Radial Keratotomy (RK) - Eyes needlessly damaged

The two images below are of eyes that have had both, RK and LASIK. The photos were taken through a slit lamp (bio-microscope) after applying fluorescein stain on the eye. The green-yellow circle around the periphery of the cornea is the LASIK flap edge. The spoke-pattern is the RK incisions, which are clearly visible. The LASIK flap edge and RK incisions are staining green-yellow because the dye settles into the wounds which are not completely healed.

The next four images below also demonstrate that RK incisions never heal. These open portals can allow opportunistic organisms to enter the eye causing infections and inflammation. The first two photos are corneas 20 years after RK. The patient in the 4th image (bottom right in this section) had 2 RK procedures followed by 2 LASIK surgeries. The yellow-green
slits are openings in the cornea due to incomplete healing from the surgeries which were performed many years ago.

The image below-left shows the cornea of a patient who had 2 RK procedures in 1989 followed by LASIK in 2000. The green color around the LASIK flap indicates an opening in the seam of the flap. The green dye in the RK incisions indicates that these incisions are still open and placing the patient at risk for infection and inflammation.

Corneal ectasia can occur after Radial Keratotomy (RK) as well as after LASIK. The image below on the left shows the cornea of a patient with post-RK ectasia. The patient had RK in 1988. He began losing visual quality in 1990. In addition to the corneal protrusion, note the faint white spot at the apex of the curve. This is internal corneal tissue that is protruding out of one of the RK incisions.

The photograph below on the right is the cornea of a female patient who lost functional vision after RK 17 years ago. The RK incisions are unusually deep and long. Note how flat the cornea is along the visual axis with inferior steepening. The patient has recently been fit by Dr. Boshnick with a new specialty hard contact lens and has regained functional vision.

The image below-left is a photograph of the cornea of a patient who had RK eighteen years ago. In addition to the open radial cuts, the patient has an open horizontal incision. The dark blue oval area surrounding the horizontal cut is an area of corneal steepening (ectasia). The patient's vision with and without glasses is very poor. The patient requires a large rigid contact lens which vaults over the irregular corneal surface.

The image below-right is an RK cornea with highly unusual cuts.

The photo below-left shows open RK incisions 18 years after surgery. The image below-right shows another unusual RK cut pattern.

The cross sectional scan image below-left shows a cornea with very deep RK incisions. Note the incisions nearly penetrate the full thickness of the cornea. The image below-right shows a scleral lens on a post-RK cornea with open incisions. This cornea is unstable. Click on images for a larger view.

The two images directly below are photographs of the cornea of a female patient who had RK and consequently developed ectasia. This cornea is only 180 microns thick at the thinnest point. Average corneal thickness for normal eyes is approximately 550 microns. As you can see, the corneal surface is very irregular, which causes distorted vision. Click on the images for a larger view.

The image below on the left is a corneal topography of an eye that developed ectasia after RK and LASIK. This topography demonstrates a cornea with a very irregular surface full of hills and valleys and not smooth or spherical. The color blue represents the flatter areas of the cornea. Red represents the steepest area which is bulging or protruding. Corneal surface irregularity as illustrated results in visual distortion.

The image to the right is a corneal topography of a normal, unoperated eye for comparison.

The two images below are corneal topographies of eyes that have undergone two separate RK procedures followed by two separate LASIK procedures. As you can see, these corneas are highly irregular.

Two "successful" RK procedures, followed by "successful" LASIK surgery, followed by LASIK enhancement

