMar0.17 ± 0.04(20/29)After Treatment in logMarMean 1.6 Lines Improvement in the Presbyopia Treatment Group37
38 Presbyopia, European Trial, 2005 RESULTS OF EARLY STUDIESPresbyopia, European Trial, 2005Spatial FrequencyUCNVA=20/35UCNVA=20/54UCNVA=20/29UCNVA=20/4312 Months Post TreatmentAt End of TreatmentBefore Treatment StartContrast Sensitivity Improved at All Frequencies in the Presbyopia Treatment GroupAfter Treatment Contrast Sensitivity Improved into the Normal Range38
39 Visual Improvement and Functional Outcome RESULTS OF EARLY STUDIESVisual Improvement and Functional OutcomeVisual Acuity ImprovementContrastSensitivityImprovementRetention of Improvement1 Year PostTreatmentMainFunctionalOutcomeMyopiaUp to -1.50D2.6 Lines ETDRS (Distance)Above 100% inAll Frequencies85% of the ImprovementDecreaseDependency onSpectaclesPresbyopiaUp to +1.5D2.0 Lines ETDRS(Near)Average Of100% inDelay The Need for Reading GlassesPostRefractiveSurgery2.3 Lines ETDRS(Distance)IncreasedQuality ofFunctional VisionAmblyopia2.5 Lines ETDRSQuality of Vision,ImprovedBinocularity39
40 New Treatment: “Physical Therapy for Vision” INCORPORATING IN PRACTICENew Treatment: “Physical Therapy for Vision”RevitalVision enhance surgical outcomesLittle or no interruption to current practice proceduresIt’s as easy as “writing a prescription”Therapy can be done anytime, post surgery
41 INCORPORATING IN PRACTICE Cataract and LASIK products can be offered to patientsBundle with surgeryOffer premium packageInclude as part of standard of care (premium practices)Minimum extra intervention by doctor’s officeAmblyopia: the only clinically proven treatment to improve vision for adult amblyopic patientsOther products: (amblyopia, presbyopia, low myopia, etc.)Offer to suitable candidates
42 INCORPORATING IN PRACTICE Therapeutic opportunity for reduced contrast sensitivity as age and cataract surgery contribute to decline in CSFEmpowers the patient to improve their own visual outcomesAdditional tool for patient satisfactionMake patient’s vision betterEmpower patients to improve with their home “physical therapy for vision.”Minimum changes necessary at practice levelAll technical needs are handled by RevitalVision (distributors).Patient progress monitored by RevitalVisonPotential source for additional revenue for physician practices
43 INCORPORATING IN PRACTICE Offer RevitalVision at Surgeon OfficeBundle with cataract surgeryOffer premium package – up chargeInclude as part of standard of care (premium practices)Referring OptometristOffer RevitalVision to patient at 3 or 6 month follow-upAll Post Surgical PatientsPatient undergo first guided training session at the clinic and the rest are done at home. Any technical issues are handled directly by RevitalVision (local distributors)
44 SUMMARY Novel approach to improvement in visual function “Physical therapy for vision”Computer based primary cortex vision trainingFounded on proprietary cortical visual science therapeutic strategiesAverage improvement of 2 lines visual acuity and 100% in contrast sensitivityNon-invasive and safeMultiple treatment indications offerings including amblyopia, post IOL implant therapy, post refractive surgery, presbyopia, Low Myopia, Low Vision, Sport Vision.Future product offerings in development44
45 CONTACT INFORMATIONRevitalVision, LLCNeuroVision/RevitalVision distributors:ISRAEL- Talshir Medical Technologies Ltd.Turkey- NoroVizyon Ltd.Greece – Vitamia Medical Ltd.