Learn Connect Succeed. JCAHPO Regional Meetings 2016

Transcription

1 Learn Connect Succeed JCAHPO Regional Meetings 2016

2 Development of PEDIG William F. Astle, MD, FRCS(C) Alberta Children s Hospital University of Calgary Calgary, Alberta, Canada PEDIG is a network dedicated to conducting multicenter studies in strabismus, amblyopia, and other eye disorders that affect children. Formed in 1997, the network is funded by the National Eye Institute. There are currently over 80 participating sites with over 184 pediatric ophthalmologists and pediatric optometrists Studies Supported by the National Eye Institute PEDIG Clinical Sites PEDIG International Clinical Sites Halifax Calgary Montreal Kingston Coordinating Center Mexico City Primary Focus of PEDIG The primary focus of PEDIG involves studies that Can be conducted through simple protocols with limited data collection Can be implemented by both university-based and community-based pediatric eye care practitioners as part of their routine practice. Structure of PEDIG The network is open and continually solicits the participation of new sites and investigators An Executive Committee provides oversight and establishes policies for the overall network Disease-specific Steering Committees provide oversight for individual protocols Planning committees are formed to develop new protocols, and are chaired/co-chaired by active members of the investigator group. A single Data and Safety Monitoring Committee serves all PEDIG protocols 1

3 Quality Control On-going Protocol Reviews Web-based data entry Site Visits Limit # s of pts. Enrolled at any one site Amblyopia Treatment Studies ATS 1-18 Definitions of Amblyopia Strabismic heterotropia at distance or near or history of strabismus surgery anisometropia <1.00 D Anisometropic anisometropia >1.00 D or astigmatism difference of >1.50 D Combined strabismic plus anisometropia >1.00 D or astigmatism difference >1.50 D Rationale Amblyopia is the most common cause of visual impairment in children The available data on amblyopia treatment are largely retrospective and uncontrolled Amblyopia, is usually treated with occlusion (patching) of the sound eye, though data suggest that pharmacologic therapy (atropine) may also be effective Amblyopia Treatment Study ATS1 A Randomized Trial of Atropine Versus Patching for Treatment of Moderate Amblyopia in Children VS Study Design A randomized, controlled single-masked multi-center clinical trial 2 treatment groups Patching Atropine Primary outcome: Visual acuity at 6 months 2

4 Eligibility Age < 7 years Able to measure visual acuity with single surrounded HOTV optotypes Strabismic and/or anisometropic amblyopia No more than 2 months of amblyopia therapy in prior 2 years Amblyopic eye - 20/40 to 20/100 Sound eye - > 20/40 Inter-eye acuity difference - > 3 lines Patching Treatment Initial 6 hours per day up to all waking hours at investigator s discretion Atropine Treatment Initial 1 drop atropine 1% daily in sound eye Visit Schedule During the first 6 months: 5 weeks, 17 weeks, 26 weeks From 6 months to 2 years a minimum of a visit every 6 months Masked outcome exams at 6 months and 24 months Electronic Visual Acuity Tester 20/400 20/200 20/100 20/50 20/25 Cause of Amblyopia N=419 Strabismus 38% Anisometropia 37% Combined-mechanism 24% Prior Treatment 26% received previous treatment for amblyopia 3

5 Amblyopic Eye Acuity N=419 20/100 23% 20/80 23% 20/60 22% 20/50 21% 20/40 11% Inter-eye difference (mean) 4.4 lines 20/80 20/60-20/60 20/60-20/50 20/40 20/30 20/25 20/20 Amblyopic Eye Mean Acuity at Each Visit Patching 20/50 + Atropine 20/ /30 20/ /30-20/30 0 wks 5 wks 16 wks 6 mos Summary There was substantial improvement in amblyopic eye visual acuity with both treatments Improvement was more rapid in the patching group The difference in amblyopic eye acuity at six months was small (about a third of a line) Both treatments were well tolerated, and few patients changed treatment because of side-effects Conclusions Both patching and atropine are effective treatments for moderate amblyopia in children 3 to less than 7 years of age Patching produces more rapid improvement and possibly slightly better outcome Atropine has easier administration and lower cost The initial choice of treatment can be made by the eye care provider and parent Conclusions of Amblyopia Recurrence Study Amblyopia Treatment Studies ATS2C An Observational Study of Recurrence after Completion of Amblyopia Therapy ¼ of successfully amblyopic children experience a recurrence over 1 year of f/u Recurrence risk is similar for stopping patching and atropine Most recurrences occur within 3 months early follow-up is critical but long term follow-up is also important If 6 or more hours of patching stopped recurrence risk is lower if patching is reduced to 2 hours per day before cessation suggests weaning is beneficial 4

