Visit Type (Check one)

Transcription

1 Page 1 of 14 OHFV21.01 MULE: Page 1 Visit Type (Check one) Visit prior to 078 month visit enter visit window 0 Semi-Annual: Annual: 078 mo. 090 mo. 102 mo. 114 mo. 126 mo. 138 mo. 150 mo. 162 mo. 084 mo. 096 mo. 108 mo. 120 mo. 132 mo. 144 mo. 156 mo. 168 mo. 1. If OHTS II consent form is completed at this visit, check here: Consent and complete a Transition Visit Status (TV) form and send with this FV 2. Was information on this form obtained from a non-ohts office? No Yes If yes, enter OHTS PI or CC initials completing this form:

2 Page 2 of 14 OHFV21.02 MULE: Non Ocular Meds 1. Is the patient currently taking any of the following categories of medication? (Consult PDR or OHTS Medication List in the MOP Ch. 11 if necessary) a. Systemic Beta-blocker... Yes No b. Calcium Channel Blocker... Yes No c. Statin... Yes No d. Anti-Depressant... Yes No e. Ocular Corticosteroid... Yes No f. Systemic Corticosteroid... Yes No g. Nasal Steroid... Yes No h. Bronchial Inhaled Steroid... Yes No i. Estrogen or Progesterone for hormone replacement therapy... Yes No Certification (CC or PI)

3 Page 3 of 14 OHFV21.03 Clinic Coordinator/Investigator Instructions: Ask for ocular and medical history since the date of patient s last regularly scheduled follow-up visit (FV). MULE: Ocular History Ocular History 1. Have you had eye surgery since (state last FV date)? Yes No (If yes, complete Adverse Event Form and repeat Pachymeter measurement and complete PY form) 2. If yes, check appropriate boxes: a. Penetrating keratoplasty... Yes Yes b. Retinal detachment repair... Yes Yes c. Retinal tear... Yes Yes d. Laser trabeculoplasty... Yes Yes e. Laser iridotomy... Yes Yes f. Combined cataract/filtering surgery... Yes Yes g. Filtering surgery... Yes Yes h. Cataract extraction... Yes Yes i. Photo refractive surgery (e.g. LASIK)... Yes Yes j. Lid surgery... Yes Yes k. Other (describe):... Yes Yes 3. Are you currently using eyedrops to lower the pressure in your eyes?... Yes No Certification (CC or PI)

4 Page 4 of 14 OHFV21.04 MULE: Medical History Medical History 1. Have you seen a doctor since (state last FV date)?... Yes No If yes, for what problem(s)? 2. Have any new health problems been diagnosed... Yes No since (state last FV date)? (If yes, complete Adverse Event Form) If yes, check appropriate boxes: a. High blood pressure (hypertension)... Yes b. Low blood pressure (hypotension)... Yes c. Diabetes, or sugar in the blood... Yes d. Asthma... Yes e. Chronic lung disease... Yes f. Stroke... Yes g. Cancer... Yes h. Heart disease... Yes i. Migraine headaches... Yes j. Depression or other mental health conditions... Yes k. Other conditions: Yes 3. Has a previously reported medical condition worsened... Yes No requiring a change in therapy since (state last FV date)? (If yes, complete Adverse Event Form) If yes, check appropriate boxes: a. High blood pressure (hypertension)... Yes b. Low blood pressure (hypotension)... Yes c. Diabetes, or sugar in the blood... Yes d. Asthma... Yes e. Chronic lung disease... Yes f. Stroke... Yes g. Cancer... Yes h. Heart disease... Yes i. Migraine headaches... Yes j. Depression or other mental health conditions... Yes k. Other conditions: Yes 4. Have you had an inpatient hospitalization since... Yes No (state last FV date)? (If yes, complete Adverse Event Form) If yes, describe

5 Page 5 of 14 OHFV21.05 MULE: Medical History Medical History (continued) 5. Have you had any surgery other than ocular surgery... Yes No since (state last FV date)? (If yes, complete Adverse Event Form) If yes, describe 6. Have you missed work or been unable to perform your usual activities because of illness or accident since (state last FV date)?... Yes No If yes, describe (May require an Adverse Event Form) 7. (Ask Male Participants about prostate cancer at annual visits) a. Have you ever been told that you have prostate cancer?... Yes No If yes, what year were you first told that you had prostate cancer? b. Have you ever received treatment for prostate cancer either medication, radiation, or surgery? a. Medication... Yes b. Radiation... Yes c. Surgery... Yes History reviewed by Investigator Certification

