Texas Optometry Board
March 16, 2012

RE:
TOB#2011-11164, Tom Ballard, O.D.


Dear Mr. Kloeris,

I respectfully request the opportunity to speak with you or the Texas Optometry board in person to appeal the decision to close complaint TOB#2011-11164, Tom Ballard, O.D.

The responses provided to you by Tom Ballard, OD are inaccurate, false, and in some instances side stepped my claims all together. It also appears that his responses were provided prior to reviewing the additional information I submitted by email to Dennis Riggins on 2/21/2012. The investigation should not have been closed prior to receiving additional responses from Tom Ballard, OD to my supplementary submission. I have addressed the responses provided to you by Tom Ballard, OD below. I have numbered my responses in accordance with Tom Ballard's response.

Please note that the basis of my complaint is not solely due to my poor surgical outcomes. Even with a "perfect" visual outcome I would still be addressing the Texas Optometry Board regarding many of Dr. Tom Ballard's actions.

1. I did not misstate or misrepresent the preoperative exam discussion I had with Tom Ballard, OD. No claim was made that we discussed CustomVue vs. conventional LASIK prior to the first surgery. I claim it was implied that I would received the CustomVue procedure based on the written price quote I was given at that visit. It was during the first preoperative exam on 2/9/2010 that I was given a written price quote for CUSTOM LASIK. There is only one custom LASIK procedure performed at First Eye Care Dallas, which is CUSTOM VUE. Therefore it was implied that CustomVUE software would be utilized for the procedure. Price quoting "Custom" LASIK and performing "Conventional" LASIK is fraud, a criminal offense. This cannot be ignored. Giving me a written price quote for "Custom LASIK" indicated I would receive which procedure if it was not CustomVue? There is nothing custom about conventional LASIK. Misrepresenting the type of LASIK procedure I would receive and/or committing fraud does demonstrate that the license holder has engaged in a willful provision of substandard care.

It is true that the first time I was aware that conventional LASIK software was used was after the surgery. During an appointment with [Name Removed], OD for a second opinion of my vision issues I was informed that I received a conventional LASIK treatment. It was after that discussion with [Name Removed]  that I specifically asked Tom Ballard, OD if I received a Custom wavefront guided LASIK treatment and his response was "Yes". This was an outright lie, as I did not receive custom LASIK.

If the decision was made in conjunction with the surgeon, Larry R. Taub, MD to perform conventional LASIK, it was their responsibility to discuss this further with me. Again, I was given a written price quote for Custom LASIK, not conventional LASIK.
2.
  Tom Ballard did indeed explain to me that there was a difference between the records as they are displayed on the computer screen and the printed copy. I also asked him on one occasion to show me the complete records to confirm that my vision complaints were fully captured. He would not pull up my records on the computer that was within arms length. He did call me the next day to assure me that my records were complete. Additionally, the section listing medications is clearly visible on the printed version. Both my wife and I mentioned my prescription medication, which was never added. This medication was disclosed to Dr. Ballard's staff prior to the surgery as well as numerous times afterwards. I also directly confronted Dr. Ballard about the absence of this medication in my records. I have records dated as late a 3/30/2011 and this medication was still not added. I still claim that his records were incomplete.

Yes, I was angry during this visit and still am. My vision has been permanently damaged by Dr. Ballard and his surgeon Dr. Taub. Dr. Ballard should understand that if he intentionally deceives his patients and they are injured, they might confront him and demand answers.

3.
  I strongly dispute Dr. Ballard's claim that he did not provide false or misleading information about his LASIK success rates.

When I asked Dr. Ballard about his success rates he orally gave me the success rates listed on his website. The information on his website was old data from 2004. The degree of myopia corrected was also -1.47 to -5.92. My degree of myopia was -7.50 for contact lenses. Research supports that as the level of myopia increases, the probability of a successful surgical outcome decrease. The data was also for the CustomVue procedure, which again, I did not receive. Therefore the success rates Dr. Ballard gave me were in no way indicative of my expected surgical outcome, and were misleading and false.

