Protocol & RecommendationsMarino Formenti, O.D., FIAO!

EurOK

E u r o p e a n A c a d e m y o f O r t h o k e r a t o l o g y!

Steps in developing Evidence Based Orthokeratology Protocol

Orthokeratology as a strategy for myopia control! Develop summary of evidence!

clinical efficacy (potential benefits)! Potential harms!

Weigh benefits versus harms of the procedure! Develop findings and recommendation statements! Document all aspects of the process!

E u r o p e a n A c a d e m y o f O r t h o k e r a t o l o g y!

http://www.eurok.eu/content/references!

E u r o p e a n A c a d e m y o f O r t h o k e r a t o l o g y!

E u r o p e a n A c a d e m y o f O r t h o k e r a t o l o g y!

E u r o p e a n A c a d e m y o f O r t h o k e r a t o l o g y!

http://www.ncbi.nlm.nih.gov/pubmed/23892491

E u r o p e a n A c a d e m y o f O r t h o k e r a t o l o g y!

Review of Research EvidenceStrength of evidence rating!

LEVEL! EVIDENCE! QUALITY!

A! Strong research based evidence multiple relevanthigh quality studies

B! Moderate research based evidence One relevanthigh quality study

C! Limited research based evidence One adequate studysomewhat relevant

D! Panel opinion based on information not meeting criteria for A-C

E u r o p e a n A c a d e m y o f O r t h o k e r a t o l o g y!

Practice of OrthokeratologyPre-Requirements!

Fitting Practice!

Reception of Lenses!

Delivery of Lenses!

Follow/up procedures!

E u r o p e a n A c a d e m y o f O r t h o k e r a t o l o g y!

E u r o p e a n A c a d e m y o f O r t h o k e r a t o l o g y!

Essential requirements for the Practice of Orthokeratology

Education and C.E.!

Comprehensive knowledge of the underlying Science of the Orthokeratology Process

Attendance of a Ortho-K course is firmly recommended. Course would have to be given by a Professional Organization with Orthokeratology in its mission (IAO or continental Section) Industrial and/or commercial education only cannot be accepted

Clinical Update is a MUST

Danger of obsolete or outdated knowledge Continuing Education: Congresses, workshops, Journals

Inexperience is no defence in terms of negligence!

Minimum Clinical Instrumentation & Procedures!

Topographer Biomicroscopy/Slit lamp

Fluoroscopy

Mandatory for corneal shape evaluation and fitting diagnosis Mandatory for anterior segment inspection and diagnosis Mandatory for corneal integrity evaluation and diagnosis

E u r o p e a n A c a d e m y o f O r t h o k e r a t o l o g y!

Essential requirements for the Practice of Orthokeratology

Ortho-k Lenses Trial Lens Set!

Protocol & Recommendations!

CE marking is a must in Europe !

Orthokeratology lenses Highest DK. Low and Medium DK are NOT suitable for Ortho-K Minimal O2 permeability = DK 87

Trial lens vs Empirical fitting If practitioner chooses to: send the ocular data to the manufacturer design the lens using a software The first lens ordered for the patient will be a trial lens

Orthokeratology Protocol EurOK Member is strongly recommended to practice in accordance with EurOKs Protocol EurOK Protocol & Recommendations are visible on the Website by interested persons

Professional Insurance EurOKs Member is strongly recommended to have a professional insurance

E u r o p e a n A c a d e m y o f O r t h o k e r a t o l o g y!

Fitting Protocol!Case History!

Present status of visual function! Eye-vision symptoms! Ocular history! Medical history!

Pre-fitting Examination!

Unaided and corrected Visual Acuity! Refraction! Corneal Topography. Instrumental calibration in necessary! Biomicroscopy !

E u r o p e a n A c a d e m y o f O r t h o k e r a t o l o g y!

Fitting Protocol!Delivery Care!

Patient has to be given:! verbal and practical insertion and removal techniques! verbal, written and practical instructions on cleaning and disinfection procedures! hygiene instructions: !

antibacterial detergent before manipulating the lenses, ! no use of tap water in rinsing lenses or container, ! replacement of the container

! Discuss post-fitting follow-up protocol!

Discuss risks and normal versus abnormal symptoms!

E u r o p e a n A c a d e m y o f O r t h o k e r a t o l o g y!

Delivery Care!

Fitting Protocol!

Early am in the morning after the first night! One week! Two weeks! Four weeks! 3 Months! 6 Months! 9 months! 12 months! Every 6 months!

E u r o p e a n A c a d e m y o f O r t h o k e r a t o l o g y!

Fitting Protocol!Patient Education!

Discuss the pros and cons of the procedures with the patient!

Discussion includes the following:! Treatment time is dependent on an individual basis! Initial treatment may need spectacle wear during the day! Overnight wear increases risks compared to daily wear lenses! Perception of halos or flare around lights at night may be experienced! Treatment includes a number of scheduled and unscheduled visits:!

Scheduled follow-up should be respected to avoid delay of treatment or complications. ! Unscheduled visits are necessary if unexpected complications arise.!

Instructions provided by the practitioner must be followed! Poor compliance may be risky and lead to complications! After the treatment has been complete, a follow-up every 6 months is required

to ensure eye health! Severe complications may need to stop the treatment!

E u r o p e a n A c a d e m y o f O r t h o k e r a t o l o g y!

Follow-up Protocol!

E u r o p e a n A c a d e m y o f O r t h o k e r a t o l o g y!

Lens Care!

E u r o p e a n A c a d e m y o f O r t h o k e r a t o l o g y!

Informed Consent!