Tuesday, June 19, 2018

Dry Eye After LASIK (Laser-assisted in situ keratomileusis)


LASIK is NOT 100% safe.

Patients has been complaining for years about their dry eye symptoms and corneal aberration issues, such as burning, tearing, pain, halos, and glare after LASIK. Not everyone who gets LASIK has dry eyes or corneal aberration issues afterwards, but it has been estimated that about 95-97% of patients get some form of dry eye immediately after LASIK (Ref 1), 60% of patients 1 month post-surgery, and 10%–40% of patients have chronic (lasts at least 6 months) dry eye after LASIK or PRK (Ref 2-4). Studies have also shown the risk of immediate dry eye and chronic dry eye after PRK is not less than LASIK.

More and more patients are noting the despair they feel from chronic dry eye after LASIK/PRK.
A recent New York Times article highlights this https://mobile.nytimes.com/2018/06/11/well/lasik-complications-vision.html

This is a photo of the standard cornea cut for a LASIK procedure. About 260 degrees of corneal nerve tissue is cut in the process. 


The recent March For Our Eyes - Lasik Protest In DC on 13 April 2018 also highlights the devastation LASIK and PRK can cause. 

Who is at risk of getting severe dry eyes after LASIK/PRK?
1. If you have an abnormal meibography, do not get LASIK/PRK. Be sure to ask for a meibography before any refractive or cataract surgery. 
2. Autoimmune disease: if you have an underlying autoimmune disease, you are more at risk. Autoimmune disease should be a contraindication for LASIK/PRK. 
3. History of Accutane: As Accutane can destroy meibomian glands, be sure you have normal meibomian glands before having any refractive surgery. My recommendation is to not have LASIK/PRK anyway unless really need it for work and especially to avoid if you had Accutane in the past.
4. Computer programmers or people who use electronic screens more than 4-6hrs per day. My hypothesis is that people do not blink as often on screens (this is known but its conclusion has not been proven yet), which leads to less milking of the meibomian oil gland, which leads to an abnormal tear film and possible chronic dry eye. If you are a computer programmer, do not get LASIK/PRK.
5. Other risk for getting visual aberrations after LASIK/PRK:
- large pupils; thin corneas, 
-abnormally shaped corneas or other corneal abnormalities or scarring; 
-high degrees of astigmatism; 
-severe dry eye; and possibly people who have other 
-patients who have other sensitivities, pain syndromes or neurological disorders, frequent headaches or anxiety and depression.



Detailed Risks after LASIK/PRK:
1. Approximately 700,000 LASIK cases were performed in 2017, up from 628,724 in 2016, according to Market Scope, a market research company that focuses on the ophthalmic industry.

2. Both acute and long–term ocular pain and discomfort following LASIK have been reported [,,]. It is suggested that almost all patients have at least mild symptoms after their procedure and that 20-55% of patients have persistent symptoms, defined as symptoms at 6 months or more post-procedure 

3. Researchers at Ohio State University analyzed clinical data submitted to the F.D.A. by Lasik system manufacturers. The researchers reported in 2007 that while most of the roughly 4,500 patients had achieved 20/20 or 20/40 vision six months after the procedure, 20 percent had dry eyes that were severe or worse than before surgery.

4. 20 percent and 55 percent of Lasik patients have persistent dry eyes, defined as lasting at least six months after surgery (reference below: Galor et.al.).



Incidence of chronic dry eye symptoms after refractive surgery
StudyProcedureNDesignDefinitionIncidence
Denoyer 2014 []LASIK60Prospective seriesUse of eye drops at 6 months43%
De Paiva 2006 []LASIK35Prospective randomized (nasal vs. superior hinge)Fluorescein staining score of 3 or more at 6 months36.4% (overall)
Shoja 2007 []LASIK95Retrospective seriesSubjective symptoms at 6 months20%
Donnenfeld 2003 []LASIK52Prospective randomized (nasal vs. superior hinge)Patients reporting eyes drier than before LASIK at 6 months31% (overall)
Tuisku 2007 []LASIK20 casesRetrospective case-controlSubjective symptoms at 2 - 5
years
55%
Hovanesian 2001 []LASIK and PRK781Mailed questionnaireSubjective symptoms at 6 months or more44%
https://www.ncbi.nlm.nih.gov/pubmed/25896684


Treatment Options:

There are many treatment options for Dry Eye Symptoms in general and particularly after LASIK. Some surgeons routinely place punctal plugs before LASIK is done or shortly thereafter. 


These plugs are made out of silicone or collagen and can be temporary, absorbable, or "semi-permanent": meaning the stay in long term unless removed or pop out.


Some surgeons start patients on Restasis, Xiidra, and/or Autologous Serum right after LASIK if dryness is very bad.