Promoting success rates based on Snellen visual acuity alone is deceptive and dishonest. LASIK surgeons and optometrists who treat LASIK patients are well aware that higher order aberrations (HOAs) are the primary cause of vision complaints amongst post LASIK patients. HOAs can cause significant vision problems without affecting visual acuity as measured by a Snellen eye chart. I myself have firsthand experience with this. HOAs have disrupted my vision to the point where I have difficulty performing my job and enjoying life. HOAs cannot be completely resolved with the use of contact lenses, and glasses provide even less vision improvement. I did not have any history of depression prior to having my vision permanently damaged. Yet by Dr. Ballard's definition of success using Snellen visual acuity, my surgical outcome too was a success. Do you think the general public, or anyone else for that matter would view my surgical outcome as a success?

All LASIK procedures, regardless if conventional or custom, will increase higher order aberrations when compared to the unoperated on eyes. That makes it a relevant side effect or complication of the procedure which must be disclosed.
Not disclosing this information is a willful provision of substandard care. Omitting information regarding the contributions of HOAs to vision quality is dishonest and prevents a patient from being properly informed to provide informed consent.

Simply listing the possibilities of complications such as glare, halos, starbursts, etc. is not sufficiently informing a patient when they are at an elevated risk of experiencing such issues. I was at a much higher risk for having night vision complications that someone within the myopic range listed on Dr. Ballard's website. I was not informed of this.

I strongly dispute Dr. Ballard's claim that they were very conscientious about their disclosures and informed consent as he stated in his response to the Texas Optometry Board. Below are a few such examples:

  •         The informed consent presented to me prior to the first surgery did not disclose that the corneal flap could easily be lifted for many years following the surgery. This was only disclosed to me six months after the first surgery, when reviewing the second consent form. This is something the general public should be aware of as it would affect people's decisions to have this surgery. I would not have had the surgery due to my participation in boxing.

  •         Neither informed consent indicated that the corneal flap would no longer contribute significantly to the structural integrity of the cornea, and that research has demonstrated that the cornea heals incompletely and that the scar created only provides approximately 2.4% the strength of the preoperative corneal tissue. This is a side effect that every LASIK patient will experience, and therefore it would have been disclosed if he made any attempt at all to properly inform his patients. Instead he used wording such as "The eye may be more fragile to trauma" or and "That the treated eye, therefore, is somewhat more vulnerable to all varieties of injuries, atleast for the first year following LASIK". The truth is that the eye will permanently be more susceptible to injuries for the remainder of the patient's life. The eye will not be "somewhat" more vulnerable as Dr. Ballard states, but significantly more vulnerable.  Research has proven that the corneal flap no longer contributes significantly to the structural integrity of the cornea and that the scar from LASIK only heals to approximately 2.4% of its pre-surgical strength. My overall cornea strength was reduced by approximately 45%. This was determined using a pre-surgical cornea thickness of approximately 520 microns as indicated on a report by [Name Removed] and the residual bed thickness of only 286 microns for one of my eyes as measured by a Visante OCT. Again, if properly informed I would not have had the surgery due to my participation in boxing, and due to the large decrease in overall corneal strength. Performing LASIK on anyone participating in a sport such as boxing should be a criminal offense as it demonstrates gross negligence.




  •         The informed consent form presented to me prior to the first surgery did not disclose that increased degree of correction would increase the healing time. This was important as my decision to have surgery would have been postponed due to vacation plans my wife and I had. My vacation was ruined due to poor, fluctuating vision.

  •         The informed consent form presented to me prior to the first surgery did not disclose that a high degree of correction or large pupil size increased risks associated with night vision disturbances such as halos, starbursts, and glare.

  •         Neither informed consent disclosed information about an increase in higher order aberrations. HOAs have a significant impact on vision quality. All LASIK procedures increase HOAs of an unoperated on eye. An increase in HOAs causes a decrease in vision quality. Every LASIK patient will experience some level of decreased vision quality, sometimes referred to as LASIK 20/20.

4.  My level of myopia was within the range to expect a good LASIK outcome if a good outcome was only defined as a measure of visual acuity using the Snellen eye chart. Below I have addressed each of Dr. Ballard's bulleted responses.

