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   Table of Contents      
ARTICLES
Year : 1983  |  Volume : 31  |  Issue : 6  |  Page : 731-732

Radial keratotomy controversy in the U.S.: A closer look


West Virginia, USA

Correspondence Address:
V K Raju
West Virginia
USA
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Source of Support: None, Conflict of Interest: None


PMID: 6676254

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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

How to cite this URL:
Raju V K. Radial keratotomy controversy in the U.S.: A closer look. Indian J Ophthalmol [serial online] 1983 [cited 2019 Oct 18];31:731-2. Available from: http://www.ijo.in/text.asp?1983/31/6/731/29312

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.[2]. 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 Top


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.[6]

 
  References Top

1.
Sato T, Akiyama K Shibata H: A new surgical ap­praoch to myopia. Am J. Ophth 36:823, 1953.  Back to cited text no. 1
    
2.
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.  Back to cited text no. 2
    
3.
Yenaliev FS: Experience in surgical treatment of myopia.Vestn Ohtalmol 3:52, 1978.  Back to cited text no. 3
    
4.
Fyodorov SN, Durnev VV: Opoeration of dosaged dissection of corneal circular ligament in cases of myopia of mild degree. Ann Ophth 11:1885, 1979.  Back to cited text no. 4
    
5.
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  Back to cited text no. 5
    
6.
Gonzalez ER: Eight centers to assess radal keratotomy. JAMA 245:899, 1981.  Back to cited text no. 6
    




 

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