6 Conclusions An Evaluation of Treatment of Amblyopia in Children 7-<18 Years Old Amblyopic eye vision improves with optical correction alone in about ¼ of 7 to <18 year olds. In 7 to < 13 year olds, additional improvement is seen with patching/atropine regardless of whether amblyopia was previously treated. In 13 to <18 year olds, additional improvement may occur with patching if amblyopia was not previously treated, but may not occur if previously treated. Most amblyopic eyes have remaining visual deficit. Study Objectives Amblyopia Treatment Study ATS4 A Randomized Trial of Atropine Regimens for Treatment of Moderate Amblyopia in Children To compare daily versus weekend atropine (twodays) for moderate amblyopia (20/40 to 20/80) in children 3 to <7 years old Conclusions Weekend atropine appears to be as effective as daily atropine in treating moderate amblyopia in children 3 to < 7 years of age The magnitude of the visual acuity improvement was similar to that seen for 2- hour and 6-hour prescribed patching regimens for moderate amblyopia. Amblyopia Treatment Study 5 Phase 1 Treatment of Anisometropic Amblyopia in Children with Refractive Correction 5

7 Study Objectives To determine in previously untreated anisometropic amblyopic patients: the incidence of resolution of amblyopia with spectacle correction alone the time course of visual acuity improvement with spectacle correction alone Conclusions Refractive correction with spectacles alone improves visual acuity in many cases and results in resolution in at least 1/3 of 3-<7 year old children with previously untreated anisometropic amblyopia Mean improvement is about 3 logmar lines Most cases of resolution occur with moderate amblyopia POTENTIAL ADVANTAGES OF AMBLYOPIA TREATMENT WITH SPECTACLES ALONE Some children will not need occlusion If occlusion needed: Better visual acuity when start Possibly better compliance One new treatment at a time AMBLYOPIA TREATMENT STUDIES ATS 7 Bilateral Refractive Amblyopia Study 20/40 20/400 VA Glasses for one year Conclusion VA from baseline: Improved from 20/63 to 20/25 Improvement of 3.9 lines Glasses alone are a powerful intervention Amblyopia Treatment Studies ATS 10 & 11 A Randomized Trial of Full-time Bangerter Filters versus Part-time Daily Patching for the Treatment of Moderate Amblyopia in Children A Randomized Trial to Evaluate 8 Hours of Daily Patching Plus Daily Atropine for Residual Amblyopia in Children 3 to <8 Years Old 6

8 LASEK Laser Assisted Sub-Epithelial Keratectomy ( E-Lasik / thin flap Lasik ) LASEK Dr. M. Camellin Italy Excimer laser ablation under a hinge of corneal epithelium Good combination of PRK and LASIK Study: LASEK in Children Corneal Haze was only complication noted in our PRK patient group Technolas B & L EyeTracker LASEK Technique Set-Up Under Laser Airway management options: Laryngeal mask airway Nasopharyngeal airway Standard Anesthesia Technique Anisometropic Amblyopia All Children lasered Failed Traditional Methods of Therapy Vision was NOT Improving 7

9 Anisometropes: France L. Evidence-Based Guidelines for Amblyogenic Risk Factors American Orthoptic Journal, Volume 56, Number 1, January 2006, pp.7-14(8) Results - Anisometropes At 1 year follow-up, LASEK treated eye SE (x-axis), vs. fellow Eye SE (y-axis) Anisometropic Groups N of pts Age Pre-op Refractive difference 12 yr Post-op Refractive difference Myopia (>3.00D) 39 Mean 7.32yrs (10mos-17.7yrs) Hyperopia (>3.50) 16 Mean 10.18yrs (3-16yrs) All patients 55 Mean 8.48yrs (1 yr-16yrs) Mean 9.12D ( D) Mean 5.84D ( D) Mean 4.77D ( ) Mean 1.18D ( D) Mean 0.94D ( D) Mean 0.56D ( D) 54% are within 1D of fellow eye 68% are within 2D of fellow eye 80% are within 3D of fellow eye Hyperopic Aniso : Pre & Post Laser (5.5 Year Follow-Up) Myopic Aniso : Pre & Post Laser (8 Year Follow-Up) Myopic Anisos Long Term Stability Hyperopic Anisos Long Term Stability 8