  •         Dr. Ballard stated within his response to the Texas Optometry Board that "Simply by nature of his moderately high level of myopia, he had an increased risk of a retinal detachment compared to the emmetropic population". I was never informed that I was at an increased risk. Medical research also supports that my high level of myopia is also responsible for the large number of vitreous eye floaters I now have. Many of these floaters are in focus, indicating they are close to the retina.  I did not have these floater prior to LASIK.

  •         In Dr. Ballard's response, he stated that "The ablation zone (including blend) more than covers his worst case scotopic pupil size". It is important to note that the "blend" or blend zone is not a fully corrected optical zone. In order to preserve vision quality and prevent night vision issues, the fully corrected optical zone must be larger than the scotopic pupil size. Blend zones do not count! Blend zones reduce stray light from entering the pupil from outside the pupil diameter by eliminating an abrupt transition from the fully corrected zone to the uncorrected zone. A blend zone will still induce stray and unfocused light if the entrance pupil extends into the blend zone. This will always decrease vision quality. Dr. Ballard also stated that my "Pupil size was not a significant factor in his complaints as shown by non-improvement with the trial of reducing the pupil diameter via Pilocarpine and Alphagan P". This is false. The use of Alphagan P changed the shape and size of the vision aberrations and reduced them by a small degree. This however was performed at the same time Dr. Ballard had me trying multiple pairs of rigid contact lenses which induced additional aberrations. The use of Alphagan P had a significant impact on the reduction of dim/dark vision disturbances once the improperly fitting contact lenses were replaced with properly fit lenses by another doctor.
I continue to depend on the use of Alphagan P every morning and every evening in order to see well enough in dim/dark lighting conditions to drive myself to work, watch with the lights out, or to work in dark conditions as I sometimes must do. My vision is not corrected alone with the use of Alphagan P due to the combination of a flattened cornea due to the high degree of correction combined with corneal irregularities that are centrally located within my constricted pupil diameter.

  •         I find it difficult to believe that Dr Ballard does not recall the conversations we had about my participation in boxing. This most certainly was discussed during my appointment with him on 3/23/2010 when I signed the first consent form and was informed that the eye is "somewhat" more vulnerable to injury after LASIK. My wife and I also discussed this with the surgeon, Dr. Taub prior to surgery. Dr. Taub also reassured me that boxing was still safe after LASIK. It is not safe for me to participate in boxing. Many of the doctors I have been referred to have warned me to no longer participate as it is now not safe. Some of these are doctors I was referred to by Dr. Ballard.

  •         As previously mentioned, the overall strength of my corneas has been reduced by approximately 45%, the corneal scar is only approximately 2.4% its original strength which makes flap dislocation a serious concern when boxing, and I now have to wear hybrid contact lenses which are rigid in the center. If I were hit in the eye while wearing these contact lenses my corneas would most certainly be damaged.

5. I strongly disagree with Dr. Ballard's assertion that I did not receive deficient follow-up care. Below I have addressed each of Dr. Ballard's bulleted responses. Being provide glasses that do not correct my vision, or being provided improperly fit contact lenses does not demonstrate adequate follow up care, and most certainly does not demonstrate that Dr. Ballard went above and beyond.

  •         Dr. Ballard stated in his response to the Texas Optometry Board that there "is no notation in our records that he indicated in any way that he felt unsafe to drive". Again, this supports my claim that Dr. Ballard's records are incomplete. I most certainly informed the doctor I met with that I had difficulty driving and felt unsafe. They never informed me that my visual acuity was 20/70, making it illegal for me to drive. Why wasn't I informed that I could not legally drive?

  •         Dr. Ballard stated in his response to the Texas Optometry Board "It was difficult to understand his level of complaint since his Snellen acuity was so good (20/20)". There are quantitative approaches such as reviewing the measured higher order aberration values that would help indicate the negative impact on vision quality that was missed by Snellen acuity testing. There are additional features of the VISX software such as point spread functions that gives a visual representation of how I see a point light source through my damaged corneas. This would have given Dr. Ballard an "understanding" of my visual disturbances. Dr. Ballard chose not to utilize tools available to better understand and treat my vision complications. My post surgical wavescans indicated measurable and substantial increases in higher order aberrations after having LASIK. This was due to LASIK induced defects in my corneas. Evaluation of my corneas should have been performed using an optical zone of over 7.9mm, not 6.5mm as was often used, as my pupil size measured as large as 7.9mm. Using a smaller aperture gives a false indication of my vision as seen in dim/dark conditions.

