ISO 9394:2012 pdf download – Ophthalmic optics – Contact lenses and contact lens care products一 Determination of biocompatibility by ocular study with rabbit eyes
ISO 9394:2012 pdf download – Ophthalmic optics – Contact lenses and contact lens care products一 Determination of biocompatibility by ocular study with rabbit eyes.
9.1.3 Visually examine both eyes of each rabbit using the slit lamp (7.1) and fluorescein stain (6,1). and record the state of the eyes using the McDonald.Shadduck scoring system (see Annex A).
If either eye shows any abnormality, then replace the rabbit.
9.2 InsertIon and removal of test lens
92.1 Treat the test lens in accordance with 8,2.
9.2.2 Insert the test lens Ii one eye of the rabbit; the eye should be free from fluore5cein at the time of lens inseflion. The test lens may be inserted in either eye, although it is recommended that within a test laboratory all testing be carfled out on the same side. The contra-lateral eye serves as either a treated or an untreated control,
NOTE In the case of hydrogel lenses, the ho may be loosely taped neat the outer cwthus h prevent expulsion of the lens.
9.2.3 On days I to 21. after 7 h to 8 h, remove the test lens from the rabbit’s eye, After removal, lenses shall be cared for as described in 8.2.
NOTE Designate the first day of lens wear as day 1.
9.2.4 If, dunng the course of the days weanng, a lens requires reinsertion or replacement, this fact shall be recorded. It is recommended that the presence of the lens Wi the rabbit’s eye is checked regularly. e.g. hourly.
NOTE An appropriate contact lens rewetting solution can be used to hydrate the contact lens and aid m retention of the contact lens during tens wear. The use of such a solution shall be recorded.
9.2.5 When the contact lens rewetling solution is the test article, the solution shall be applied dunng lens wear as defined In the test protocol.
9.2.6 Whenever relevant, record any change in the appearance of the contact lens.
9.2.7 Repeat 9.2.1 to 9.2.6 on a daily basis.
92.8 On day 22, after 4 h to 8 It, remove the test lens from the rabbit’s eye. NOTE The lens may be retained for further examination by the manufacturer.
9.3 Examination of the rabbit’s eye
9.3.1 On days 1 to 7,9 to 14 and 16 to 21. just prior to lens removal, visually examine both eyes of each rabbit and record the state of the eyes using the Draize scoring system (see Annex B).
Additional visual examinations of the eyes may be conducted, e.g. twice daily, so that if a reaction is found, an early endpoint can be instituted. It is recommended to also record the behaviour of the rabbits, Scratching or pawing at the lens would be an early sign that it is irritant.
9.3.2 On days 8. 15 and 22 after lens removal, visually examine both eyes of each rabbit using the slit lamp (7.1) and fluorescein stain (6.1) and record the state of the eyes using the McDonald-Shadduck scoring system (see Annex A).
NOTE Specific days for interim slit lamp examinations may be changed to accommodate the scheduling ci the study activities, but Slit lamp examinations should be conducted at 7 days ± 1 day intervals.
9.4 WeIghing of animals
On day 22. using the balance (7.3). weigh the rabbits and record the mass.
9.5 Histological examination
9.5.1 On day 22, after the lens has been removed and the clinical examination has been completed, the
animal should be humanely klled.
9.5.2 Excise the eyes and adnexa and preserve in a suitable fixation solution (e.g.10 % neutral buffered
formalin, Zenker’s acetic fixative or Davidson’s solution).
9.5.3 Embed the eye and adnexa in paraffn wax.
9.5.4 Section the cornea, conjunctivae, inis and lens of each eye and stain for microscopic evaluation.
Evaluation of the rabbit’s eyes and examination of histological sections shall be conducted by appropriately
experienced and competent personnel.
9.5.5 Examine the histological sections and record the findings.
9.6 Corneal metabolism
If appropriate, determine efects on corneal metabolism using appropriate chemical or physical methods, taking
into account the current state of the art.
NOTE If corneal metabolism is to be evaluated, data from a minimum of three rabbits should be provided for each test and control group.
10 Assessment of results
10.1 The overall assessment of the test results shall be carried out by appopriately experienced and competent personnel, taking into consideration all information in the test report.
10.2 If the appopriately experienced and competent personnel considers the results to be either inconclusive or invalid, consideration shall be given to repeating the test.
10.3 The results of the asessment shall be recorded in the test report.
11 Test report
The study report shall include at least the fllowing information:
a) name and address of the testing fcilit;
b) name of the person(s) who conducted the test;
c) statement of compliance to appropriate good laboratory practices;
d) name and complete description of test/control artile(s);
e) description of test animal (species, source, age, sex, body weight and number of animals);
f) justifications and descriptions of test method.