10 Vision lines 5/11/2016 Hyperopic Anisometropes 2 mos Post LASEK Hyperopic Anisometropes 1 YearPost LASEK N = 18 N = 18 A c h i e v e d (D) A c h i e v e d (D) Targeted (D) Targeted (D) Myopic Anisometropes 8 Years Post LASEK 63.6% of eyes had Visual Improvement Post LASEK Patient / n Fusion Case M. S. 100% 80% 60% 40% 20% negative stereo gross stereo fine stereo Stereo fine stereo gross stereo negative stereo pre-lasek Patient N = 26 % post-lasek Patient N = 32 % yr old Boy Referred from Ophthalmologist in Saskatchewan Unable to wear glasses / CTL s Amblyopia not reversing Patching / A 1% unsuccessful Referred for consideration of LASEK 0% pre-op post-op 9

11 Case M. S. OD D OS plano VA: OD 20/500 OS 20/20 No Strabismus Case M. S. March 2010: OD sphere OS sphere Cornea clear NO Haze November 2009: LASEK OD D Target: D Post laser August 2011 OD 20/20 OS 20/20 Now weaning off patch over next 2 months Case #4: Congenital Corneal Scar - PK X 70 = 20/50 Uncorrected VA = 20/400 Post LASEK sphere!! High Anisometropia 6 Year Old Boy OD OS X 100 LASEK OS: X 100 Post Laser VA Uncorrected = 20/25!! Post LASEK OS X 95 High Anisometropia 1998: 2 yr old Boy OD X 100 OS Sphere BCVA = OD 20/20 OS 20/400 High Anisometropia April 2008 OD X /20 OS X 70 20/80 POST PTK / Mitomycin / 2 nd LASEK : Sphere OU PRK 10

12 Corneal Scar / 2 0 PK 2004 Age OD sphere OS X 180 VA OD 20/20 OS 20/60 March 2, 2011 Age 11 OD X /20 OS X /40 Titmus 8/9! June 2009 Age 7 VA OD sphere 20/200 OS sphere 20/20 6 mos of patching / 6 mos of A1% March 2011 Age 9 Intensive patching / A 1% post LASEK VA OD sphere 20/125 OS sphere 20/20 Clear cornea centrally / no haze Titmus 3/9 No response / intolerant to CTL Artisan IOL Van Der Pol & Worst (1997) 1 st to describe Artisan IOL for aphakia 38 pediatric eyes Successful even in young children Phakic IOL s in Children Chipont EM J Refract Surg 2001 J DeFaber Rotterdam 11

13 Artiflex piol - Foldable Albinism LASEK OCA Age 2 yrs OU X 90 Glasses NOT tolerated VA still not quantifiable LASEK OU X 90 (Target D) VA immediately improved to 20/200 (not measurable pre-laser) Albinism piol s All 3 cases: No complications No dislocations No subluxation Excellent refractory results (as high as sphere and 3.75 D astigmatic errors) Endothelial counts remained acceptable Normal physiological loss considered to be 0.6%/yr This study: endo cell loss varied from 0.33% to 1.75% Many Other piol Studies in Children All show good levels of safety and efficacy 12

14 Alcon Cachet Posterior Chamber Phakic IOL s in Children piol for Myopic Correction High Myopia / Astigmatism Safety in Children? More Trials needed Femtosecond Lasers Femtosecond Lasers ReLEx Technique Refractive Lenticule Extraction SMILE Small Incision Lenticule Extraction ReLEx / SMILE ReLEx / SMILE Myopia Up to D Astigmatism Up to 5.00 D Hyperopia Some early successful reports Resection of hyperopic shaped lenticule thicker in periphery and thinner in center 13

