APPLICATION TO INCLUDE A PROCEDURE, PHARMACEUTICAL OR OTHER DATA COLLECTION INSTRUMENT IN THE UNIVERSITY REGISTER

Transcription

1 Revised 09/99 APPLICATION TO INCLUDE A PROCEDURE, PHARMACEUTICAL OR OTHER DATA COLLECTION INSTRUMENT IN THE UNIVERSITY REGISTER Copies of the questions and instructions can be viewed by moving your mouse pointer over the yellow shaded area immediately above the answer block. NB: (to turn yellow area on, click on Tools top of your screen; select Options; go into the View tab; click on Hidden Text right hand side, half way down screen; press OK. Yellow boxes should now appear on your form) Alternatively refer to the Instructions for completing the APPLICATION TO INCLUDE A PROCEDURE, PHARMACEUTICAL OR OTHER DATA COLLECTION INSTRUMENT IN THE UNIVERSITY REGISTER. Title of Procedure, Pharmaceutical or Other Data Collection Instrument USE OF TOPICAL OPHTHALMIC DRUGS CYCLOPENTOLATE, TROPICAMIDE, PHENYLEPHRINE AND BENOXINATE Sponsor Title (eg. Prof, Dr, Mr/s) First name Surname Associate Professor David Atchison School/Centre: Centre for Eye Research Contact Person: (If not the sponsor) Address for correspondence: Telephone: Facsimile: School of Optometry, Queensland University of Technology, Victoria Park Road, Kelvin Grove Q 4059 (b/h) (a/h) D.Atchison@QUT.EDU.AU

2 2 1. DESCRIPTION OF PROCEDURE, PHARMACEUTICAL OR OTHER DATA COLLECTION INSTRUMENT This procedure covers the use of some topical ophthalmic drugs (drops applied to the surface of the eye) in vision and eye research. The drugs to which this applies are: % and 1.0% Cyclopentolate % and 1% Tropicamide % Phenylephrine % Benoxinate These drugs are used in routine optometric and ophthalmological practice. The procedure is that one or more drops are applied to the eye, usually to one lower corner, while the subject tilts his/her head backwards and looks upwards. The examiner (or subject) then occludes the tear drainage passage in the lower lid in order to slow drainage of the drug from the eye. This is a standard procedure to increase the efficiency of the drug. The purposes of cyclopentolate are to dilate the pupil of the eye and to paralyse accommodation (the focussing mechanism of the eye). Both effects occur together. In many investigations, it is important to have large pupils e.g in order for an observer to get a big field of view when viewing the back of the eye with an ophthalmic instrument. Sometimes it is an advantage to have an eye in a fixed level of accommodation. The main effect noticed by subjects is increased discomfort outside due to glare. A second effect is difficulty reading because of the loss of accommodation. Pupils may stay dilated for up to 48 hours and accommodation may be paralysed for up to 8 hours, but this varies between people. The purposes of tropicamide are the same as those of cyclopentolate, but tropicamide usually gives a lesser effect and lasts a shorter time. Pupils may stay dilated for up to 8 hours and accommodation may be paralysed for up to 4-6 hours, but this varies between people. Phenylephrine is an alternative to tropicamide and cyclopentolate when pupil dilation is required with minimal loss of accommodation. It is also used to accentuate the effects of the other two drugs because its mechanism of action is different. The subject will notice increased discomfort to glare, but this is much less marked than for the other two drugs as the pupil can still constrict to some extent in bright light. Effects may last 4 to 6 hours. The main purpose of benoxinate is to anaesthetise the front surface of the eye. This may be used to decrease the blink and reflex tearing reflexes, or to allow instruments to touch the eye without discomfort to the subject. A second purpose of benoxinate is to allow other drugs to be more readily absorbed and have quicker and longer lasting effects. The subject may notice an unusual sensation at the front of the eye while the drug is taking effect. The drug s influence lasts up to 15 minutes.

