March 01, 2003

Keith Wills v. Nevyas Eye Associates - Report on Standard of Care Deviation

Cornea Consultants
CORNEA & REFRACTIVE SURGERY

Kenneth R. Kenyon, MD, PC
Peter A Rapoza, MD, PC
Jonathan H. Talamo, MD, PC
David Miller, MD, PC
Kimberly C. Sippel, MD
Janet S. Rand, OD
Laser Vision Correction
Cornea and External Disease
Cataract and Implant Complications
Specialty Contact Lenses

31 January 2003

Frederic S. Eisenberg, Esquire
Litvin, Blumberg, Matusow & Young
Philadelphia, PA

RE:    Keith Wills

Dear Mr. Eisenberg:

In addition to examining your client, Mr. Keith Wills, I have also reviewed the records and depositions you provided concerning his eye evaluation and treatment.

The clinical history is summarized as follows:  In June 1997, Mr. Wills first came under the care of Dr. Herbert Nevyas for refractive surgery evaluation.  During this initial examination on 26 June 1997, Dr. Nevyas noted that Mr. Wills had last worn his soft contact lenses three days previously.  On examination, uncorrected visual acuity in the both eyes was counts fingers at four feet.  Subjective refraction was -10.75 -0.75 x 53 degrees improving vision to 20/20 minus 3 in the right eye and 13.0 -0.50 x 135 degrees improving vision to 20/20 minus in the left eye.  Pupil diameters were 5 mm under normal lighting and 6.25 under dim light conditions. The remainder of the anterior segment, intraocular pressure, ophthalmoscopy and topography examinations were normal.  Dr. Nevyas told Mr. Wills that he was an excellent candidate for laser vision corrective surgery and recommended LASIK procedures for both eyes.  Dr. Nevyas further requested that Mr. Wills obtain a peripheral retina examination by a retina specialist. Notably neither cyclopegic refraction nor corneal thickness measurements (pachymetry) were performed at this or any subsequent examination.

Dr. Nevyas next saw Mr. Wills more than 3 months later, on 7 October 1997, the date of his first LASIK procedure on the left eye.  The operative report form indicated that Mr. Wills' preoperative diagnosis was "High myopia", and the ablation zone of the excimer laser was 5 mm in diameter.  Two days later, on 9 October 1997, Dr. Nevyas performed a LASIK procedure on Mr. Wills' right eye.  Again, the preoperative diagnosis was "high myopia", and the laser again used performed a 5 mm diameter ablation.

Following surgery.  Mr. Wills developed difficulty with both distance and near vision.  He repeatedly complained to Dr. Nevyas that he had double vision, pain, glare, fluctuation of vision, halos, and starburst phenomena.  Dr. Nevyas assured him that these problems would improve over time.  After these initial LASIK surgical procedures, Dr. Nevyas performed multiple surgical enhancement interventions, but nevertheless, to date, Mr. Wills continues to suffer from significant visual glare, halo and starburst with multiple ghost images.

Eye examination performed by me on 21 January 2003, revealed uncorrected visual acuity of 20/30- in the right eye and 20/30+ in the left eye, albeit with subjectively significant multiple imaging.  With manifest refraction right eye: +0.50 -2.25 x 10 gave 20/40 vs. left eye: -1.0 -1.25 x 125 gave 20/40.  With gas permeable contact lenses and spectacle over refraction, 20/30 was obtained with each eye.  Keratometry was right eye:  36.0 x 150 / 36.0 x 70 and left eye: 37.0 x 55 /36.5 x 135 without distortion.  Externally both eyes were uninflamed.  Neuromuscular exam revealed pupillary diameters under dim light conditions of 6 mm both eyes (Colvard pupilometer).  By slit lamp, the corneas were clear with LASIK flaps in good position.  The tear film was stable and without irregularity despite the presence of minor microstriae centrally.  There were no significant interface debris or epithelial implantation.  The remainder of the anterior segment was normal, as were intraocular pressures, Schirmer tear testing and dilated ophthalmoscopy.  Ultrasonic pachymetry was 405 microns right eye vs 430 microns left eye.  Eye-Sys corneal topography displayed reasonably well centered ablations with minor surface irregularities bilaterally.  Orbscan topography was confirmatory and did not disclose significant posterior ectasia.  Finally, with Mr. Wills' own soft contact lenses inserted, the fit and centration were adequate and could not be improved in the opinion of our contact lens specialist, Dr. Rand.

In summary, based on my review of the medial records, depositions, ophthalmic examination and discussion with Mr. Wills, it is my opinion with a reasonable degree of medical certainty that Dr. Nevyas breached the applicable standard of care by operating on this highly myopic patient with an excimer laser utilizing a treatment zone that was substantially smaller than the pupil size in dim light.  Specifically, Mr. Wills' pupils measured 6.25 mm in dim light, while the laser treatment zone was only 5 mm in diameter.  With this combination of high myopia and a relatively large pupil, the use of a comparatively small diameter laser treatment zone was highly predictable to cause Mr. Wills to develop the residual visual problems from which he continues to suffer.  Moreover, this specific situation (i.e. high myopia and large pupil diameter relative to laser treatment zone) was well known, even in 1997, to result in the likely outcome of permanent problems of glare, halo, starburst, and ghost imaging phenomena.

In addition, based on my review of the medical records, depositions and ophthalmic examination, it is my opinion with a reasonable degree of medical certainty that Dr. Nevyas failed to obtain adequate informed consent from Mr. Wills for the LASIK procedures performed on 7 and 9 October 1997.  Specifically, before performing these surgical procedures, Dr. Nevyas should have advised Mr. Wills that given his clinical presentation (high myopia and relatively large pupil size) combined with the use of a comparatively small diameter laser treatment zone, it was highly likely (and a material risk) that he could develop permanent vision distortion including permanent and significant glare, halo, starburst and multiple ghost imaging problems.  This aspect of the consent is particularly relevant in light of Mr. Wills' pupil size plus high myopia and the treatment zone of the laser used by Dr. Nevyas to perform these procedures.  Furthermore, Dr. Nevyas failed to advise Mr. Wills that because of his high myopic condition requiring removal by laser ablations of a substantial amount of corneal tissue, that there would only be limited potential opportunity for future corrective surgeries to alleviate residual refractive error or visual distortions.  Indeed, the current thickness of Mr. Wills' corneas is at the limit beyond which additional laser treatment would be at risk to produce structural weakening with unpredictable anatomical and visual consequences.  Given the extensive material risks to this patient as described above, Dr. Nevyas' testimony that he advised Mr. Wills that he was simply at "increased risk" was entirely inadequate and demonstrated that Mr. Wills was not fully informed of the risks of the intended procedures, and thus, did not give informed consent to the laser surgical procedures performed.  Moreover, if as Mr. Wills testified that Dr. Nevyas assured him preoperatively there was virtually no chance of these risks occurring, then Mr. Wills was clearly not informed of the material risks of the intended procedures based on his clinical presentation.

I appreciate the opportunity to review this important case.

Sincerely,
Kenneth R. Kenyon, MD

Posted by Admin at March 1, 2003 03:01 PM