Here is the link of all the dry eye treatments available to date:
http://eyedoc2020.blogspot.com/2018/05/step-ladder-2018-almost-all-treatments.html

Here is more information below.
SLC



 2018 Jun 8:1-7. doi: 10.1159/000487951. [Epub ahead of print]

Plasma Rich in Growth Factors for the Treatment of Dry Eye after LASIK Surgery.

Author information

1
Fundación de Investigación Oftalmológica, Instituto Universitario Fernández-Vega, Oviedo, Spain.
2
University Institute for Regenerative Medicine and Oral Implantology - UIRMI (UPV/EHU-Fundación Eduardo Anitua), Vitoria, Spain.
3
Biotechnology Institute (BTI), Vitoria, Spain.
4
Laboratory of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of the Basque Country, Vitoria, Spain.
5
Networking Biomedical Research Center on Bioengineering, Biomaterials and Nanomedicine, CIBER-BBN, SLFPB-EHU, Vitoria, Spain.

Abstract

PURPOSE:

The aim of this study was to evaluate the use of plasma rich in growth factors (PRGF) eye drops in patients with dry eye disease after laser-assisted in situ keratomileusis (LASIK) surgery.

MATERIAL AND METHODS:

This is a longitudinal, retrospective, comparative, and descriptive study of 77 eyes of 42 patients with dry eyedisease following LASIK surgery. This study was designed to evaluate the efficacy of PRGF treatment compared to conventional therapy (control group). Outcome measures including signs and symptoms of dry eye disease were evaluated before and after treatment. The percentage of change before and after treatment for each clinical variable measured was compared between both groups.

RESULTS:

There were 1-4 treatment cycles with PRGF eye drops (1 cycle = 6 weeks). Results showed a statistically significant improvement in the Ocular Surface Disease Index (38.12%), visual analogue scale scores for frequency (41.89%) and severity (42.47%), and the Schirmer test scores (88.98%) after PRGF treatment (p < 0.05). No adverse events were reported after PRGF treatment.

CONCLUSIONS:

These results suggest that PRGF eye drops are effective for the improvement of dry eye symptoms in patients who underwent LASIK surgery in comparison to the conventional therapy. The treatment with PRGF is an alternative for patients who suffer from postoperative dry eye.

References:
1. Raoof D, Pineda R. Dry eye after laser in-situ keratomileusis. Semin Ophthalmol. 2014;29(5–6):358–362. [PubMed]
2. Solomon KD, Holzer MP, Sandoval HP, et al. Refractive surgery survey 2001. J Cataract Refract Surg. 2002;28(2):346–355. [PubMed]
3. Shoja MR, Besharati MR. Dry eye after LASIK for myopia: incidence and risk factors. Eur J Ophthalmol. 2007;17(1):1–6. [PubMed]
4. Chao C, Golebiowski B, Stapleton F. The role of corneal innervation in LASIK-induced neuropathic dry eye. Ocul Surf. 2014;12(1):32–45.

 2015 Apr 21;11:21. doi: 10.1186/s12990-015-0020-7.

Chronic dry eye symptoms after LASIK: parallels and lessons to be learned from other persistent post-operative pain disorders.

Author information

1
Bascom Palmer Eye Institute, University of Miami, 900 NW 17th Street, Miami, FL, 33136, USA. alevitt@med.miami.edu.
2
Bascom Palmer Eye Institute, University of Miami, 900 NW 17th Street, Miami, FL, 33136, USA. agalor@med.miami.edu.
3
Miami Veterans Administration Medical Center, 1201 NW 16th St, Miami, FL, 33125, USA. agalor@med.miami.edu.
4
Departments of Ophthalmology, Pathology and Pharmacology, Louisiana State University Health Sciences Center, Louisiana State University Eye Center, New Orleans, LA, USA. jweiss@lsuhsc.edu.
5
Miami Veterans Administration Medical Center, 1201 NW 16th St, Miami, FL, 33125, USA. EFelix@med.miami.edu.
6
Department of Physical Medicine and Rehabilitation, University of Miami Miller School of Medicine, Miami, FL, USA. EFelix@med.miami.edu.
7
John P. Hussman Institute for Human Genomics, University of Miami Miller School of Medicine, Miami, FL, USA. EMartin1@med.miami.edu.
8
John T Macdonald Foundation Department of Human Genetics, University of Miami Miller School of Medicine, Miami, FL, USA. EMartin1@med.miami.edu.
9
Department of Anesthesiology, Perioperative Medicine and Pain Management, University of Miami Miller School of Medicine, Miami, FL, USA. dpatin@med.miami.edu.
10
Department of Anesthesiology, Perioperative Medicine and Pain Management, University of Miami Miller School of Medicine, Miami, FL, USA. KSarantopoulos@med.miami.edu.
11
Miami Veterans Administration Medical Center, 1201 NW 16th St, Miami, FL, 33125, USA. RLevitt@med.miami.edu.
12
John P. Hussman Institute for Human Genomics, University of Miami Miller School of Medicine, Miami, FL, USA. RLevitt@med.miami.edu.
13
John T Macdonald Foundation Department of Human Genetics, University of Miami Miller School of Medicine, Miami, FL, USA. RLevitt@med.miami.edu.
14
Department of Anesthesiology, Perioperative Medicine and Pain Management, University of Miami Miller School of Medicine, Miami, FL, USA. RLevitt@med.miami.edu.

