Notice of the Ministry of health on strengthening the management of orthokeratology in medical institutions
Orthokeratology lens (commonly known as OK lens) is a kind of medical device which can change the corneal shape to correct ametropia by directly contacting the eyeball. In recent years, adverse reactions have occurred in patients during the use of orthokeratology lens, and some even caused serious consequences. In order to ensure medical safety and protect the rights and interests of patients, the following requirements are put forward for the practice management of orthokeratology in medical institutions: Yang Xiao, laser myopia treatment center, Zhongshan Eye Center, Sun Yat sen University
1、 Basic conditions for fitting orthokeratology lens
（1） Medical institutions
1. Having "medical institution practice license";
2. Medical institutions of grade II or above;
3. Ophthalmology is one of the subjects registered in medical institutions;
4. There are reception room, examination room, optometry room and wearing room, and have good sanitary conditions.
(1) Having the qualification of medical practitioner;
(2) Have the title of ophthalmologist above intermediate level;
(3) Those who have participated in the relevant knowledge training organized by the provincial health administrative department or the professional academic group entrusted by the provincial health administrative department and passed the examination.
(1) Have intermediate or above technician title;
(2) Those who have participated in the relevant knowledge training organized by the provincial health administrative department or the professional academic group entrusted by the provincial health administrative department and passed the examination.
To meet the basic requirements of fitting, the technician must complete the work of fitting OK glasses with the cooperation of ophthalmologists.
It is equipped with corneal curvature meter, corneal topography meter (measuring range of diameter above 8mm), non-contact tonometer, corneal thickness meter, computerized refractometer, comprehensive refractometer, refractor test box, slit lamp microscope, far / near visual acuity chart, ophthalmoscope, fundus, fluorescein sodium test paper, focimeter, lens projector (no less than 7.5 times), lens radian tester, etc.
2、 Operation specification
（1） Before fitting, the fitting personnel must inform the patients of the performance of orthokeratology lens, possible adverse reactions and side effects, fitting procedures, etc., and obtain the signature and consent of the patients.
（2） According to the examination data, whether it is suitable to wear orthokeratology lens should include: corneal morphology, corneal thickness, ocular axis, intraocular pressure, eye position, near / far vision, diopter, tear test, corneal diameter, pupil diameter, fundus examination in addition to routine examination of ophthalmic slit lamp.
（3） Try on the lenses before wearing them for the first time, and observe and evaluate the fitting status.
（4） According to the examination data and evaluation results, the fixation parameters and wearing scheme were designed.
（5） Provide guidance for the use of orthokeratology lens for patients, and distribute the guidance content to each patient in the form of "instruction manual".
（6） The follow-up visit system should be established and strictly implemented. The follow-up time is within two days after wearing OK glasses, and one week, one month, two months and three months after wearing OK glasses.
3、 The health administrative departments at all levels shall, in accordance with the relevant provisions on setting or changing diagnosis and treatment subjects in the "Regulations on the management of medical institutions", conscientiously do a good job in the daily supervision of medical institutions in their respective areas to carry out this diagnosis and treatment activity according to the above requirements. The medical institutions that have carried out the diagnosis and treatment activities within their jurisdiction shall be sorted out and rectified according to the above requirements, and the relevant situations in the implementation process shall be reported to our department in a timely manner.