Refractive Surgery News

Rather than emphasizing the likely increased risks of performing LASIK in a patient with already compromised vision secondary to retinopathy of prematurity (ROP), the notes at the Nevyas Eye Center state that he is a "good candidate for LASIK".  Exclusion criteria C, 5 of the protocol lists the "Presence of any clinically significant abnormality on physical or ophthalmic examination that would contraindicate outpatient refractive surgery."  ROP would be a clinically significant abnormality.  I do not know of any surgeon who has performed LASIK on a patient with Mr. Morgan's degree of ROP.  He was simply not an appropriate candidate.

There are 3 problems with performing LASIK on eyes with ROP.  The first is that the retina is already compromised by the primary disease and the increased pressure in the eye (often 3 to 5 times normal) can by itself damage a normal retina and this risk would be increased in an already compromised retina where the macula has been stretched or dragged temporally.  Although exams by retinal specialists has failed to document obvious retinal damage, one cannot rale out hypoxic or pressure induced damage to the macular area during the cutting of the flap which would account for his decreased vision.

The second problem with a patient with ROP is that optic nerve and the nerve fiber layer of the retina are more susceptible to damage from the increased intraocular pressure from the application of the suction ring.  Dominic does have abnormal optic nerves, which appear to by hypoplastic in the photos from 4/6/98 at the Nevyas Eye Center and by my exam.  The report by Dr. DeJuan at Hopkins also describes "anomalous" optic discs.  These small hypoplastic optic nerves are more prone to damage during LASIK.

Cases of optic nerve damage have been reported following LASIK have been reported even in normal eyes.  The LASIK procedure can cause subclinical ischemic damage to the optic nerve or nerve fiber layer of the retina but not enough to result in obvious optic nerve atrophy or pupil defects.  The visual field testing (Goldman) performed at Wilmer shows paracentral scotomas in both eyes and the interpretation by Dr. Zack on 12/6/99 describes, "specific loss including a number of common disorders, most commonly glaucoma."  Clearly Dominic does not have glaucoma so these field defects point to damage from the increased intraocular pressure during LASIK in an abnormal optic nerve.  The GDX study from March 27, 2000 also shows abnormal nerve fiber layers in both eyes which would usually indicate glaucoma but here is simply an indication of his ROP. If feasible I recommend Patterned Visual Evoked Potential testing to evaluate his optic nerve function. 

The third problem with an ROP patient involves the controversy of whether to center the excimer ablation over the pupil, as recommended by Guyton Ellis and Hunter, or over the visual axis, as suggested by Wachler and Buzzard. Although this argument is often moot in most normal eyes, the dragged macula in ROP and the significant positive angle Kappa make this a more significant decision in an ROP patient.  Indeed, the inability of Nevyas to be certain where to properly center the excimer ablation in an ROP patient is another reason why LASIK was inappropriate. 

The topography following the LASIK appears to be well centered over the pupil.  Because Mr. Morgan visual axis or "line of sight" is not looking through the center of the pupil, this may be partially responsible for his visual aberrations and decreased vision.  It does not appear that this issue was ever discussed with Mr. Morgan as a potential problem with doing surgery on him as opposed to a truly "good candidate. The Nevyas note of 4/27/98 mentions the "patient was looking nasal to fixation target intraop" and that there was "temp decentration OS."  It is possible that Mr. Morgan's line of sight to his temporally pulled macula passes through a peripheral portion of his ablation rather than the central portion and that may explain some of his decreased vision and night symptoms of glare and ghost images.  Under these circumstances it may have been more appropriate to center his ablation over the line of sight rather than the pupillary center. 

This mismatch between the center of the ablation and the temporally displaced macula as a possible explanation for Mr. Morgan's difficulties is also mentioned in the letter from Dr. DeJuan and the letter from Dr. Paul Maurius Bear dated 7/21/99.
 

Mr. Morgan states and it is confirmed on his patient history dated 3/10/98 that he came to the Nevyas Eye Associates because he heard a radio commercial on station KYW.  I have reviewed the script of radio advertisements, the Nevyas web pages, and a promotional Videotape of a program that was shown on cable television and may have been distributed to patients.  I have been told that all of these materials were used during the FDA investigation of the Nevyas Laser.  None of these materials included the FDA required warning that the device is limited to investigational use only.  The ads also represent that the procedure is safe, and in fact the TV ad shows a simulated blurred 20/200 vision quickly dissolving into a sharp 20/20 vision.  There are numerous other representations that the procedure is safe and effective.  If patients were responding to these advertisements and then were entered into the FDA study, that would represent a serious deviation from the standard of care and one that I am sure the FDA would be interested in these practices. 

It would also appear that the poor results obtained by Mr. Morgan with the significant decrease in his best corrected spectacle visual acuity of more than 10 letters were not properly reported to the FDA and that more patients were recruited for the study than were authorized by the FDA.
 

Despite these problems, Dr. Nevyas impression was that he was "doing well" and recommended and performed LASIK surgery on the dominant right eye on 4/30/98.  The imbalance between the two eyes that the patient experienced should have been corrected with a contact lens or glasses in the right eye while the situation in the left eye was evaluated.  The left eye eventually regressed to about -1.25 so it may actually have been possible for him to continue simply wearing glasses and a contact lens may not have been necessary.  This is especially true since the patient had a previous history of strabismus surgery and he may not have had true stereopsis so the anisometropia may have been easily tolerated and surgery on the right eye could have been deferred indefinitely.
 

Within a reasonable degree of medical certainty, it is my opinion that LASIK caused all the problems discussed above and in my report to occur. LASIK surgery usually does not provide a patient with vision better than his or her best corrected vision with spectacles or contact lenses.  Although common, this surgery is not without risk, and the practice is not to perform surgery on patients who already have compromised vision secondary to severe eye conditions.  By avoiding patients whose vision is already compromised to this degree we leave the patient a "safety net" in case the procedure leaves them with less than desirable results.  Certainly Mr. Morgan's ROP places him within a category of patients who needed that net, and Dr. Nevyas-Wallace took that net away.