OHTS Baseline/Randomization Visit: BR

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Nickolas Harrington
5 years ago
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1 Page 1 of 5 2/28/5 OHBR02.00 Coordinating Center use only Rec d... Log d... Chk d... Entr d... Checklist Check when completed Before exam, patient first completes SF-36 Quality of Life Before exam, patient completes Symptom Checklist after SF-36 Quality of Life Record current medications (If patient forgot to bring in medications, complete this section by telephone.) Patient Tracking Form IOP Call Coordinating Center for randomization assignment Schedule next appointment for about same time of day a. Observation group. Follow-up Visit: (6 ± 1 month) Time: hh : mm am pm b. Medication group. IOP Confirmation Visit: (4 ± 2 weeks) Time: hh : mm am pm Dispense 1 mo. medication to patient randomized to medication Mail original Baseline/Randomization form to Coordinating Center within 1 week Coordinating Center Action List: Randomization Confirmation Form is faxed to Clinic Coordinator on day of randomization After receiving the Baseline Randomization form, the Coordinating Center sends clinic: Follow-up schedule for annual & semi-annual visits Randomization assignment stickers

2 Page 2 of 5 2/28/5 OHBR List below all medications taken by patient: 1 If patient did not bring in medications, coordinator should telephone patient to complete this section If patient is not taking medications, please check None 1 None (Skip to question #3) Consult PDR or OHTS Medication List in the MOP Ch. 12 to decide if any of the above are in the following categories: Check Yes or No for each category a. Systemic Beta-blocker... 1 Yes 2 No 26 b. Calcium Channel Blocker... 1 Yes 2 No 27 c. Anti-Depressant... 1 Yes 2 No 28 d. Ocular Corticosteroid... 1 Yes 2 No 2 e. Systemic Corticosteroid... 1 Yes 2 No Ask: Do any of the following blood relatives have glaucoma? a. Biological mother or father... 1 Yes 2 No Unknown 31 b. Biological brother or sister... 1 Yes 2 No Unknown 32 c. Biological aunt or uncle... 1 Yes 2 No Unknown 33 d. Biological grandmother or grandfather... 1Yes 2 No 3 Unknown Ask: Do you get migraine headaches?... 1 Yes 2 No Unknown 35 END01

3 Page 3 of 5 2/28/5 OHBR02.02 IOP is measured by two people -the OPERATOR aligns the mires -the RECORDER reads the dial 1 IOP Determination 5. Time of measurement. 1 am 2 pm OD OS st IOP nd IOP Are the 1st and 2nd IOP determinations less than or equal to 2 apart? Yes: Enter their average on line. No: Take a 3rd reading and enter on line rd IOP If a 3rd IOP is taken, enter the median (middle value) of 1st, 2nd, and 3rd IOP on line IOP Result Round to nearest whole number Round up when decimal is.5 or greater 42 Operator s Certification Recorder s Certification 46 This workbox is for clinic use only to help calculate goals for patients randomized to the medication group. The treatment goals are as follows: 1. An IOP 24 and 2. A 20% reduction in IOP from the average of the Qualifying IOP and the Baseline IOP result. The 20% reduction is not necessary if IOP 18. OD OS 1. Qualifying Assessment IOP average: (average of 1st and 2nd determinations done during QA). END02 2. Baseline/Randomization IOP result: 3. Final IOP result (average of #1 and #2): Round to nearest whole number Round up when decimal is.5 or greater

4 Page 4 of 5 2/28/5 OHBR02.03 After IOP is taken, call Coordinating Center for randomization assignment 1 Randomization Assignment 10. Certification of Central Coordinator giving randomization: Certification of Clinic Staff receiving randomization assignment: Central Coordinator gives randomization assignment as follows: 1 Medication 2 Close Observation 31 Start one-eyed trial Schedule return visit in 6 months Schedule IOP Confirmation visit in 4 ± 2 weeks 13. Check the eye selected for one-eyed trial: OD OS Check which eye drop medication is selected for one-eyed trial on page 5. END03

5 Page 5 of 5 6/1/5 OHBR02.04 Dispense sufficient medication for 1 month Ocular Medication Prescribed Dosage (# times daily) 18. Miotics OD OS 1 OHBR Pt. ID Dosage (# times daily) 14. Beta-Blockers OD OS Betoptic S 0.25% Pilocarpine 0.5%* Betoptic 0.50% Pilocarpine 1.0%* Pilocarpine 2.0%* Betagan 0.25% Pilocarpine 3.0%* Betagan 0.50% Pilocarpine 4.0%* Pilocarpine 5.0%* Timoptic 0.25% Pilocarpine 6.0%* Timoptic XE 0.25% Pilopine gel 4.0% Timoptic 0.50% Timoptic XE 0.50% *Check the brand name of pilocarpine used: Isopto Carpine 1 41 OptiPranolol 0.30% Pilagan 1 42 B&L Generic or Pilostat 1 43 Ocupress 1.0% Carbachol 0.75% Epinephrine/Dipivefrin Carbachol 1.50% Epifrin 0.5% Carbachol 2.25% Epifrin 1.0% Carbachol 3.0% Epifrin 2.0% Other Propine 0.1% Describe: 20. Systemic Carbonic Anhydrase Inhibitors (Open Arm only approval of Study 16. Alpha 2 Agonists Chairman required before prescribing) Iopidine 0.5% Diamox 125 mg Diamox 250 mg Topical Carbonic Anhydrase Inhibitor Diamox Sequels 500 mg Trusopt Neptazane 25 mg Neptazane 50 mg END If patient is randomized to medication, but no medication is prescribed for one or both eyes check here: None - OD 1 None - OS 1 5 and explain: ohbr0204.doc Investigator s Certification 61 END05

Visit Type (Check one)

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.