Refractive Surgery "Nightmare" Reported to the FDA: RK Followed by PRK

In 1992, i lost my vision after refractive surgery - rk. In early october i had gone to a "free" seminar to gather info before i saw a dr. I had pre-existing scar tissue on my left eye but dr said "no problem", and we proceeded with bilateral refractive surgery. I did not have good vision from the start. I was told that "things have not settled down yet. We can always perform an enhancement. " i struggled with my duties at home and work. In 1993, i went to another city to see another dr -a referral from dr(first)-. He performed a prk on my left eye with later plans to surgically improve the right eye. At that time second dr told me that dr(first) made the cuts in my eyes too deep and too long. My left eye now had vision worse than pre-prk and was covered with scar tissue from the laser. In 1995, i went on medical leave from my surgical nursing position and had a corneal transplant. During that year, i filed for disability retirement. In 1996, i went to jury trial -case, medical malpractice. I was the victim made to look like a perpetrator. We lost the case and threw ourselves into debt. Dr(first) told me i was a good candidate for refractive surgery, that i would have good results and could throw away my glasses. He never told me there was no turning back from this surgery. He never mentioned the star burst, night blindness, double vision or painful dry eye. He never mentioned that i would not be able to care for my three children. I live the nightmare every day and cringe when i see the same advertising today as when i had my disastrous eye surgery. Source

FDA Complaint: Patient Deceived by Surgeon, Misleading Advertising of Refractive Surgery

I was talked into having rk-radial keratotomy- on my eyes by dr. He said, he never had a problem with any of his surgeries and guaranteed me a successful outcome. After the surgery, however, my eyes became very fatigued and sore. He said that i was reading from the twenty-twenty line on the eye chart and that this problem is in my head. He offered no support or guidance in this matter whatsoever, and practically dismissed me. I was shocked. Now i was left with sore, tired, fatigued eyes and no answers, since this was a new procedure in our area. So i began a journey to try and find a solution. This journey has taken me to numerous prominent eye surgeons. The have prescribed soft and hard contact lenses, glasses, performed ck-conductive keratoplasty-, lasik twice, and nothing has really corrected the problem. The pitfalls of corrective eye surgery need to be honestly discussed by these eye doctors, not covered up by misleading advertising and hype. Thank you for your time and concern in this matter. Source

RK Patient Files Report With FDA, Visually Impaired Since 1990

I had the rk surgery done in 1990 and, while the procedure was done years ago, i have decreased vision, halo effect, diminished night vision, and "dehabilitated" daytime vision. Source

Patient Injury Report Filed with FDA: Multiple RK Surgeries, Cataract Surgery, LASIK, and PRK

A surgeon reported concerns with clinical outcomes. A review of patient records provided, indicates one patient exhibited a loss of bcva following lasik surgery in the right eye only. This patient had multiple rk surgeries in the 1980's and 1990's and complained of ghosting, starbursts, halos and difficulty driving at night. He was diagnosed with nuclear sclerotic cataracts and experienced residual hyperoptic astigmatism after the rk surgeries. This patient underwent cataract extraction surgery with an iol implant prior to receiving lasik surgery. The patient's bcva prior to lasik surgery was 20/32. At 5 months post-op, the patient's bcva was 20/30-. A prk enhancement was performed at 13 months post-op lasik. At one month post-op prk enhancement, this patient's bcva was 20/50. Lasik after iol implantation is not an approved indication for this product. Source

Complications of small clear-zone radial keratotomy

PURPOSE: To review the postoperative outcome of patients with radial keratotomy who have clear-zone diameters below 2.75 mm.

METHODS: A retrospective review was performed of all patients with radial keratotomy who have clear-zone diameters less than 2.75 mm presenting for consultation from August 1993-September 1995. Preoperative records and surgical reports were reviewed, and a thorough ophthalmic examination was performed.

RESULTS: A total of 37 eyes had a clear-zone size below 2.25 mm. Six eyes were excluded from subsequent analysis due to keratoconus. The remaining 31 eyes had an average clear-zone size of 1.5 mm (standard deviation, 0.4 mm; range, 0.9-2.2 mm). Postoperative morbidity included severe disabling glare in 31 (100%) of 31 eyes, contact lens intolerance in 19 (100%) of the 19 eyes fitted, Snellen visual acuity loss (> 2 lines) in 25 (81%) of 31 eyes, inability to drive at night in 11 (69%) of 16 patients, moderate to severe diurnal visual fluctuation in 21 (68%) of 31 eyes, refractive undercorrection by greater than 1 diopter in 16 (52%) of 31 eyes, loss of employment in 4 (25%) of 16 patients, polyopia in 5 (16%) of 31 eyes, refractive overcorrection by greater than 1 diopter in 3 (10%) of 31 eyes, and a retinal detachment attributable to pilocarpine use in 1 (3%) of 31 eyes.

