Digital imaging and Telemedicine in ROP - NEONATUS 2016neonatus.org/wp-content/uploads/2017/10/Telemedicine-and-ROP-website.pdf• Comparisons of digital imaging and telemedicine to

Digital imaging and Telemedicine in ROP

Prof Nicoline Schalij-Delfos, MD, PhD

Paediatric Ophthalmology

LEIDEN UNIVERSITY MEDICAL CENTRE

THE NETHERLANDS

Retinopathy of Prematurity

Data Monitoring Committee Novartis Rainbow studies

RAnibizumab compared with laser therapy for the treatment of INfants BOrn

prematurely With retinopathy of prematurity

Disclosure Statement

Neonatus 2017 Poznan

Outline

• Digital imaging (DI) and Telemedicine (TM)

• Current practice

• Advantages and pitfalls

• Opportunities

• Review literature on grading accuracy

• Training

• Systemised algorithms


ROP-screening: Why?

Visual disability is largely preventable

when treatment requiring ROP is

detected and treated

in time


Screening technique

• Gold standard screening

• (Binocular) Indirect Ophthalmoscopy ((B)IO) by trained ophthalmologists

• Reports

• Drawings

• Written (EPD)

• Okay for the majority of screening examinations

• Comparison of FU examinations subjective

• Personal interpretation

• Dependent on expertise

• Issue in case of transfer to another hospital / screener

• Transportation for expert opinion (babylance)


Screening with camera

• Widefield Digital imaging (WFDI)

• Objective information for disease detection

• Facilitates comparison with previous images and retrospective analysis

• Easy to ask expert opinion by secured mail, app etc: Telemedicine (TM)

• Timing of treatment more exact

• Less transport of often critically ill infants

• Mo

• Most used and evaluated: Retcam (Natus Medical)

MMC Veldhoven


Additional advantages DI

• Can be done by ophthalmologist, neonatologist, physician assistant, nurse

(practitioner), paramedic or other trained personnel

• Extension of diagnostic expertise to underserved areas

• Local scarcity (available or willing) of qualified ophthalmologists

• Remote location of some NICU’s or High Care Centers

• Valuable for:

• ROP education and training (screeners and residents)

• Communication with parents

• Medico legal issues

• Facilitates computer based analysis of plus disease, THE hallmark for

treatment


Early initiative

• Wide Field Digital Imaging (WFDI) based TM: Retcam® 120

• 5 hospitals in the South of Germany

• Coded transfer of data to reading center

• Evaluation by experienced paediatric ophthalmologists

• (S)TR-ROP: suspected treatment requiring ROP

• N=1222

• 6 years FU

• 3.5% TR-ROP

• Sensitivity 100%, PPV 82.4%

• All TR-ROP detected in time

Lorenz B et al. Wide-field digital imaging based telemedicine for screening for acute retinopathy of prematurity (ROP). Six-year results of a multicentre field study. Graefes Arch Clin

Exp Ophthalmol. 2009 Sep;247(9):1251-62


Pitfalls DI / TM

• Digital imaging

• RetCam expensive (US$95 000 / €120.000)

• Number of infants per hospital with severe ROP relatively small

• Lack of or marginal insurance coverage and reimbursement

• Cost effectiveness studies are scarce and are not universally applicable

• Telemedicine

• Limited internet access

• Secure server

• Timely review

• Training of imagers and graders

• Certification process and licensing

• Medicolegal issues: final responsibility


Technical Pitfalls

• Image quality may limit ability for accurate diagnosis

• Hazy vitreous in extremely immature babies

• Temporary morphological changes

• Plus disease masked by camera compression on the eye

• Retinal hemorrhages

• Influenced by experience of imager


Alternatives for Retcam

• Panocam LT / Pro (Visunex Medical Systems, Fremont CA)

• Optomap (Optos PLC, Scotland, UK)

• Spectralis (Heidelberg, Germany)

• 3nethra (Forus Health PVT, Bangalore, India)

• I-phone with 20D (D-EYE)

• Indirect ophthalmoscopic digital photographic system (Keeler)

• …….

Issues:

• Portable and accessible for NICU population

• Review system

• Field of view (30 - 130°)

• Image quality

• Validation

• Pricing EH Wood et al. Evaluation of Visunex Medical’s PanoCamTM LT and PanoCamTM Pro widefield imaging systems for the screening of ROP in newborn infants, Expert Review of Medical

Devices (2016), 13:8, 705-712, DOI: 10.1080/17434440.2016.1208560

TS Oluleye. Mobile phones for retinopathy of prematurity screening in Lagos, Nigeria, sub-Saharan Africa. Eur J Ophthalmol 2016; 26 (1): 92-94


Review of literature

Sensitivity and specificity of grading

Pubmed and Cochrane search

• 486 papers

• 11 suitable for review

• 8 level 1 evidence (independant masked comparison)

• Sensitivity and specificity are high but differ dependant on

• Study design

• Population

• Time of screening / imaging

• Item graded (plus or type 1 or Zone or ROP stage)

WM Fierson et al. Telemedicine for Evaluation of Retinopathy of Prematurity. AAP Joint technical report. 10.1542/peds.2014-0978


Grading programs

• e-ROP: evaluation of acute phase retinopathy

• SUNDROP: Stanford University Network for Diagnosis of

Retinopathy of Prematurity

• KIDROP: Karnataka Internet-assisted Diagnosis for ROP


e-ROP

Evaluation of TM grading for detection of Treatment Requiring (TR)- or Referral

Warranted (RW)-ROP

• Trained nonphysician readers were compared to physicians

• good intragrader and intergrader consistency for detection of TR-ROP

• The likelihood of detecting RW-ROP by telemedicine screening is decreased

when a full set of retinal images (5) is not obtained

D Morrison et al. Impact of number and quality of retinal images in a telemedicine screening program for ROP: results from the e-ROP study. JAAPOS 2016

GE Quinn et al . Analysis of Discrepancy Between Diagnostic Clinical Examination Findings and Corresponding Evaluation of Digital Images in the Telemedicine Approaches to Evaluating

Acute-Phase Retinopathy of Prematurity Study. JAMA Ophthalmol 2016; Vol 134:1263-1270.