  •         Dr. Ballard stated "Mike was never denied his right to see the surgeon", and that the return call from his office "was to clarify the purpose the appointment and to coordinate care between offices". I was called back by Dr. Ballard's LASIK coordinator and questioned in a confrontational manner about why I called the surgeon's office. I was then told to wait until my next follow up appointment. That can be interpreted as nothing other than denying me the right to be seen by my surgeon. There was absolutely no attempt to coordinate care during this call.

  •         I was provided expired medication by Dr. Ballard's surgeon. Prior to each surgery I signed additional consent forms stating that Dr. Ballard and Dr. Taub were the "Team" responsible for my care. They should therefore both be held equally accountable for each others actions regarding my care.

  •         Dr. Ballard stated that "The irregularities in his post op corneal topographies are subtle, At the time, it did not appear that they adequately explained his symptoms". Again, the zone diameters that were measured by Dr. Ballard's staff were approximately 6.5mm in diameter. With a pupil diameter as large as 7.9mm, only approximately 67% of my pupil topography is being evaluated. This masked the additional higher order aberrations induced by the inadequately sized fully corrected optical zone of the procedures. This type of insufficient data collection and evaluation is inadequate care.

6.  Dr. Ballard's response is a lie. I did confront Dr. Ballard regarding performing the surgeries in view of they lobby and allowing spectators to watch from a viewing area. This practice gives the false appearance that the surgery is safe and without risk. When I asked Dr. Ballard about their decision to allow spectators to view the surgeries and expressed my concern of how I felt tricked by the practice, he stated they do this so others are aware that they have the capability. I'm pretty sure the name "First Eye Care Infinity Laser Vision" implies that.

Also included in Dr. Ballard's response was the statement that "No patient's names are visible to the public". This was not part of my complaint, but is also a false statement. The names of patients having surgery were clearly visible to the public when standing at the front counter. The names were printed on a paper that was on the lower portion of the front desk in front of the girls who worked there. The names of those who arrived for or had the surgery prior to me earlier in the day were highlighted, and were clearly visible.

2/9/2010
I disagree with Dr. Ballard's claim that he did not make any representation or guarantee of a specific outcome. I specifically asked Dr. Ballard if I would have night vision issues such as halos, or starbursts. He specifically stated that they would be no worse than with my current contact lenses. He did not use the words "typical" or "usually" when answering this question. His consent form prior to the first surgery did not disclose that the high degrees of correction or large pupil size would contribute to these issues.

In addition to discussing night vision issues, I made my expectations clear to Dr. Ballard. I told him if there was a real chance that I would need glasses or contacts after the procedure I was not interested. He has stated that he did not understand what was meant by this statement. Research shows that nearly half of all individuals who have LASIK require the use of glasses or contact lenses to correct their vision within a few years of the procedure. That would make it a real possibility. I now personally know 9 individuals who have had LASIK. Five of those individuals now required glasses or contacts to correct their vision. Two of these individuals are doctors, and one is Dr. Ballard who informed me that he now wears a contact lens in one eye after an infection from a scratch caused DLK.

If my expectations were unrealistic it was Dr. Ballard's responsibility as a medical professional to inform me that I was not a good candidate for the procedure. I did not consent to a surgery with such a high regression rate. I was not willing to take such risks for a temporary reduction of needing glasses or contact lenses.

3/23/2010 As mentioned previously, I discussed my participation in boxing with Dr. Ballard at this appointment after reading the informed consent. This was also discussed further with the surgeon, Dr. Larry Taub, both prior to the first surgery and after the second surgery. Up until the last time I spoke with Dr. Taub he had assured me it was safe to participate in boxing.

March 2010-November 2010 Dr. Ballard claimed that I "had no significant measurable vision problems as time went on during this period". This is false. Not only did I continue to mention my poor vision at every single appointment, but my vision also continuously fluctuated throughout each day. With the proper utilization of VISX software and other tools available through other doctors, a significant amount of data could have been collected and used to provide me with helpful follow up care. Instead I was always told to simply give it time, use eye drops, etc. Dr. Ballard could have performed morning, afternoon, and evening refractions and wavescans to help identify the root cause of my extreme vision fluctuations. Instead he chose to blame it on dryness, which was not the cause as indicated my tear film break up times, and the absence of improved vision after months of using Restasis.

