You’re Holding Your Eye Drops Wrong – What Makes Ophthalmology Trials so Challenging? by ignacio handal
You’re Holding Your Eye Drops Wrong – What Makes Ophthalmology Trials so Challenging? by ignacio handal
Last week, one of our resident experts in ophthalmology, Ignacio Handal, gave a training for some of our current studies with a focus on which pitfalls to avoid specifically in ophthalmology trials. He dished out many fun facts and eye-opening insights. Compliance is difficult enough to achieve for any medication, and remembering to take eye drops on top of oral medications is an easily forgettable extra step. Only half of glaucoma patients are compliant with treatment regimens, and that proportion falls further as the number of other prescribed medications increases. Eye drops are also uncomfortable (who wants to hold their eye open while they pour in a foreign liquid?). They can also be annoying and troublesome to administer, if the method is to try to hold the bottle steady while dangling it over your eye, especially if tremors are involved. But something many people don’t know is that the bottles are designed to rest on the bridge of your nose! This way, hand-eye coordination is less of an issue, and you sure don’t want to miss. Some of these eye drop medications are upwards of $600 per tiny bottle. Because vision is the relevant outcome in many ophthalmology studies, study assessments largely rely on patient-reported, and quite subjective, data. An example is the Humphrey test to measure visual field. In this exam, patients focus or fixate their gaze on a central light and then report whether they can see lights flashing in their peripheral field of view. The basic version takes about 10-15 minutes per eye, with longer versions taking up to 30 minutes per eye. Needless to say, this is exhausting for patients. In Handal’s experience, some patients will give great effort, and some will not. The biggest problem lies in inconsistency of effort: if patients give 100% effort the first time, and then taper off over time, it will look like they are losing vision over time, which is very problematic for studies measuring vision loss. Fortunately, there is a way to monitor how “compliant” patients are with the exam: their fixation can be measured with a small camera that captures eye movement. This at least allows physicians to determine whether the data is reliable or not. For this, though, Handal recommends telling the patient to give consistent effort, even if it is not 100% every time, so that significant reductions in overall vision can be tracked. There can also be troubles with assessments that are done by the physician, according to Handal. “You have to have good vision just to be an ophthalmologist.” Doctors don’t have an amazing view of the back of the eye; it’s a pretty blurry picture. This can complicate assessments and reduce the reliability of trial data. Continue reading the full article at: https://cutt.ly/drJztZ
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You’re Holding Your Eye Drops Wrong – What Makes Ophthalmology Trials so Challenging? by ignacio handal
- 1. OPHTHALMIC ANATOMY & PATHOLOGY by Ignacio Handal MONITORS GET THE WILL’S EYE MANUAL FOR REFERENCE
- 3. GLAUCOMA MACULAR EDEMA- D.R. PERIPHERY OU= BOTH EYES OD = RIGHT EYE OS= LEFT EYE WRITTEN OD/OS OD WRITTEN ON LEFT SIDE AS FACING PT OS WRITTEN ON RIGHT SIDE AS FACING PATIENT Conmed log each eye independent separate entries?
- 5. ANTERIOR CHAMBER POSTERIOR CHAMBER VITREOUS GEL LIGTH FOCUSING EQUIPMENT=BENDS LIGHT=REFRACTION 1. CORNEA 2. LENS 3. MEDIUM MEDIUM= AQEOUS HUMOR AND VITREOUS REFRACTIVE INDEX AQEOUS HUMOR
- 8. MIGs (istent, idose) ? Trabeculectomy? SLT laser? RK/PK In/Ex ?