3 3 2. POTENTIAL RISKS 2(a) What are the risks? All these drugs are used routinely in optometric practice. Cyclopentolate and tropicamide are very safe drugs for which recorded systemic side effects are extremely rare. However, they can lead to raised intraocular pressure in some individuals, and screening shall be done for this. Phenylephrine is very safe in the low concentrations recommended. There are some people for which it is best not to use phenylephrine (asthmatics and people using tricyclic antidepressants, MAO inhibitors, guanethidine, beta blockers, reserpine, methyldopa or anticholinergics), and we will screen for this. Benoxinate is very safe; however, it is possible to scratch the eye without feeling sore because of the anaesthetic effect 2(b) 2(c) Comparing the risks to day-to-day living The drugs are used regularly by optometrists and ophthalmologists in routine eye examinations. The conditions under which the drugs will be used in research is identical to that for which they are used clinically. Minimising the risk For cyclopentolate and tropicamide, routine clinical procedures shall be used prior to the commencement of all experiments to screen out individual at risk of raised intra ocular pressure after drug instillation: 1. Intra ocular pressure less than 21mmHg 2. No history of glaucoma in subject or blood relaives 3. No glaucomatous signs observed at the back of the eye 4. Open anterior chamber angles (van Herick ratios at least 0.3) 5. No history of allergic or psychotic reaction to the drugs. For phenylephrine, in addition to the above procedures, blood pressure will be checked before testing, and a number of questions will be asked to screen for possible side effects: 1. No history of hypertension, heart disease, diabetes, hyperthyroidism or asthma, or the use of medications known to be used in the treatment of these conditions. 2. No use of tricyclic antidepressants, MAO inhibitors, beta blockers, reserpine, guanethidine, methyldopa or anticholinergics, The only problems expected with the above drugs are transient stinging when they are instilled and subject inconvenience. Subjects shall be worned about the stinging. As the pupil will remain dilated following the experiment, subjects shall be advised to bring a pair of sunglasses with them to avoid glare. To reduce inconvenience, in the case of cyclopentolate, tropicamamide and phenylephrine, only one eye should be treated where possible. Subjects shall be advised of the duration of time expected before their pupil size returns to normal and accommodation returns to normal levels. Subjects shall be assisted in travel after the experiment as required, and advised not to drive or cycle. For benoxinate, subjects shall be advised not to rub their eyes for at least 45 minutes after drug instillation. See attached: 2 (c) Screening questions and tests for cyclopentolate, tropicamide and phenylephrine 2(d) Managing the risk factor if it occurs Before leaving, the subject will be advised to contact the supervising experimenter by phone, or if not possible, to consult a GP immediately if there are any symptoms of pain in the eye, red eye, an acute decrease in vision, or other symptoms. 2(e) Health and Safety risks No, except as described above

4 4 2(f) Biosafety issues Nil 2(g) Genetic manipulation Nil 3. SCREENING 3(a) Should subjects be screened? Yes, as described at 2 (c) and on procedures or consent form 3(b) Special issues relating to the participation of minors No 4. CONSENT See attached form 5. OTHER ETHICAL CONSIDERATIONS No 6. BACKGROUND / LITERATURE REVIEW Please attach to your completed form (your response to this question must be no longer than 6 pages).

5 5 7. DECLARATION BY SPONSOR (PLEASE SIGN WITH A BLACK PEN) Title of Project: USE OF TOPICAL OPHTHALMIC DRUGS CYCLOPENTOLATE, TROPICAMIDE, PHENYLEPHRINE AND BENOXINATE I have considered the ethical implications of the inclusion of this procedure / pharmaceutical / other data collection instrument in the University s Register and deem the measures taken to be appropriate and in accordance with the National Statement on Ethical Conduct in Research Involving Humans. I understand that, regardless of whether or not the proposed item is included in the University Register, non-exempt individual projects which propose using this procedure / pharmaceutical / other data collection instrument will still require ethical clearance. Associate Professor David A Atchison Qualifications: BScOptom MScOptom GradCertEd PhD FAAO 8. DECLARATION BY FACULTY RESEARCH ETHICS ADVISOR I have considered this application and the ethical implications of the proposed procedure / pharmaceutical / other data collection instrument. I believe it appropriate to include this item in the University Register. Faculty: 13. DECLARATION BY HEAD OF SCHOOL / CENTRE DIRECTOR*1 NOTE: When the head of school or centre director is also a listed applicant, the dean should sign below. I have considered this application and the ethical implications of the proposed procedure / pharmaceutical / other data collection instrument. I support the inclusion of this item in the University Register. Position: *1 Only University Research Centres and Key Centres directors may sign. COMMENTS ON ETHICAL/RESEARCH CONSIDERATIONS: