Problems from Lasik? File a MedWatch report with the FDA online. Alternatively, you may call FDA at 1-800-FDA-1088 to report by telephone, download the paper form and either fax it to 1-800-FDA-0178 or mail it to the address shown at the bottom of page 3, or download the MedWatcher Mobile App for reporting LASIK problems to the FDA using a smart phone or tablet. Read a sample of LASIK injury reports currently on file with the FDA.
Patients with LASIK complications are invited to join the discussion on FaceBook
Past President of American Glaucoma Society warns of risk of vision loss from undiagnosed glaucoma after LASIK
From the article: But as a glaucoma specialist and past president of the American Glaucoma Society, Dr. Lewis is keenly aware of the difficulty [LASIK] presents for accurately diagnosing glaucoma. "Our ability to diagnose and observe patients with glaucoma after refractive surgery is in doubt," Dr. Lewis observed in an editorial several years ago. He is still sounding the alarm.
E-mail from medical doctor who suffered vision loss after LASIK - 1/17/2013
I would not have discovered that I had glaucoma after LASIK, if I had not been tested with Ocular Coherence Tomography [OCT]. Conventional Goldman applanation tonometry (the gold standard for glaucoma detection) is notoriously inaccurate after LASIK. Other clinical features like fundoscopy and visual field confrontation were undiagnostic in my case. The OCT looking at my optic nerve and retina demonstrate the severe damage that has already occurred due to glaucoma, specifically the pathological loss of optic nerve fiber thickness in three of the four quadrants of each of my optic nerves. It also demonstrated PVD in my left eye.
I encourage any post-LASIK patient to familiarize themselves with the known inability to accurately measure IOP in post LASIK patients using conventional techniques. I now have an additional permanent vision loss after LASIK. In my opinion any patient who has LASIK should be followed by a glaucoma specialist, as they are the only doctors who have the equipment that could have diagnosed my problem sooner and prevented my irreversible vision loss.
Due to the complicity of the FDA in not warning the public, many people never realize the damage LASIK has done to them.
Complication cascade after hyperopic LASIK.
Ophthalmologe. 2011 Apr 13. Handzel DM, Stanzel BV, Briesen S.
Augenklinik Dardenne, Friedrich-Ebert-Str. 23-25, 53177, Bonn, Deutschland, handzel@dardenne.de.
Abstract: This report concerns the case of a 28-year-old female patient who was treated with topical steroids for 2 years following complicated hyperopic LASIK surgery with a re-treatment including a re-lift of the flap. A steroid-induced rise in the intraocular pressure (IOP) was subsequently observed on the treated eye, together with a glaucomatous subtotal destruction of the optic nerve, resulting in a residual vision of 1/15. An erroneously low IOP measurement, which was probably the reason for the delay in detecting steroid-induced glaucoma, has been reported in several cases concerning LASIK patients. The reason for the unusually severe course in the case in question can only be presumed, namely a possible accumulation of fluid at the interface or altered biomechanics following hyperopic LASIK surgery. The need for a thorough postoperative examination following refractive surgery must be emphasized. This case shows a cascade of complications following hyperopic LASIK surgery resulting in the functional blindness of one eye.
Nonarteritic ischemic optic neuropathy after LASIK with femtosecond laser flap creation.
Maden A, Yilmaz S, Yurdakul NS. J Neuroophthalmol. 2008 Sep;28(3):242-3.
Excerpts:
We examined a 53-year-old man who developed unilateral NAION after bilateral simultaneous uncomplicated hyperopic LASIK in which flap creation was performed using the IntraLase femtosecond laser (IntraLase Corp., Irvine, CA) with a low-pressure suction ring.
On the first postoperative day, best-corrected visual acuities were 20/20 in the right eye and 20/200 in the left eye. The right optic disc was normal, and the left optic disc was edematous. There was a relative afferent pupillary defect in the left eye. Visual field examination showed a dense nerve fiber bundle defect in the left eye (Fig. 1).
Thorough evaluation of glaucoma patients vital before refractive procedures
OSN SuperSite Top Story 6/17/2008
From the article: In addition, he noted the importance of avoiding, if possible, any type of microkeratome suction ring in eyes with optic neuropathy, as the rings are designed to increase IOP, which could lead to visual field loss after refractive procedures.
Surgeons must be aware of glaucoma risk after refractive surgery
OSN SuperSite Top Story 3/25/2008
From the article: The risk of glaucoma after refractive surgery procedures should not be underestimated, according to one surgeon speaking here at the Alicante Refractiva International meeting. "I have to play the part of devil's advocate by speaking about this topic in a refractive surgery meeting," said José Belda, MD, of Vissum Institute in Alicante. "Still, we have to consider that what we see is only the tip of the iceberg, and below it we may have a large quantity of patients presenting this problem in the future..." Meanwhile, suction can be a problem with LASIK. The vacuum phase is short, but pressure values are high — between 60 mm Hg and 90 mm Hg — and can reach as high as 200 mm Hg as the blade presses against the cornea, according to Dr. Belda.
Am J Ophthalmol. 2000 May;129(5):668-71.
Visual field defect associated with laser in situ keratomileusis.
Bushley DM, Parmley VC, Paglen P.
Department of Ophthalmology, Madigan Army Medical Center, Tacoma, Washington 98431, USA. mbushley@aol.com
PURPOSE: To report a case of visual field defect associated with laser in situ keratomileusis.
METHODS: Case report. A 28-year-old woman with high myopia (-10D) and a family history of normal tension glaucoma underwent bilateral laser in situ keratomileusis keratorefractive surgery. Preoperatively, both eyes had normal intraocular pressure and visual field.
