|Year : 1983 | Volume
| Issue : 6 | Page : 731-732
Radial keratotomy controversy in the U.S.: A closer look
West Virginia, USA
V K Raju
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Raju V K. Radial keratotomy controversy in the U.S.: A closer look. Indian J Ophthalmol 1983;31:731-2
Perhpas the most controversial subject today in American Ophthalmology, indeed probably in all of American medicine, is the new surgical procedure known as radial keratotomy. This procedure is only the latest in a long line aimedat managing abnormal corneal curvature, thus correcting myopia, and eliminating the need for eyeglasses or contact lenses.
The radialkeratotomy, as we know it, was developed initially by Dr.Sato of Japan' who claimed 95% success in his series. Unfortunately follow-up studiesby Kanai revealed many of Sato's cases developed corneal edema after 20 years.. It was later learned that Sato's incisions damaged the endothelium, thus inducing edema.
Sato's technique was refined in the 1970's by Yenaliev, Fyodorov, and Durnev.3.4 These men employed a technique making equally spaced radial incisions from the anterior surface deep into the corneal, leaving a central 35 mm clear central zone. They reported excellent results.
This operation was introduced in the United States in 1978 by Bores who had observed it in Russia.5 But it was greeted with a degree of controversy when academic ophthalmologists felt it should be considered as an experimental procedure subject to normal rigorous testing.
The normal sequence of innovation, evaluation, and acceptance is standard procedure in American medical practice. The U.S. Food and Drug Administration has been castigated many times for taking too long to evaluate ostensible life saving drugs. But the tragedies with drugs like thalidomide, practalol, etc. are well known.
Academic ophthalmologists feel that sufficient evidence does not exist to justify surgical invastion of an otherwise healthy cornea. They do not think that the anticipated benefits out weigh the risks. This group convinced the National Institute of Health to label radial keratotomy as experimental, and to conduct a lengthy controlled study, consistent with acceptable medical research, before any consideration was given to its acceptance.
The group favoring immediate acceptance of radial keratotomy, consisting mostly of practicing ophthalmologists, is challenging the U.S.Government's right to interfere in the practice of medicine, and questioning both the mandate and capability of those charged with the responsibility of carrying out these testrs.
We are now in the midst of the evaluation stage which is characterized by a spirit of scientific caution and a demand of objective testing that yields carefully analyzed results. The goal is to determine the predictability, effectiveness, stability, and safety of this procedure - a necessarily slow, meticulous, and expensive process.
One planned evaluation study is a PERK (prospective evaluation of radial keratotomy) project, sponsored by the National Eye Institute.6 This study entails the services of 8 participating centers, performing approximately 500 procedures on patients. Each patient will be followed up for an extended period of time. Specular microscopy will be done and all patients subjected to glare testing. Each also will be carefully examined by investigators not involved with the original study.
| The future|| |
Radial keratotomy is a controversial political issue. Recently, two ophthalmologists and a group of patients filed a class action law suit against members of the Board of Directors of the American Academy of Ophthalmology, the National Advisory Eye Council, the National Eye Institute, and members of the PERK study claiming these groups are guilty of restraint of trade with regard to the practice of radialkeratotomy and of interference with contractual relationships between physicians performing the procedure and patients wish to receive it.
On the other hand, the academic ophthalmologists hold that radial keratotomy is investigational noting that almost any incidence of complications is unacceptable for an invasive operation on an eye with corrected visual acuity of 20/20 (6/6).
It is almost impossible to predict the future of radial keratotomy. In the next decade, this procedure will face one of two alternatives: the complications will be significant and the procedure discontinued; or the complications will prove minor and radial keratotomy will find its place in refractive surgery. Certainly technological advances will result in procedural refinment. BNut learning about the variables that determine its outcome will enable all of us to offer it precisely to those for whom it has the most chance of success.
| References|| |
Sato T, Akiyama K Shibata H: A new surgical appraoch to myopia. Am J. Ophth 36:823, 1953.
KanaiA. Yamaguchi T, Yajima Y,Funahashi M,Nakajima A: The fine structure of bullous keratopathy after anteroposterior incision of the cornea for myopia. Folia Ophthalmol Jpn 30:841, 1979.
Yenaliev FS: Experience in surgical treatment of myopia.Vestn Ohtalmol 3:52, 1978.
Fyodorov SN, Durnev VV: Opoeration of dosaged dissection of corneal circular ligament in cases of myopia of mild degree. Ann Ophth 11:1885, 1979.
Bores L: Purpose, protocol and goals of the national Radial Keratotomy study group, in Schachar RA, Levy NS and Schacher L (eds): Radial Keratotomy: Proceedings of the Society, Denison, LAL Publishing 1980, p 21
Gonzalez ER: Eight centers to assess radal keratotomy. JAMA 245:899, 1981.