CONCLUSIONS: Using radial keratotomy clear-zone diameters smaller than 2.25 mm has a high complication rate and is unsafe. Small clear-zone radial keratotomy should be abandoned. Although this study was limited to clear zones less than 2.25 mm, the authors endorse current recommendations that the clear zone should be at least 3.0 mm in diameter.

Source: Grimmett MR, Holland EJ. Complications of small clear-zone radial keratotomy. Ophthalmology. 1996 Sep;103(9):1348-56.

Results of the prospective evaluation of radial keratotomy (PERK) study 10 years after surgery.

OBJECTIVE: To determine the long-term effects and stability of refraction following a standardized technique of radial keratotomy for myopia in the nine-center Prospective Evaluation of Radial Keratotomy (PERK) Study 10 years after surgery.

METHODS: Radial keratotomy using eight centripetal incisions was performed to reduce myopia of -2.00 to -8.75 diopters in 1982 and 1983. A mean of 10 years later, patients underwent a standardized ophthalmic examination similar to previous study examinations.

RESULTS: Of 427 patients (793 eyes that underwent radial keratotomy), 374 patients (88%) (693 eyes) returned for the 10-year examination. Of 675 eyes with refractive data, 38% had a refractive error within 0.50 D and 60% within 1.00 D. For 310 first-operated eyes, the mean refractive error was -0.36 D at 6 months and changed in a hyperopic direction to + 0.51 D at 10 years. The average rate of change was +0.21 D/y between 6 months and 2 years and +0.06 D/y between 2 and 10 years. Between 6 months and 10 years, the refractive error of 43% of eyes changed in the hyperopic direction by 1.00 D or more. The hyperopic shift was statistically associated with the diameter of the clear zone. Uncorrected visual acuity was 20/20 or better in 53% of 681 eyes and 20/40 or better in 85%. Loss of spectacle-corrected visual acuity of 2 lines or more on a Snellen chart occurred in 3% of all 793 eyes that underwent surgery. Among 310 patients with bilateral radial keratotomy, 70% reported not wearing spectacles or contact lenses for distance vision at 10 years.

CONCLUSION: The PERK technique of radial keratotomy eliminated distance optical correction in 70% of patients, with a reasonable level of safety. A shift of the refractive error in the hyperopic direction continued during the entire 10 years after surgery.

Source: Waring GO 3rd, Lynn MJ, McDonnell PJ. Arch Ophthalmol. 1994 Oct;112(10):1298-308.

The Casebeer system for predictable keratorefractive surgery. One-year evaluation of 205 consecutive eyes.

PURPOSE: This study documents the results of current radial keratotomy (RK) surgical technology, using the Casebeer keratorefractive system. These results are contrasted to those of the Prospective Evaluation of Radial Keratotomy (PERK) keratorefractive system, developed approximately 12 years ago.

METHODS: Two hundred five consecutive surgical procedures were examined, which was the first year of experience with RK for one of the authors (TPW). All procedures fit within the Casebeer nomograms. Enhancement procedures were performed following the Casebeer system nomograms.

RESULTS: Follow-up for 100% of patients was achieved. Postoperative cycloplegic refractions yielded an average of +0.27 +/- 0.58 diopters (D) of residual refractive correction (range, -0.88 to +2.50 D). One year postoperatively, 20/25 or better uncorrected visual acuity was achieved in 86% of patients and 20/40 or better uncorrected visual acuity was achieved in 99% of patients. Bothersome but not incapacitating side effects, such as glare, starbursting, and fluctuating vision, have been commonly observed with RK.

