![TECHNOLOGY & CLINICAL SUMMARY [24. Feb. 2010] Daniel S. Durrie, MD Overland Park, Kansas,](https://present5.com/presentation/88b8ac3660e872ef4a5bddb5980e7f52/image-1.jpg "TECHNOLOGY & CLINICAL SUMMARY [24. Feb. 2010] Daniel S. Durrie, MD Overland Park, Kansas,")
TECHNOLOGY & CLINICAL SUMMARY [24. Feb. 2010] Daniel S. Durrie, MD Overland Park, Kansas, USA 3/15/2018 12. 10. 2009 12. 10. 09 1 1 www. revitalvision. com
COMPANY OVERVIEW § Revital. Vision represents a new category in vision improvement § Non-invasive technology that enhances eyesight neurologically § The company's U. S. launch is focused on improving outcomes after intraocular lens implantation and refractive surgery § Average improvement of Ø 2 lines visual acuity Ø 100% in contrast sensitivity 3/15/2018 12. 10. 2009 12. 10. 09 2 2 www. revitalvision. com
COMPANY OVERVIEW § This computer-based neural vision therapy (NVT) is clinically and scientifically proven to improve the vision outcomes for: Ø Ø Ø Ø Amblyopia post-cataract post-refractive (LASIK) presbyopia night vision low myopes sports vision patients Low Vision 3/15/2018 12. 10. 2009 12. 10. 09 3 3 www. revitalvision. com
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 Neuro. Vision, Inc. Ø due to government interest in the treatment of pediatric myopia in the Asian Pacific Region. 3/15/2018 12. 10. 2009 12. 10. 09 4 4 www. revitalvision. com
HISTORY OF REVITALVISION § Has treated more than 4, 000 patients in Europe, the U. S. , and Asia. § In 2009, Neuro. Vision was purchased by Revital. Vision 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. 3/15/2018 12. 10. 2009 12. 10. 09 5 5 www. revitalvision. com
Revital. Vision Concept VISION = OPTICS (EYE) + NEURAL (BRAIN) + Vision aids like Spectacles and contact lenses Neuro. Vision § Revital. Vision optimizes the visual processing in the brain § Neurologically Retrains the Brain to See Better 3/15/2018 12. 10. 2009 12. 10. 09 6 6 www. revitalvision. com
PRESENT PRODUCT OFFERINGS IN THE USA PRODUCTS READY FOR MARKET: Amblyopia, Low Vision (Macular Degeneration), Low Myopia, Sports Vision, Night Driving 3/15/2018 12. 10. 2009 12. 10. 09 7 7 www. revitalvision. com
SCIENTIFIC PREMISE § Software-based, interactive system tailored and continuously adaptive to individual visual abilities § Probes specific neuronal interactions to induce improvement of contrast sensitivity function (CSF) due to a reduction of noise and increase in signal strength § Compensates for blurred inputs coming from the retina by enhancing neural processing 3/15/2018 12. 10. 2009 12. 10. 09 8 8 www. revitalvision. com
SCIENTIFIC BUILDING BLOCKS § Neuronal lateral interactions § Gabor patch visual stimulus § Use of flankers § Perceptual learning § Brain plasticity 3/15/2018 12. 10. 2009 12. 10. 09 9 9 www. revitalvision. com
NEURONAL LATERAL INTERACTIONS § Individual neurons respond to: Ø Precise location Ø Orientation Ø Spatial frequency § Neuronal Interactions: Ø Result in excitation or suppression Ø Occur at multiple levels of the visual pathway Ø Revital. Vision enhances these lateral interactions 3/15/2018 12. 10. 2009 12. 10. 09 10 10 www. revitalvision. com
GABOR PATCH § Gabor Patches developed by Nobel Prize winning physicist, Dennis Gabor § Widely used in the field of visual neuroscience to describe the shape of receptive fields of neurons in the primary visual cortex § They represent the most effective stimulation of the primary visual cortex 3/15/2018 12. 10. 2009 12. 10. 09 11 11 www. revitalvision. com
USE OF FLANKERS First Display Second Display Target Flankers § The software measures the contrast threshold of a Gabor target with the presence of flankers § The patient is exposed to two short displays in succession and the patient identifies which display contains three Gabors 3/15/2018 12. 10. 2009 12. 10. 09 12 12 www. revitalvision. com
