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Orthokeratology Development in the People's Republic of China - A Lesson for All (Nov, 2004)

By Jackson Leung OD, Polymer Technology Regional Manager for Asia

In recent months, negative articles and studies have been circulated regarding the adverse effects of wearing lenses for overnight orthokeratology. The purpose of this article is to attempt to explain the chronology and circumstances around those events, and perhaps shed some light on the reasons why these events in China in 1996. Under the government regulations in effect at that time, foreign manufacturers could not open their own companies in China. They were required to have a local partner or distributor who acted as the main shareholder in the company.

Since outside ortho-k manufacturers could not run and control local companies, they used pharmaceutical distributors who already had established contacts with hospitals and doctors.

Due to the immense geographical size and population of China, distributors often used sub-distributors for ortho-k lens sales. This created a multi-tier distribution network whose first level was the foreign manufacturer. The second level was the importer or regional distributor in Hong Kong or Taiwan. The third level was the in-country (local) distributor; the fourth level was the sub-distributor; and the fifth level was the doctors and hospitals. Most local distributors and sub-distributors were profit-oriented businessmen whose focus was on making money. Some of their advertising proclaimed "No more spectacles or contact lenses needed within 3 days"; "Say good-bye to myopia forever"; "20/20 in 20 days"; or "OK lens is very OK." They were clever in their use of even the letters representing orthokeratology (O.K.) to rename the lens "OK lens." This made it easy to promote and allowed them to speak very positively for the safety and benefits of ortho-k. In early 2001, there were approximately 400,000 wearers, 50% of them children and 50% adults. Many of the adult ortho-k wearers wanted temporary myopia reduction in order to enter the military, universities, or industries that require good unaided visual acuity. In 2000, some orthokeratology complications began to be reported. These complications were mainly due to the following four factors:

1. Lack of GP fitting skills and experience by the local doctors

GP lenses are relatively new to China. Most doctors had never fitted GP lenses before they fitted their first ortho-k patient. They had limited or no skill in observing fluorescein under a GP lens. They were attracted to fit ortho-k lenses because they saw an opportunity to earn large profits quickly fitting these lenses.

2. Education and training for the doctors was limited

Since there were so many distribution levels, communication was nonexistent between the labs who manufactured ortho-k lenses and the doctors fitting them. Some local distributors sold lenses as their own brand, further obscuring their sources and eliminating the chance for fitter training and consultation. The only training provided to doctors was held during national conferences. But these sessions were seldom focused on education for solving ortho-k fitting problems. There was limited patient education from the doctor as well. In some places, doctors were fitting ortho-k lenses without a slit lamp or keratometer.

3. inflated advertising claims

 Advertising focused only on the benefits of ortho-k lenses, making people feel it was safe and simple. There was no discussion of who might not be good candidates for ortho-k treatment. For this reason, patients' expectations for good results ran high and little consideration was given to possible problems or adverse effects.

4. Regulatory issues

The Chinese government began to regulate GP and ortho-k lenses in April of 2000. Before that time, there were no government testing requirements for imported or locally manufactured GP or ortho-k lenses.

Many distributors imported low Dk ortho-k lenses because they were less expensive. Most patients would not have immediate problems using low Dk ortho-k lenses for daily wear. But when worn during overnight ortho-k treatment, there were many corneal problems after three months of wearing. The first local ortho-k lens lab that opened in late 1999 was forced to close in 2001 due to the many court cases against them. They were allegedly making ortho-k lenses frome low Dk materials.

The complications reported consisted mainly of corneal ulcers or other corneal infections in children.

Most of these were believed to be caused by night wear of low Dk ortho-k lenses along with poor patient compliance, poor after care and follow up. These problems could have been avoided with better fitter skills, better patient education, and government requirements for testing and minimum standards for ortho-k lens materials.

But as often happens, these measures were put into place only after it came to light that serious problems were already being reported.

China has a population growth program that limits each couple to one child. Parents will often spend beyond their means for the welfare and benefit of this single child. Many concerned parents who wanted to try to slow myopia in their child paid up to three months or more salary to purchase ortho-k treatment.

As word began to spread, parents became very angry that their children were unknowingly subjected to these dangers. Some of them sued hospitals and doctors. Some of them filed complaints with the China Consumer Council. Some went directly to CCTV, the national television station. CCTV is the number one TV channel in China, reaching approximately 300 million people. CCTV ran a 30-minute TV program on the topic "OKlens Hurts Chinese." Although the program was not entirely negative, the message the public got was that orthokeratology was dangerous. Many hospitals and clinics closed.

By early 2003, the number of ortho-k lens wearers dropped to around 50,000. During the same period, the China government began to focus on the current practice of ortho-k in China. A panel of ortho-k experts was convened to identify, discuss, and develop solutions for the current problems. From these discussions, new rules for orthokeratology treatment were established that included:

‧Limiting ortho-k fitting solely to doctors.
‧Requiring that hospitals or clinics be properly equipped with slit lamps and topographers.
‧Requiring that patients sign consent forms that fully explained the procedure and the risks, and provided information on the lenses, supplier/distributor, doctor/hospital in triplicate with one copy given to the patient.
‧Classification of conventional GP and ortho-k lenses as Class 3 medical devices that would require a testing and approval process.
‧Minimum Dk of not less than 90 (ISO/Fatt).
‧Requiring clinical study data to be submitted for product registration.
‧Requiring clearly written product and patient instruction brochures.

After the sharp drop-off in ortho-k lens fits in 2001, many of the local distributors and sub-distributors disappeared due to loss of profits and to escape responsibility. The remaining distributors changed their business structure to become more responsible to the changing conditions. Some opend their own labs or with US labs as partners to help propel the ortho-k lens business properly. This group believes orthokeratology has great potential in China, and they are trying their best to promote it in a professional manner.

Polymer Technology began to focus on the China market during 2000. The first thing we determined was that basic GP fitting skills were lacking in China.

With this in mind, Polymer Technology introduced the first of its educational seminar series in China with the Boston Seminar 2001.

Since that time, approximately 2,000 doctors have attended seminars and lectures on the fundamentals of conventional GP lens fitting, and 3,000 self-learning CD-ROM GP fitting programs (developed by IER in Australia) and 700 Chinese-language GP educational VCDs have been distributed. Over 12,000 Chinese Boston Updates (five issues) have been distributed.

Polymer Technology plans to corontinue to sponsor seminars in China that offer extensive hands-on training. The company has strong relationships with the optometry schools in China, and provides educational materials and offers student scholarships in contact lens related subjects. Manufacturing laboratory growth within China is progressing. The laboratory within China will be the major suppliers of GP lenses directly to doctors to eliminate the multi-tiered distributor network that was troublesome in the past.

Polymer Technology has been at the forefront to assist local labs with material registration, testing, and developing sound manufacturing processes. The majority of the manufacturing labs are currently using Boston EO for conventional GP lenses and Boston XO for their orthokeratology lenses. We are confident the fitting skills of China's doctors will continue to improve and we are putting resources behind that effort. More local labs will be opened and these labs will directly distribute quality GP lenses to doctors, along with all the required support, such as fitting consultation, critical to the future success and health of this industry segment. The future of GP/ortho-k lens business in China is showing a healthy growth trend. Our aim is to assist that process wherever we can.