Dr. Ballard also stated that they have provided me with glasses and multiple pairs of contact lenses at no charge. This was true. Dr. Ballard provided me with a pair of glasses one week after the first surgery. The glasses only helped during a small window of the day as my vision fluctuated greatly throughout the day.
I was provided with multiple pairs of rigid contact lenses which distorted my vision both during use and after removal. I was never able to tolerate these lenses for more than a few hours, and they induced additional dim/dark lighting condition vision issues. This complicated the evaluation of using Alphagan P to reduce night vision issues. The Synergeyes contact lenses I was provided with at Dr. Ballard's office were not fit properly, and were not appropriate for my post surgical corneas. The lenses corrected my vision by applying significant pressure to the surfaces of my corneas. While it gave improved, but not corrected vision during use, my vision was severely distorted upon removal of the contact lenses. The use of these improperly fit lenses is likely what led to the multiple inflammations of one of my corneas, resulting in further reduced vision and the inability to perform my job duties or be independent.

I was not properly informed, and therefore could not possibly provide informed consent to having LASIK. As previously mentioned I was not properly informed of many relevant risks and how they related directly to my pupil size and degree of correction. I also did not consent to having a surgery that would significantly weaken my corneas, or leave me significantly more susceptible to vision threatening injuries for the rest of my life. I did not consent to a surgery that always leaves corneas with permanent incompletely healed scars. I did not consent to a surgery where the cornea flap would no longer contribute to the structural integrity of my corneas. I also did not consent to a procedure that would be performed based on inadequate screening processes.

In closing I am still very angry about my permanently damaged vision and how I was deceived prior to having surgery. I am angry that after nearly two years of coping with permanently damaged vision I continue having to put so much effort into trying to get a proper investigation of Dr. Ballard and Dr. Taub. I am also angry that I now bounce from one optometrist or ophthalmologist to another without any resolution to correcting my permanently damaged vision, when prior to LASIK I only required the use of disposable soft contact lenses that cost me $10 a pair.

This worthless and misrepresented surgery has cost me a lifetime of happiness with my wife, family, and friends. I spend every single day fluctuating between anger and depression. This is my life now. I am unable to enjoy the benefits of having a successful career as a mechanical engineer. I was never like this before my vision was damaged.

The LASIK industry lack the transparency required to ensure adequate patient protection and care. Expectations are unrealistic due to inappropriate and inflated claims of success based on Snellen visual acuity. Dr. Ballard has contributed to this flood of misinformation. There appears to be few established standards of care. This allows for poor surgical outcomes to nearly always be blamed on unforeseen healing complications, even when a preponderance of research based evidence indicates that the poor outcomes could have easily been predicted and avoided through proper screening.
Tort reform further masks the extent of the problem and the number of injured patients like myself by preventing them from filing the appropriate lawsuits that would hold dishonest and negligent doctors accountable. Proper investigation and punishment of doctors is further hampered by the classic fox guarding the hen house. All LASIK cases are reviewed by optometrists and ophthalmologists who are engaged in LASIK, and therefore share a financial interest in protecting the industry. How am I supposed to receive a fair and thorough investigation with such conflicts of interest?

I am committed to pursuing every legal avenue in order to ensure that Tom Ballard, OD is held accountable for the permanent damaged they have inflicted to my eyes. My efforts will include complaints to the Texas Optometry Board, The Federal Trade Commission, the Better Business Bureau, and the Texas Attorney General. I will also utilize online communications such as personal websites, public message forums, and public business/service review sites. Additional communications will include contacting local news agencies with my story, and distributing printed copies of my story or protesting in front of the business of Tom Ballard, OD on the days they are to perform LASIK surgeries.

I have included the following documents:

  •         Copies of my consent forms
  •         Copies of some of my wavefront scans
  •         Copies of my Visante OCT scans
  •         Various studies gathered from the National Center for Biotechnology Information (<http://www.ncbi.nlm.nih.gov>)


Regards,