15 ReLEx / SMILE Advantages over LASIK / LASEK Minimal discomfort Virtually no flap Less chance of Glare / Halos Better corneal stability / less chance of ectasia Preservation of subbasal nerve density Faster nerve regeneration ReLEx Smile in Children? AAPOS April 2016 Vancouver BC Larry Tychsen et al ReLEx for Anisometropic Amblyopia in Children 25 Children D to D Excellent visual results No Complications Safe / Accurate PEDIG Amblyopia Treatment Study ATS 19 Excimer Last Surgery for Anisometropic Amblyopia Recruitment Spring 2016 PEDIG Age 3-10 yrs Traditional Amblyopia Treatment has failed after 6 months PRK 90 subjects 2 Study Arms Surgical Non-Surgical Laser range: D to D 3.00 D difference between eyes > 3 logmar lines difference in VA between eyes PEDIG STUDY CONCLUSIONS What Has Been Learned? Surpising Results! 14

16 Findings Regardless of whether amblyopia is anisometropic or strabismic or combined, amblyopia can improve, and even resolve in some cases, with spectacles alone. In moderate amblyopia, prescribing 6-hours of daily patching is no more effective than prescribing 2 hours / day In severe amblyopia, prescribing full-time patching is no more effective than prescribing 6 hours / day Prescribing near activities with 2-hour I day patching is no more effective than prescribing distance activities 2 hours of daily patching can be effective for severe amblyopia Findings Daily Atropine is as effective as part-time patching for moderate amblyopia Daily atropine is no more effective than weekend atropine (two drops a week for moderate amblyopia Prescribing a plano lens at the time of initiation of treatment with weekend atropine (in moderate amblyopia) is no more effective than weekend atropine alone Weekend atropine can be effective for severe amblyopia Fixation switch with atropine, or better near VA in amblyopia eye on atropine, are not necessary for amblyopic eye improvement Findings Many children 7 to <13 years old respond to amblyopia treatment, and even some teenagers 13 to <17 years, particularly if previously untreated Bangerter filters are almost as effective as 2 hour per day patching as initial treatment for moderate amblyopia Reasonable Approach to Amblyopia Therapy in 2016 Treat amblyopia with spectacles first. Consider waiting until there is no further improvement. (even as long as12-14 weeks) If improvement is incomplete with spectacles alone, start additional treatment for moderate amblyopia with either: 2 hours / day of patching twice weekly 1% atropine Bangerter filter Consider patching 2 hours I day or twice weekly 1% atropine even for severe amblyopia Reasonable Approach to Amblyopia Therapy in 2016 Increase or switch treatment if visual acuity plateaus (increasing atropine involves adding a plano lens, but watch carefully for reverse amblyopia) Offer treatment to older children, particularly 7- to 12-year olds and previously untreated 13- to 17-year olds Be prepared to stop it there is a further plateau, 50% children have 20 I 25 or better amblyopic eye visual acuity following treatment. Reasonable Approach to Amblyopia Therapy in 2016 If all else fails, consider: Laser Refractive Surgery piols etc OK to use treatments in combination! Once refraction stabilized and balanced Standard treatments may then work 15

17 Definition of Success 20/30 or 3 logmar lines of improvement Only 25% of A1% pt. reached 20/30 Only 35% of pts. Reached 20/25 NOT enough Keep Going AGREE!! Current Recommendations Occlusion Works. But, Compliance is the issue Compliance is poor..up to 50% not doing what is Rx d!! Patching only ½ of what is Rx d!! Compliance Why is Compliance so bad? Stressors of Therapy Lack of Previous Improvement Parental Misunderstanding Key Elements Educate Parents Diaries Make Patches More Attractive / Comfortable Success Factors < 3 yrs Better Outcome Less Treatment Time to Outcome Course of Therapy Most improvement occurs in 6 wks Continues up to 16 wks. 16

18 EndPoint 20/20 Equal Vision Stop Tx: 3 consecutive 3 month visits with no change 6 mos of compliant therapy with no change Parents Explain Dx & Tx at 1 st visit Urgency Efficacy Emphasize to parents their capability to succeed Devise sound therapy plan Remember Past Compliance Predicts Present Compliance!! Rx More as they are probably only doing ½! Have a good follow-up Plan Wean at the End-Point 17