6 Page 6 of 14 OHFV21.06 MULE: Blood Pressure Blood Pressure 1. 1st Blood Pressure Measurement Systolic/Diastolic: SYS /DIA Pulse 2. Reason for not having Blood Pressure or Pulse Data (check all that apply): a. Monitor inoperative... Yes b. Cuff too small... Yes c. Blood pressure greater than 280 mmhg... Yes d. Pulse too low... Yes e. Pulse too high... Yes f. Movement... Yes g. Other conditions... Yes 3. 2nd Blood Pressure Measurement Systolic/Diastolic: SYS /DIA Pulse 4. Reason for not having Blood Pressure or Pulse Data (check all that apply): a. Monitor inoperative... Yes b. Cuff too small... Yes c. Blood pressure greater than 280 mmhg... Yes d. Pulse too low... Yes e. Pulse too high... Yes f. Movement... Yes g. Other conditions... Yes Blood Pressure taken by

7 Page 7 of 14 6 OHFV21.07 MULE: Refraction Refraction (at 78, 90, 102, 114, 126, 138, 150, 162 mos.) 1. Refraction 2. Refraction Plus Minus. Plus Minus. Plus Minus. x Plus Minus. x Refraction taken by MULE: Snellen V.A. Snellen Visual Acuity Or choose 1. Snellen visual acuity / CF HM LP NLP 2. Snellen visual acuity / CF HM LP NLP Snellen acuity taken by If Snellen visual acuity is worse than 20/200, ETDRS VA is not required in that eye.

8 Page 8 of 14 OHFV21.08 MULE: ETDRS ETDRS Best Corrected Visual Acuity (at 78, 90, 102, 114, 126, 138, 150, 162 mos.) ETDRS visual acuity - 1. Testing distance in meters (check box) 4.0m 3.2m 2.5m 2.0m 2. Total number correct: ETDRS visual acuity - 3. Testing distance in meters (check box) 4.0m 3.2m 2.5m 2.0m 4. Total number correct: ETDRS acuity taken by MULE: Pelli-Robson Pelli-Robson Contrast Sensitivity (at 78, 90, 102, 114, 126, 138, 150, 162 mos.) Pelli-Robson - 1. Score from worksheet: Pelli-Robson - 2. Score from worksheet: Pelli-Robson taken by

9 Page 9 of 14 OHFV21.09 IOP is measured by two people - the OPERATOR aligns the mires - the RECORDER reads the dial MULE: IOP Determination IOP Determination 1. Date IOP completed / / 2. Time of measurement : am pm 3. 1st IOP mm Hg mm Hg 4. 2nd IOP mm Hg mm Hg Are the 1st and 2nd IOP determinations less than or equal to 2 mm Hg apart? Yes: Enter their average on line 6. No: Take a 3rd reading and enter on line rd IOP mm Hg mm Hg If a 3rd IOP is taken, enter the median (middle value) of 1st, 2nd, and 3rd IOP on line IOP Result mm Hg mm Hg Round to nearest whole number Round up when decimal is.5 or greater 7. Patient s Study Goal mm Hg mm Hg 8. Check here if using a Non-Goldmann Tonometer... Operator Certification Recorder Certification 9. Is IOP goal met?... Yes No Yes No 10. If IOP goal is met, you have three options: a. No change in treatment regimen... b. Change treatment regimen due to symptoms... Complete Adverse Event Form c. Change treatment regimen for other reason(s)... describe: 11. If IOP goal is not met, you have six options: a. Instruct patient to use eye drops on schedule... Schedule return visit in 4 ± 2 weeks b. Change medication this visit... Schedule return visit in 4 ± 2 weeks c. Change medication due to symptoms... Schedule return visit in 4 ± 2 weeks Complete Adverse Event Form d. No change, already on maximum meds... e. No change, patient declines medications... f. Other action, describe:

10 MULE: Ocular Examination Summary of Ocular Examination Page 10 of 14 OHFV Date ocular exam completed / / 2. External examination: Normal Abnormal, describe: 3. Slit lamp examination: Normal Abnormal, describe: Normal Abnormal, describe: Normal Abnormal, describe: 4. Presence of pseudoexfoliation: (At annual dilated exam) No Yes No Yes 5. Gonioscopy: (Complete at 90, 114, 138, 162 month visits) Open angles Open angles Narrow angles (Angle slit Narrow angles (Angle slit or Grade 1 in more than or Grade 1 in more than 25% of the circumference) 25% of the circumference) Appositional (Angle closure Appositional (Angle closure over more than 25% of the over more than 25% of the circumference) circumference) Closure (PAS over more than Closure (PAS over more than 25% of the circumference) 25% of the circumference) 6. Direct ophthalmoscopic examination: Normal Abnormal (other than disc hemorrhage), describe: Normal Abnormal (other than disc hemorrhage), describe:

11 MULE: Ocular Examination Summary of Ocular Examination (continued) Page 11 of 14 OHFV If disc hemorrhage: (check here) Yes (list clock hours): Yes (list clock hours): : to : : to : 8. Investigator answers the following question: Has patient developed any condition(s) that can cause visual field loss (pituitary lesion, demyelinating disease, pseudotumor, etc.)?... Yes If yes, describe No Investigator Certification:

12 Track medications prescribed to patient (6 month supply) Enter quantity of zero if no medications dispensed at this visit MULE: Ocular Meds Ocular Medication Prescribed Ocular Medication Dispensed # of Bottle if NOT Dosage Bottles Size from OHTS (# times daily) supply 1. Beta-Blockers Dispensed (ml) optional Betagan 0.25% Betagan 0.50% Betimol 0.50% Betoptic S 0.25% Carteolol 1.0% Istalol 0.5% OptiPranolol 0.30% Timoptic 0.25% Timoptic XE 0.25% Timoptic 0.50% Timoptic XE 0.50% Timoptic PsF 0.25% Timoptic PsF 0.50% Page 12 of 14 OHFV Epinephrine/Dipivefrin Propine 0.1% 3. Alpha 2 Agonists Alphagan-P 0.1% Alphagan-P 0.15% Iopidine 0.5% 4. Topical Carbonic Anhydrase Inhibitor Azopt 1.0% Trusopt 2.0% 5. Prostaglandin Analogue Lumigan 0.03% Travatan 0.004% Travatan-Z 0.004% Xalatan 0.005% 6. Combination Therapy (Beta-Blocker/Topical Carbonic Anhydrase Inhibitor) Cosopt

13 Track medications prescribed to patient (6 month supply) Enter quantity of zero if no medications Ocular Medication Prescribed dispensed at this visit MULE: Ocular Meds Ocular Medication Dispensed Page 13 of 14 OHFV21.13 # of Bottle if NOT Dosage Bottles Size from OHTS (# times daily) 1. Miotics Dispensed (ml) supply optional Carbachol 1.50% Pilocarpine 1.0% Pilocarpine 2.0% Pilocarpine 4.0% Pilocarpine 6.0% Pilopine gel 4.0% 2. Other Ocular Hypotensive Describe: 3. If medication was not prescribed for one or both eyes check the following: Eye(s) Reason (Check all that apply) None One-Eyed Trial None Adverse Event (Complete AE Form) None OU Treatment Change approved IOP goal met without medication Patient declines medication (Check reasons): Side effects Inconvenient Unable to self-dispense eye drops Patient thinks medications are not necessary Patient feels he/she is already taking enough medications Personal philosophy Other, describe: POAG Endpoint Reached Other reason, describe: Investigator Certification

14 Page 14 of 14 OHFV21.14 MULE: V.F. Series Humphrey 30-2 Visual Field Series Use OHTS certified perimeter only Ship diskette and printout to VFRC ASAP If 1st field is unreliable, repeat the field in 1 hour or schedule a visit in 4 ± 2 weeks using the Unscheduled Visit: UN form 1. For which eye(s) were Visual Fields taken for OU Neither this patient? 2. If taken, enter dates / / / / 3. If one or more eyes not done, explain: MULE: Optic Disc Photo Stereo Optic Disc Photography (Required at ANNUAL visits) Send checklist and photos to RC within 1 week If photos are missed, send checklist to RC (Reminder: Take photos as soon as possible) 1. For which eye(s) were Optic Disc Photos taken for this patient? OU Neither 2. If taken, enter dates / / / / 3. If one or more eyes not done, explain: If patient signed OHTS II consent, complete a new Transition Visit Status (TV) form. Copyright Ocular Hypertension Treatment Study All rights reserved