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). 1 1. Polat, et al. Collinear stimuli regulate visual responses depending on cell's contrast threshold. Nature. 1998; 391: 580 -4. 3/15/2018 12. 10. 2009 12. 10. 09 13 13 www. revitalvision. com
MANIPULATION OF GABOR STIMULUS & FLANKERS Spatial Frequency Local Orientation Contrast Global Orientation Target-Flankers Separation Target Displacement 3/15/2018 12. 10. 2009 12. 10. 09 14 14 www. revitalvision. com
BRAIN PLASTICITY § Neural plasticity relates to the ability of the nervous system to adapt to changed conditions § Visual acuity improvement in adults with amblyopia has been reported Ø After prolonged patching Ø After the better eye’s vision has been degraded by age related macular degeneration, cataract or trauma 3/15/2018 12. 10. 2009 12. 10. 09 15 15 www. revitalvision. com
NEUROPROCESSING BASICS § The brain pools responses across many neurons to average out noisy activity of single cells Ø improving signal-to-noise ratio, leading to improved visual performance and acuity § The noise of individual neurons can be brought under experimental control by appropriate choice of stimulus conditions § Contrast sensitivity at low levels can be increased dramatically through control of stimulus parameters 3/15/2018 12. 10. 2009 12. 10. 09 16 16 www. revitalvision. com
NEUROPROCESSING BASICS Hubel et al. , Receptive fields of single neurons in the cat’s striate cortex. J Physiol 1959, 148: 574 -591 § Changes in electrical activity in a cat cortex were examined in response to visual stimulation § Specific neurons in the primary visual cortex respond to specific visual stimulations § The 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 3/15/2018 12. 10. 2009 12. 10. 09 17 17 www. revitalvision. com
NEUROPROCESSING BASICS Polat, et al. Collinear stimuli regulate visual responses depending on cell's contrast threshold. Nature. 1998; 391: 580 -4. § Demonstrated a direct correlation between different contrast levels and single neuron response in the primary visual cortex § There is neural plasticity in the adult brain § Perceptual learning can be modified Ø Vision can improve by perceptual learning technique by practicing a series of controlled and repetitive specific visual tasks. Ø The vision improvement reflects improved contrast sensitivity. 3/15/2018 12. 10. 2009 12. 10. 09 18 18 www. revitalvision. com
CLINICAL IMPLEMENTATION TREATMENT FLOW Step 1: Step 2: Step 4: ECP VA data creates baseline for Revital. Vision treatment Patient completes two sessions; neural performance analyzed Treatment completed. Vision performance maximized 3/15/2018 12. 10. 2009 12. 10. 09 Step 3: 20 -40 customized sessions completed at home via internet; darkened room, five feet from Results sent to screen server. Sessions adjust to progress, improving neural performance 19 19 www. revitalvision. com
COMPUTERIZED EVALUATION SESSIONS § After an Orientation Session the patient undergoes two computerized Evaluation Sessions § The Computerized Evaluation sessions identify the patient’s specific visual abilities and inefficiencies and define individual parameters that will affect the patient’s treatment plan 3/15/2018 12. 10. 2009 12. 10. 09 20 20 www. revitalvision. com
TREATMENT SESSIONS § Typically 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. 3/15/2018 21 3/15/2018 § 12. 10. 2009 12. 10. 09 21 www. revitalvision. com
END OF TREATMENT § Patient 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 examination § The End of Treatment Examination is a repetition of the Baseline examination 3/15/2018 12. 10. 2009 12. 10. 09 22 22 www. revitalvision. com