RESULTS: At the first postoperative visit 1 day after apparently uncomplicated laser in situ keratomileusis, the patient reported a scotoma in the right eye. At 3-month follow-up, visual fields revealed the patient had developed a near-superior altitudinal visual field defect in the right eye. The defect did not progress over 1 year of follow-up examinations.
CONCLUSION: Increased intraocular pressure associated with the microkeratome vacuum ring used during laser in situ keratomileusis may have precipitated optic nerve head ischemia and visual field defect.
Ophthalmology 2001 Apr;108(4):660-5
Laser in situ keratomileusis-induced optic neuropathy.
Cameron BD, Saffra NA, Strominger MB.
Division of Ophthalmology, Maimonides Medical Center, Brooklyn, New York. Department of Ophthalmology, NYU Medical
Center, New York, New York. Department of Ophthalmology, SUNY Health Science Center at Brooklyn, Brooklyn, New York.
OBJECTIVE: To report a case of bilateral optic neuropathy after bilateral laser-assisted in situ keratomileusis (LASIK) surgery.
DESIGN: Observational case report.
METHODS: Complete eye examination with detailed evaluation of the optic nerve, detailed medical history, stereo disc photographs, GDx Nerve Fiber Analyzer testing, Humphrey 24-2 SITA visual field testing, diurnal intraocular pressure measurement, serologic evaluation, and magnetic resonance imaging of the brain and orbits.
MAIN OUTCOME MEASURES: Optic nerve status, visual field status, and visual acuity.
RESULTS: A subject with previously healthy optic nerves had bilateral optic neuropathy develop after LASIK surgery. This neuropathy manifested with a subjective decrease in visual field, normal visual acuity, normal color vision, relative afferent pupillary defect, increased cupping of the optic nerve with focal neuroretinal rim defects, decreased nerve fiber layer thickness, and nerve fiber bundle-type visual field defects. The subject had no other risk factors for optic neuropathy. No other cause of neuropathy was identified.
CONCLUSIONS: Optic neuropathy is a potential vision-threatening complication of LASIK surgery. This complication may be due to barotrauma or ischemia related to extreme elevation of intraocular pressure by the suction ring. Careful examination of the optic nerve before and after LASIK surgery is warranted.
Can J Ophthalmol. 2007 Feb;42(1):123-4.
Optic pit maculopathy after laser-assisted in situ keratomileusis.
Rodriguez-Coleman H, Schiff WM, Hwang JC, Speaker MG.
National Eye Institute, National Institutes of Health, Bethesda, MD, USA.
CASE REPORT: Optic disc pit is an embryological malformation of the optic nerve that occurs in less than one in 10,000 people. It is 10%-15% bilateral, and 25% to 70% of patients develop a neurosensory macular detachment within the 2nd to 4th decade. COMMENTS: We report a case of unilateral optic disc pit maculopathy 2 months after laser-assisted in situ keratomileusis (LASIK) revision.
Ophthalmic Surg Lasers Imaging. 2003 Jul-Aug;34(4):334-41.
Acute conformational changes in the optic nerve head with rapid intraocular pressure elevation: implications for LASIK surgery.
Piette S, Liebmann JM, Ishikawa H, Gürses-Ozden R, Buxton D, Ritch R.
Department of Ophthalmology, The New York Eye and Ear Infirmary, New York 10003, USA.
BACKGROUND AND OBJECTIVE: To investigate the effects of acute intraocular pressure (IOP) elevation on optic disc morphology.
PATIENTS AND METHODS: Ophthalmodynamometry was used to increase the IOP of normal, healthy eyes. Confocal scanning laser ophthalmoscopy of the optic nerve head using the Heidelberg Retinal Tomograph II (Heidelberg GmbH, Heidelberg, Germany) and IOP measurements were obtained before, during, and after IOP elevation.
RESULTS: Sixteen eyes of 16 normal volunteers (mean age, 32.8 +/- 11.9 years) were enrolled. Rim area, rim volume, cup area, cup volume, cup-to-disc ratio, mean cup depth, maximum cup depth, mean retinal nerve fiber layer (RNFL) thickness, and RNFL cross-sectional area showed significant changes during IOP elevation (all P < .05, paired t test). All measured parameters returned to their original values after pressure resolution (all P > .2) except mean RNFL thickness (P = .03).
CONCLUSION: Transient elevation of IOP results in measurable alterations in optic nerve head topography.
J Cataract Refract Surg. 2000 Nov;26(11):1581-4.
Optic neuropathy associated with laser in situ keratomileusis.
Lee AG, Kohnen T, Ebner R, Bennett JL, Miller NR, Carlow TJ, Koch DD.
Department of Ophthalmology, The University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA.
PURPOSE: To report 4 cases of optic neuropathy following laser in situ keratomileusis (LASIK).
SETTING: Tertiary Care ophthalmic practices.
METHODS: In this retrospective observational case series, 4 patients who developed acute visual loss following LASIK are reported. All had clinical evidence of optic neuropathy. Two had optic disc edema and 2 had normal appearing optic discs initially. None of the patients experienced significant visual recovery, and all developed optic atrophy in the affected eye.
RESULTS: All patients had evaluations for alternative etiologies of their optic neuropathy, with negative results. All patients were therefore presumed to have experienced an ischemic optic neuropathy following LASIK.
CONCLUSIONS: Patients who have LASIK may experience an acute anterior or retrobulbar optic neuropathy. The etiology is unknown but may be related to the marked increase in intraocular pressure that occurs during a portion of the procedure.
Disclaimer: The information contained on this web site is presented for the purpose of warning people about LASIK complications prior to surgery. LASIK patients experiencing problems should seek the advice of a physician.