SUNDROP - KIDROP

• Stanford University Network for Diagnosis of Retinopathy of Prematurity

(SUNDROP)

• 6 yrs follow up

• Remote evaluation by ROP specialist

• Sensitivity 100%, specificity 99.8%

• KID-ROP – India

• Middle income countries: increased survival, scarce ROP experts

• Trained non-physicians

• Sensitivity 95.7%, specificity 93.2%

SK.Wang. SUNDROP: sixyearsofscreeningforretinopathyof prematurity withtelemedicine. Can J Ophthalmol 2015 (Vol 50:101-106)

A Vinekar et al. Need for Telemedicine in Retinopathy of Prematurity in Middle-Income Countries: e-ROP vs KIDROP. JAMA Ophthalmology 2015;133(3)


Conclusion

Grading DI – TM

good sensitivity and specificity

Vital issues are:

Training

Image quality

Responsibilities


Training

• No official certification or license for grading of images yet

• GEN-ROP (Global Education Network)

• A secure web-based tele-education system for ROP education

• 2,500 unique image sets of ROP

• Evaluation accuracy and liability of grading results during pretest, posttest, and

training chapters of 55 USA and Canadian residents

• GEN-ROP proved effective in improving diagnostic accuracy of ROP

• Tool for future certification

RV Paul Chan et al. The Global Education Network for Retinopathy of Prematurity (GEN-ROP): development, implementation and evaluation of a novel tele-

education system.Trans Am Ophthalmol Soc 2015;113:T2[1-26].


Timely feedback

Decisions about referral / treatment are needed in short time

• Referral for examination and consideration of treatment within 24 hrs

• Turnaround time (time from imaging to answer by reading centre)

• 95.5% within 24 hrs

• Delay

• Time acquisition - uploading

• Time incoming images and capacity reading centre to grade

GE Quinn. Timely implementation of a retinopathy of prematurity telemedicine system. JAAPOS 2016;20:425-430.


Image review Netherlands

• Secured app (Siilo): password, end-2-end data encryption, images are not

automatically stored and are deleted after 3 months

Work in progress:• Secured ophthalmologist network ‘Oogartsennet’

• Screening ophthalmologist upload

• Digital images

• Standard background information (GA, BW, AV, SatO2 levels etc)

• Questions

• Expert team (5) for review

• E-mail alert

• At least 2 reviewers have to respond

• Screening physician

• E-mail alert

• Takes final decision


Algorithms to detect plus disease

• Plus disease is main criterion for treatment (ET-ROP)

• Exact measurement of retinal vessel diameter

• provides objective information about changes in vessel width

• can be a predictor of disease progression

• Algorithms for identification (‘segmentation’) of retinal vessels

• Assisting / replacing (?) graders


Pre-plus PlusNo plus

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2760626/figure/F1/



Image analysis systems

• ROP tool

• Computer program to assess tortuosity (USA)

• Retcam-based

• ROP-tool and lay screeners good accuracy compared to 3 expert graders

• Oximetry (ODR and vessel width)

AM Abbey et al. Evaluation of Screening for Retinopathy of Prematurity by ROPtool or a Lay Reader. Ophthalmology 2016;123:385-390


Retinal oximetry (ROPOXYMAP-study)

• Fundus images using dual wavelengths

• Difference in light absorbance of hemoglobin bound and unbound to oxygen

• 633 nm sensitive to changes of oxygen

• 532 nm insensitive to changes of oxygen

• Oxymap software processing

• Relative oxygen saturation in the retinal vessel

• Vessel width

• Non contact, handheld camera


TM and DI

Telemedicine and digital imaging increase accessibility to

adequate care for a large population of infants

susceptible for ROP

High accuracy for detection of clinically significant ROP

improves healthcare for premature infants

Weaver DT. Telemedicine for retnopathy of prematurity. Curr Opin Ophthalmol. 2013 Sep;24(5):425-31. doi: 10.1097/ICU.0b013e3283645b41.


https://mail.lumc.nl/f5-w-68747470733a2f2f6d61696c2e6c756d632e6e6c$$/owa/redir.aspx?REF=C97vdi44W8XLgAu3WhZEDSaWRb9xAE7egPNq5lGyfGF15o60nOzTCAFodHRwOi8vd3d3Lm5jYmkubmxtLm5paC5nb3YvcHVibWVkLz90ZXJtPVdlYXZlciUyMERUJTVCQXV0aG9yJTVEJmNhdXRob3I9dHJ1ZSZjYXV0aG9yX3VpZD0yMzg3MjgxOQ..

THM

• ROP significant threat to vision

• Timely detection and appropriate timing of treatment is essential for

successful outcome

• Comparisons of digital imaging and telemedicine to the gold standard of

binocular indirect ophthalmoscopy are favorable

• Some evidence that digital imaging may even be superior in some aspects

• Practical and risk management considerations essential when including

DI-TM in any new or existing ROP care structure


Questions and discussion


Digital imaging and Telemedicine in ROP - NEONATUS 2016neonatus.org/wp-content/uploads/2017/10/Telemedicine-and-ROP-website.pdf• Comparisons of digital imaging and telemedicine to

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