- 9. ANATOMY OF THE DRAINS
- 10. “THE FAUCET” “The Drain”
- 13. 0.3 C/D = NORMAL 0.4= MINOR CHANGE-PRE G 0.5= MONITOR GLAUCOMA ~0.65 VISION LOSS BECOMES APPARENT 0.8-0.9 CUPED OUT- GOING BLIND CUP TO DISC IS THE TRUE INDICATOR OF GLAUCOMA- IOP=PRESSURE IS A RED FLAG LACK OF SYMETRY OU IS A BIG SIGN OF Dx >.1
- 14. C/D IS A SUBJECTIVE ASSESMENT- MAKE SURE PI TAKES HIS TIME AT SCR / BASELINE TO GET THIS RIGHT DISC OCT HISTORICAL IMAGES ARE BEST USED AS A REFERENCE POINT TO AVOID MISTAKES BETWEEN INVESTIGATORS
- 23. FAUCET DRAIN DRAIN
- 26. NON COMPLIACE IS THE LARGEST ISSUE • FINANCIAL • FORGETFUL • BURDENSOME • PHYSICALLY UNABLE TO DO IT ALONE • FRUGAL USE OF DROPS NO PATIENT IS 100% COMPLIANT NO SITE IS 100% COMPLIANT MISSED DOSES ARE A REALITY IN CLINICAL PRACTICE
- 27. • METHODS TO IMPROVE COMPLIANCE • NIGHT STAND / TOOTHBRUSH METHOD • NOSE LANDING PAD METHOD • KEEP EYES CLOSED FOR 4 MINS AFTER DROPS • DO NOT PUT IN VISINE OR TEARS RIGHT AFTER • DO NOT RUB EYES
- 29. AUTOMATED PERIMETRY HUMPHREYS VISUAL FIELD TEST- CENTRAL 24-2 FULL THRESHOLD – SITA STANDARD STRATEGY DEVIATION NO MORE THAN 20DB- CENTRAL 10 DEGREES NO SCATOMA SUBJECTIVE TEST- MUST GIVE GOOD INSTRUCTIONS AND PT MUST GIVE CONSISTENT EFFORT OR DATA ERRORS
- 30. C/D 0.1-0.3 C/D 0.45-0.7 C/D 0.65-0.7 C/D 0.8-0.9 CUPED OUT
- 31. IOP APPLANATION FACTORS EFFECTING GOOD APPLANATION • OD FIRST ALWAYS • NON CONTACT- AIR PUFF, EYE CARE • CONTACT – TONO PEN (STOP MA’S SCREENERS FROM TOUCHING STUDY PTS THEY WILL TOUCH THE EYE • HOLDING YOUR BREATH RAISES IOP • CROSSING LEGS • OVER WEIGHT PT SITTING IN APPLANATOR • HIGH BP –FORGOTTEN BP RX • STEROIDS • NOT MORE THAN 5 PTS APART OU • 21-34 IN RANGE • TRY TO STAY 21-25 FOR STUDIES • STUDY TEMPORAL WINDOWS KEY!
- 32. HELPFUL HINTS FOR OPHTHALMOLOGY STUDIES • ALCOA • OD FIRST ALWAYS-WHICH EYE, WHO DID IT • CONMED LOGS OD AND OS ASSIGNED • BCVA, VF AND NON CONTACT EXAMS FIRST • AVOID MA’S OR SCREENERS TOUCHING PTS • HYPEREMIA MUST BE FIRST BEFORE ALL • USE MAC AND DISC OCT AS REFFERENCE POINTS • SUBJECTIVE EXAMS, IOP, C/D, BIOMICRO BE SURE TO HAVE SAME RATER MAKE • PI MUSTTAKE EXTRA TIME AT SCR TO AVOID AE FROM UN REPORTED HX
- 33. GONIO-SHAFFER GRADING 0-4 0=CLOSED 4=WIDE OPEN SUBJECTIVE TEST NEED SAME RATER FOR EACH PT – STUDY CAN NOT DO THIS TEST DILATED*
- 34. THE CORNEA THE MOST BEAUTIFUL THING WE CANT SEE ITS ALIVE !!! GETS OXYGEN DIRECTLY FORM SURFACE DOES NOT REPRODUCE = DAMAGE IS IREVERSIBLE
- 37. PACHYMETRY= TELLS US HOW THICK THE CORNEA (K) IS NON CONTACT EXAMS FIRST THEN IOP PACHYMETRY, GONIO, AND DILATED EXAM WILL ALTER IOP RESULTS PACHYMETRY MUST BE CALIBRATED OFTEN PACHYMETERY #S VARY DEPENDANT ON WHERE YOU MEASURE ON THE CORNEA >555 THICKNESS WILL ALTER IOP TAKE 3 MEASUREMENT WITHIN 5 STANDARD DEVIATIONS APART!
- 39. K PACHY # AFFECTS IOP VALUES TOO THIN ADD IOP POINTS TOO THICK SUBTRACT IOP POINTS
- 41. K = ABREVIATION FOR CORNEA = K DYSTROPHY FUCHS DYS= GUTTAE
- 46. DILATED EXAM
- 47. TYPICAL RETINAL DX TYPES AND DISTRIBUTIONS Most CS should be Exclusionary for studies
- 48. Congenital Genetic Dx of RETINA Most are rare- difficult to study Spark-Virus Vectors-Future of Gene Therapies- why the eye as a model?
- 49. http://www.goodhopeeyeclinic.org.uk/oct.html
- 50. ANTERIOR CHAMBER POSTERIOR CHAMBER VITREOUS GEL CATARACTS- TYPES & SURGERY DESCRIPTION MEDIUM= AQEOUS HUMOR AND VITREOUS REFRACTIVE INDEX AQEOUS HUMOR
- 51. NS + 1 UP TO NS +3