GUIDELINE FOR BEST RESULTS § Motivation, consistency and compliance are key for achieving best results § Make your best efforts to concentrate and achieve the best performance during each session § Perform Revital. Vision sessions at the time of day you are most alert (Not late night when sleepy) § Perform Revital. Vision sessions 3 times a week § Be aware of the quality of your vision throughout the course of treatment. Experience your vision improvement during daily activities § Use your glasses less as vision improves (non amblyopic) 3/15/2018 12. 10. 2009 12. 10. 09 23 23 www. revitalvision. com
CLINICAL RESEARCH SUMMARY Polat U, Naim TM, Belkin M, Sagi D. PNAS 2004; 101: 17: 6692 -6697. § Polat et al. studied 54 adult amblyopic patients who were randomized to amblyopic NVT treatment or a placebo visiontraining program. § Pre treatment visual acuity in both study arms was 0. 42 log. MAR, 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. 3/15/2018 12. 10. 2009 12. 10. 09 24 24 www. revitalvision. com
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 groups Ø Mean improvement of 2. 6 log. Mar lines of distance uncorrected visual acuity for low myopes, Ø 2. 0 log. Mar 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. 3/15/2018 12. 10. 2009 12. 10. 09 25 25 www. revitalvision. com
CLINICAL RESEARCH SUMMARY Durrie D, Mc. Minn PS. Computer-based primary visual cortex training for treatment of low myopia and early presbyopia. Trans Am Ophthalmol Soc. 2007; 105: 132 -8 § D. Durrie and P. Mc. Minn evaluated 11 patients with low myopia (up to -1. 75 D) and 18 with early presbyopia (up to +2. 50 D Add) in 2 clinical sites who underwent NVT. § Control group performed only visual examinations § Low myopia group Ø Treatment group achieved a mean improvement of 2. 2 log. MAR lines in UAVA. Ø CSF improved at all spatial frequencies. Ø Control patients did not shown any significant change in vision. § Early presbyopia group Ø Mean improvement of 2. 2 log. MAR lines in near UCDVA. Ø Near UCSF improved at all spatial frequencies. Ø The control patients did not shown any significant change in vision. § Mean refractive error in all groups remained unchanged after treatment. 3/15/2018 12. 10. 2009 12. 10. 09 26 26 www. revitalvision. com
CLINICAL RESEARCH SUMMARY Lim KL, Fam HB. Neuro. Vision treatment for low myopia following LASIK regression. J Refract Surg. 2006 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. 3/15/2018 12. 10. 2009 12. 10. 09 27 27 www. revitalvision. com
CLINICAL RESEARCH SUMMARY Tan D, Fong A 2007, Unpublished Data § Tan 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 log. Mar lines in distance UCVA for 55 low myopes § Mean improvement of 1. 6 log. Mar lines in near UCVA for the 41 presbyopes (age 41 -55 year old) § The improvements were shown to be retained for at least 12 months. 3/15/2018 12. 10. 2009 12. 10. 09 28 28 www. revitalvision. com
CLINICAL RESEARCH SUMMARY Durrie, D. Slade, S. 2008 Unpublished data Waring IV GO, Durrie DS. Neuro. LASIK – 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 (“Neuro. LASIK”) to sham treatment (video game) following LASIK in 98 eyes. Treatment group Ø UCDVA improved 0. 8 Snellen lines Ø 79% improvement in contrast sensitivity function (CSF) § Control group Ø UCDVA 0. 28 line improvement Ø 52% improvement in CSF § Patients who were worse than 20/20 after LASIK with NVT Ø UCDVA improved 1. 56 Snellen lines Ø 90% improvement in CSF § Control group worse than 20/20 after LASIK with sham treatment Ø UCDVA improved 0. 34 lines Ø 47% improvement in CSF The results suggested that patients who had worse vision improved more and that perhaps there is a cortical limit to how much a patient 29 improve. can 3/15/2018 § 3/15/2018 12. 10. 2009 12. 10. 09 29 www. revitalvision. com
