EUGOGO FOLLOW-UP assessment

Transcription

1 EUGOGO FOLLOW-UP assessment Please complete non-italicized boxes except where indicated, plus relevant italicized ones. F1. Date follow-up (dd mm yyyy) Visit # Year of birth ( yyyy ) Randomization code F2. Recent thyroid status Dysthyroidism since last data sent None F3. Current thyroid status Hypothyroidism Hyperthyroidism 3.1 Current thyroid medication Time since starting (months) carbimazole mg day methimazole mgday PTU mgday T4 T3 No medication µgday µgday 3.2 Thyroid Tests ft4, pmoll, ngdl ft3, pmoll, pgml OR T3, nmoll TSH, mul TSH RAb, specify units and assay TPO Ab kul specify upper limit of normal F4. Laboratory tests Total white blood cell count (cellsnl) Neutrophils % Lymphocytes % Monocytes % Eosinophils % Basophils % CRF-FOLLOW-UP-GJK 1

2 AST ALT γgt ALP Ul Ul Ul Ul F5. Concurrent medications (please list all medications) Drug Dose Times per day F6. Physical examination Height (m), Body Weight (kg), Pulse rate (min) Blood pressure (mmhg) Is any adverse event occurred after the beginning of the study? No if yes, you must compile the AE form F7. Safety 7.1 Major side effects a. Development of diabetes mellitus requiring therapy No b. Development of major depression or psychosis No c. Severe infections requiring hospitalization No d. Any side effect neccessitating withdrawal No CRF-FOLLOW-UP-GJK 2

3 Please specify e. Increase of the safety laboratory values: 1. Creatinine > 2mgdl No 2. Liver enzymes: >5x upper limit of normal (ULN) No 3. Any toxicities: Grade 3 or 4 according to NCINIH CT Criteria No 7.2 Minor side effects a. Increase of body weight (increase of>4 in BMI) No b. Gastric symptoms not improving on omeprazole No c. Development or worsening of hypertension (diastolic >90 mmhg) No F8. Smoking Never smoked if you have ticked this box go straight to section F9 Ex-smoker when stopped (dd mm yyyy) Current smoker current daily intake Passive smoker F9. Graves orbitopathy: current status SYMPTOMS - during last four weeks 9.1. Painful oppressive feeling in or behind globe No 9.2. Gaze evoked pain No 9.3. Excessive watering No CRF-FOLLOW-UP-GJK 3

4 9.4. Photophobia No 9.5. Grittiness No 9.6. Double vision No 9.7. Gorman score (NB: if wearing prism daily then score as constant ): no diplopia intermittent inconstant (gaze evoked) constant in 1º or reading 9.8. Blurred vision No F10. Ophthalmic examination Right OD Left OS Best visual acuity (decimalised),, RAPD No No Normal Abnormal not tested Normal Abnormal not tested Colour vision SOFT TISSUE SIGNS (all according to atlas) Eyelid swelling (equivocal= no ) No Mild Moderate Severe No Mild Moderate Severe Eyelid erythema No No Conjunctival redness No Mild No Mild Chemosis (mild= no ) No No Caruncle OR plical swelling SHORT CAS ODOS No No 7 7 EYELID POSITIONS (examine with distance fixation) Palpebral aperture* mm mm ( *insert asterisk after measurement if it is not possible to measure PA in primary fixation) (+ - ) (+ - ) Upper lid retraction mm mm (relative to limbus) Lower lid retraction mm mm (relative to limbus) Lagophthalmos No No CRF-FOLLOW-UP-GJK 4

5 PROPTOSIS (mm) Intercanthal distance Exophthalmometer CORNEA no keratopathy ulcer no keratopathy ulcer LENS Clearcataract Clearcataract OPTIC NEUROPATHY ASSESSMENT (in addition to VA, colour + pupil assessments) Disc normal atrophic swollen normal atrophic swollen Choroidal folds No No Is there evidence of optic neuropathy? No Equivocal No Equivocal please specify any addition evidence for this e.g. visual fields, VEP, contrast sensitivity INTRAOCULAR PRESSURE In primary gaze In upgaze MOTILITY a) Abnormal head posture present b) Orthotropic No No If no, what is manifest deviation with preferred distance fixation and without head posture exotropia esotropia none none right right left left hypotropia hypertropia none right left none.. right left c) Binocular single vision possible without prism No d) Monocular ductions ( ) Right OD Left OS adduction abduction elevation depression CRF-FOLLOW-UP-GJK 5

6 F11. CONCLUSION A. Total CAS score SHORT CAS + 2mm proptosis increase; >8º ocular excursion decrease; acuity loss of 1 Snellen line Total CAS ODOS B. NOSPECS OD OS Please complete all numbered boxes with 0,a,b or c (0 = absent, a = minor, b = moderate, c = severe) For class 3 (proptosis): 0 = < 20, a = 20-22, b = 23-25, c = > or = 26 (in mm) For class 4 (diplopia): 0 = absent, a = intermittent, ab = inconstant, b = constant, c = fixed eyes C. TOTAL EYE SCORE The total Eye Score is calculated as the sum of each NOSPECS class present times the grade in that class (for that purpose 1,2 and 3, respectively, are substituted for grades a,b and c) ODOS F12. GO QUALITY OF LIFE questionnaire To be filled at 0, 12 and 24 weeks, seriously limited, a little limited No, not limited at all 1) Bicycling (never learned to ride a bike ) 2) Driving (no driver s license ) 3) Moving around the house 4) Walking outdoors 5) Reading 6) Watching TV 7) Hobby or pastime, i.e. CRF-FOLLOW-UP-GJK 6

7 8) During the past, week, did you feel hindered from something that you wanted to do because fo your thyroid eye disease?, very much so, a little No, not at all 9) Do you feel that your appearance has changed because of you thyroid eye disease? 10) Do you feel that you are stared at in the streets because of your thyroid eye disease? 11) Do you feel that people react unpleasantly because of your thyroid eye disease? 12) Do you feel that your thyroid eye disease has an influence on your self-confidence? 13) Do you feel socially isolated because of your thyroid eye disease? 14) Do you feel that your thyroid eye disease has an influence on making friends? 15) Do you feel that you appear less often on photos than before you had thyroid eye disease? 16) Do you try to mask changes in appearance caused by your thyroid eye disease? F13. Study medication Date of first application of the study medication (dd mm yyyy) I have reviewed and found all data pertaining to this subject to be complete and accurate: Date and Investigator s signature CRF-FOLLOW-UP-GJK 7