CONCLUSION: The Casebeer system for keratorefractive surgery, which is easy to learn, can yield an extremely accurate surgical result. The major reason for increased accuracy compared with the PERK system is the surgeon's ability to titrate the primary surgical procedure with enhancement operations. Although RK is by no means a perfect surgical technique, side effects tend to be relatively minimal, and patient satisfaction tends to be extremely high.

Source: Werblin TP, Stafford GM. Ophthalmology. 1993 Jul;100(7):1095-102.

Corneal ectasia as a complication of repeated keratotomy surgery

BACKGROUND: Staged keratotomy surgery, or "enhancement surgery," may allow a more predictable outcome, but also subjects the patient to additional surgical risks.

METHODS: A 39-year-old man underwent astigmatic keratotomy for myopic astigmatism, followed by 12 enhancement procedures for residual astigmatism.

RESULTS: These procedures effectively resulted in a double hexagonal keratotomy. The patient's best spectacle-corrected acuity deteriorated to counting fingers. Clinically, a conically-shaped protrusion of the central cornea, Munson's sign, diffuse subepithelial scarring, and central corneal thinning were noted. Penetrating keratoplasty was performed. Histopathologic examination showed central thinning, epithelial edema, disruption of Bowman's layer, marked stromal scarring, and focal areas of endothelial attenuation--findings consistent with keratoconus.

CONCLUSION: This case illustrates that multiple keratotomy procedures may result in corneal ectasia in apparently normal eyes and suggests that hexagonal keratotomy may be more likely to cause iatrogenic keratoconus.

Source: Wellish KL, Glasgow BJ, Beltran F, Maloney RK. Refract Corneal Surg. 1994 May-Jun;10(3):360-4.

Iatrogenic keratoconus as a complication of radial keratotomy

A 47-year-old man with a family history of keratoconus had uneventful bilateral radial keratotomy (RK) with astigmatic keratotomy (AK) enhancements 12 years earlier. He noticed a gradual onset of blurry vision with progressively increasing myopic shift. Visual acuity remained poor even with spectacles or soft contact lenses. Slitlamp examination revealed 16 well-healed RK scars and 2 AK scars with marked corneal steepening inferiorly in an area of astigmatic enhancement in the left eye but an otherwise normal fellow eye with 16 well-healed RK scars. He subsequently had penetrating keratoplasty for decreased vision not correctable by rigid gas-permeable contact lenses. Microscopic examination of the corneal button showed findings consistent with keratoconus. This case represents the first documented incidence of corneal ectasia as a complication of primary RK.

Source: Shaikh S, Shaikh NM, Manche E. Iatrogenic keratoconus as a complication of radial keratotomy. J Cataract Refract Surg. 2002 Mar;28(3):553-5.

Complicated flap creation with femtosecond laser after radial keratotomy

PURPOSE: To report a case of laser in situ keratomileusis (LASIK) that used the Intralase femtosecond laser 14 years after radial keratotomy (RK) for residual myopic astigmatism.

METHODS: A 39 year-old male patient had undergone a bilateral RK operation for myopic correction. The manifest refraction was -1.25 -3.00 x 175 D, with uncorrected visual acuity (UCVA) of 20/50 and best-corrected visual acuity (BCVA) of 20/20. The central and thinnest pachymetry measurements were 582 and 576 mum, respectively, by Orbscan II.

RESULTS: Intralase was used for LASIK, and initially, a loss of suction was seen during flap formation. The flap could be created again at the same intracorneal plane. During flap lifting, the RK incisions were separated, and one of the RK incisions progressed to the corneal center with the force applied by the blunt spatula. No piece was separated completely from the flap. Excimer laser treatment and flap repositioning could be done without any problems. At the fifth postoperative month, his UCVA was 20/20. All RK incisions seemed well aligned. There was no haze or epithelial ingrowth.

CONCLUSIONS: This case showed that the Intralase femtosecond laser not only has no unique benefit as opposed to the mechanical keratome for post-RK eyes but also can lead to serious complications. We recommend that femtosecond laser flap formation not be used in post-RK eyes.

Source: Cornea. 2007 Oct;26(9):1138-40. Perente I, Utine CA, Cakir H, Yilmaz OF.