CLINICAL RESEARCH SUMMARY Hunkeler J, Lindstrom D. Unpublished Data 2009 § J. 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 respectively § Mean improvement in distance and near CSF were 223% and 197% respectively. § After CVT, mean improvement in UCDVA and UCNVA were Ø Ø Ø Crystalens accommodative IOL (N=6) was 0. 3 and 1. 7 Alcon Restor (N=10) was 1. 5 and 1. 1 AMO Re. Zoom (N=24) was 1. 4 and 0. 7 Alcon Acrysof monofocal (N=10) was 1. 3 and 0. 7 AMO Technis monofocal (N=10) was 1. 4 and 1. 3 lines respectively. 3/15/2018 12. 10. 2009 12. 10. 09 30 30 www. revitalvision. com
RESULTS OF EARLY STUDIES Adult Amblyopia Trial: 2000 -2001 Treatment Group Control Group 44 10 Average Age 35. 0 ± 13. 0 38. 2 ± 9. 4 Mean BCVA in Amblyopic Eye Before Treatment in log. Mar 0. 41 ± 0. 14 (20/51) 0. 41 ± 0. 12 (20/51) Mean BCVA in Amblyopic Eye After Treatment in log. Mar 0. 17 ± 0. 14 (20/30) 0. 41 ± 0. 12 (20/51) Mean BCVA in Amblyopic Eye 1 Year After Treatment in log. Mar 0. 21 ± 0. 14 (20/33) N/A Number of subjects * FDA approved for Adult Amblyopia 3/15/2018 12. 10. 2009 12. 10. 09 31 31 www. revitalvision. com
RESULTS OF EARLY STUDIES Adult Amblyopia Trial: 2000 -2001 12 Months Post Treatment At End of Treatment BCVA=20/51 Before Treatment Start BCVA=20/30 BCVA=20/33 3/15/2018 12. 10. 2009 12. 10. 09 32 32 www. revitalvision. com
RESULTS OF EARLY STUDIES Low Myopia, Singapore Eye Research Institute, 2003 - 2004 Treatment Group Number of subjects Average Age 20 34. 0 (16 to 55) Mean Cycloplegic Spherical Equivalence Before Treatment -1. 08 D (0 to -1. 75) Mean Cycloplegic Spherical Equivalence After Treatment -1. 06 D (0 to -1. 75) Mean Unaided VA Before Treatment in log. Mar 0. 31 ± 0. 03 (20/41) Mean Unaided VA After Treatment in log. Mar 0. 10 ± 0. 03 (20/25) Mean Unaided VA 1 Year After Treatment in log. Mar 3/15/2018 12. 10. 2009 12. 10. 09 0. 12 ± 0. 03 (20/26) 33 33 www. revitalvision. com
RESULTS OF EARLY STUDIES Low Myopia, Singapore Eye Research Institute 2003 - 2004 12 Months Post Treatment At End of Treatment UCVA=20/41 Before Treatment Start UCVA=20/25 UCVA=20/26 3/15/2018 12. 10. 2009 12. 10. 09 34 34 www. revitalvision. com
RESULTS OF EARLY STUDIES Low Myopia and Post Refractive Surgery Commercial Data, 2004 -2005 Low Myopia Post Refractive Surgery 259 35 30 (7 -55) Mean Manifest Spherical Equivalence Before Treatment -1. 34 D ± 0. 03 -1. 14 D ± 0. 11 Mean Manifest Spherical Equivalence After Treatment -1. 20 D ± 0. 04 -1. 09 D ± 0. 12 Mean Unaided VA Before Treatment in log. Mar 0. 43 ± 0. 01 (20/54) 0. 32 ± 0. 03 (20/42) Mean Unaided VA After Treatment in log. Mar 0. 17 ± 0. 01 (20/30) 0. 10 ± 0. 02 (20/25) Mean Unaided VA 1 Year After Treatment in log. Mar 3/15/2018 (48 subjects) 0. 21 ± 0. 01 (20/33) N/A Number of subjects Average Age 12. 10. 2009 12. 10. 09 35 35 www. revitalvision. com
RESULTS OF EARLY STUDIES Low Myopia Post Refractive Surgery Commercial Data, 2004 -2005 Low Myopia Post Refractive Surgery UCVA=20/54 UCVA=20/42 UCVA=20/44 UCVA=20/30 UCVA=20/28 UCVA=20/25 UCVA=20/33 UCVA=20/30 Spatial Frequency 12 Months Post Treatment At End of Treatment 3/15/2018 12. 10. 2009 12. 10. 09 Before Treatment Start 36 36 www. revitalvision. com
RESULTS OF EARLY STUDIES Presbyopia, European Trial, 2005 Treatment Group Number of subjects Average Age Mean Near Addition 41 46. 37 ± 0. 52 (41 -55) +1. 40 D ± 0. 05 D Mean Unaided VA Before Treatment in log. Mar 0. 33 ± 0. 04 (20/43) Mean Unaided VA After Treatment in log. Mar 0. 17 ± 0. 04 (20/29) 3/15/2018 12. 10. 2009 12. 10. 09 37 37 www. revitalvision. com
RESULTS OF EARLY STUDIES Presbyopia, European Trial, 2005 12 Months Post Treatment At End of Treatment Before Treatment Start UCNVA=20/43 UCNVA=20/54 UCNVA=20/35 UCNVA=20/ 29 Spatial Frequency 3/15/2018 12. 10. 2009 12. 10. 09 38 38 www. revitalvision. com
RESULTS OF EARLY STUDIES Visual Improvement and Functional Outcome Visual Acuity Contrast Improvement Sensitivity Improvement Retention of Main Improvement Functional 1 Year Post Outcome Treatment Myopia Up to -1. 50 D 2. 6 Lines ETDRS Above 100% in (Distance) All Frequencies 85% of the Improvement Presbyopia Up to +1. 5 D 2. 0 Lines ETDRS (Near) Average Of 100% in All Frequencies Delay The Need for Reading Glasses Post Refractive Surgery 2. 3 Lines ETDRS (Distance) Above 100% in All Frequencies Increased Quality of Functional Vision Amblyopia 2. 5 Lines ETDRS (Distance) Above 100% in All Frequencies 3/15/2018 12. 10. 2009 12. 10. 09 85% of the Improvement Decrease Dependency on Spectacles Increased Quality of Vision, Improved Binocularity 39 39 www. revitalvision. com
INCORPORATING IN PRACTICE New Treatment: “Physical Therapy for Vision” § Revital. Vision enhance surgical outcomes § Little or no interruption to current practice procedures § It’s as easy as “writing a prescription” § Therapy can be done anytime, post surgery 3/15/2018 12. 10. 2009 12. 10. 09 40 40 www. revitalvision. com
INCORPORATING IN PRACTICE § Cataract and LASIK products can be offered to patients § Minimum extra intervention by doctor’s office § Amblyopia: the only clinically proven treatment to improve vision for adult amblyopic patients § Other products: (amblyopia, presbyopia, low myopia, etc. ) Ø Bundle with surgery Ø Offer premium package Ø Include as part of standard of care (premium practices) Ø Offer to suitable candidates 3/15/2018 12. 10. 2009 12. 10. 09 41 41 www. revitalvision. com
INCORPORATING IN PRACTICE § Therapeutic opportunity for reduced contrast sensitivity as age and cataract surgery contribute to decline in CSF § Empowers the patient to improve their own visual outcomes § Additional tool for patient satisfaction § Make patient’s vision better § Empower patients to improve with their home “physical therapy for vision. ” § Minimum changes necessary at practice level § All technical needs are handled by Revital. Vision (distributors). § Patient progress monitored by Revital. Vison § Potential source for additional revenue for physician practices 3/15/2018 12. 10. 2009 12. 10. 09 42 42 www. revitalvision. com
INCORPORATING IN PRACTICE Offer Revital. Vision at Surgeon Office § Ø Ø Ø Bundle with cataract surgery Offer premium package – up charge Include as part of standard of care (premium practices) Referring Optometrist § Ø Offer Revital. Vision to patient at 3 or 6 month follow-up § All Post Surgical Patients § Patient undergo first guided training session at the clinic and the rest are done at home. Any technical issues are handled directly by Revital. Vision (local distributors) 3/15/2018 12. 10. 2009 12. 10. 09 43 43 www. revitalvision. com
SUMMARY § Novel approach to improvement in visual function Ø “Physical therapy for vision” Ø Computer based primary cortex vision training § Founded on proprietary cortical visual science therapeutic strategies § Average improvement of 2 lines visual acuity and 100% in contrast sensitivity § Non-invasive and safe § Multiple treatment indications offerings including amblyopia, post IOL implant therapy, post refractive surgery, presbyopia, Low Myopia, Low Vision, Sport Vision. § Future product offerings in development 3/15/2018 12. 10. 2009 12. 10. 09 44 44 www. revitalvision. com
CONTACT INFORMATION Revital. Vision, LLC www. revitalvision. com Neuro. Vision/Revital. Vision distributors: ISRAEL- Talshir Medical Technologies Ltd. Turkey- Noro. Vizyon Ltd. Greece – Vitamia Medical Ltd. 3/15/2018 12. 10. 2009 12. 10. 09 45 45 www. revitalvision. com
Скачать презентацию TECHNOLOGY CLINICAL SUMMARY 24 Feb 2010 Daniel
88b8ac3660e872ef4a5bddb5980e7f52.ppt