Abstract

Laser in-situ keratomileusis (LASIK) is a commonly performed surgical procedure used to correct refractive error. LASIK surgery involves cutting a corneal flap and ablating the stroma underneath, with known damage to corneal nerves. Despite this, the epidemiology of persistent pain and other long-term outcomes after LASIK surgery are not well understood. Available data suggest that approximately 20-55% of patients report persistent eye symptoms (generally regarded as at least 6 months post-operation) after LASIK surgery. While it was initially believed that these symptoms were caused by ocular surface dryness, and referred to as "dry eye," it is now increasingly understood that corneal nerve damage produced by LASIK surgery resembles the pathologic neuroplasticity associated with other forms of persistent post-operative pain. In susceptible patients, these neuropathological changes, including peripheral sensitization, central sensitization, and altered descending modulation, may underlie certain persistent dry eye symptoms after LASIK surgery. This review will focus on the known epidemiology of symptoms after LASIK and discuss mechanisms of persistent post-op pain due to nerve injury that may be relevant to these patients. Potential preventative and treatment options based on approaches used for other forms of persistent post-op pain and their application to LASIK patients are also discussed. Finally, the concept of genetic susceptibility to post-LASIK ocular surface pain is presented

More References:
Hi everyone,

This upcoming Friday (4/13), a protest against Lasik will be taking place. Please see details below and let me know if you can make it. We will meet at the convention center at 10:00am.

LASIK COMPLICATIONS FACEBOOK GROUP
PROTEST AGAINST LASIK EYE SURGERY

We are protesting a meeting of LASIK eye surgeons, which is taking place at the Walter E. Washington Convention Center in Washington DC on April 13, 2018.

The principle of non-maleficence – “First, do no harm” -- requires that LASIK not be performed because LASIK drastically harms a minority, and drives some people suicidal.

LASIK surgeons have publicly denied any link between LASIK complications and suicide, despite more than a dozen known cases of LASIK-related suicide and countless anecdotal reports of LASIK-related thoughts of suicide.

LASIK surgeons refuse to accept responsibility for the needless harm that they have inflicted upon a substantial number of their patients. They deliberately hide bad LASIK outcomes resulting in suicide, blindness, loss of eye, corneal transplant, reduced vision, and other serious, life-altering complications.

FDA-approval of LASIK was a mistake. Morris Waxler, PhD, is a former FDA official who has turned whistle-blower against LASIK and is calling for the FDA to withdraw approval of LASIK devices. He says that the agency was pressured by powerful ophthalmologists to disregard surgically-induced problems, and asserts data-tampering by LASIK surgeon-investigators.

Vision is responsible for 80 percent of the information that the human brain receives. Performing LASIK is playing Russian roulette with patients’ eyes and with their lives.

LASIK is medical fraud. The surgery has become a leading cause of preventable vision loss.

LASIK surgeons do not fully disclose potentially life-altering risks of the surgery, such as intractable dry eyes, corneal neuropathic pain, night vision problems, and corneal biomechanical failure (ectasia). LASIK surgeons do not inform prospective patients of long-term consequences of LASIK, including a permanent corneal flap that may be accidentally dislodged for life. LASIK exposes patients to delayed complications months or years after the surgery.

The FDA is aware of widespread problems with LASIK, but is complicit in keeping the general public in the dark.

LASIK surgeons engage in false advertising and hard-sell tactics while hiding the risks and consequences of the surgery. They behave more like used car salesmen than medical doctors. Deceptive and misleading LASIK ads that fail to disclose risks are illegal, but LASIK surgeons ignore the law and advertise with seeming impunity. The FDA has the power to punish false advertisers of LASIK, but the agency does nothing.

LASIK providers routinely ignore FDA law, which requires that LASIK complications be reported to the laser manufacturer or to the FDA. The FDA has full knowledge of widespread non-compliance but looks the other way.

LASIK surgeons use short-term “satisfaction” rates as a smokescreen to hide the high rate of “side effects” and complications.

LASIK surgeons refuse to acknowledge that patients have been harmed. Instead, LASIK surgeons label patients with complications as simply “dissatisfied.”

There is a huge disconnect between eye surgeons who perform LASIK and the LASIK patient population regarding what constitutes a LASIK complication. What a patient considers a bad outcome is often dismissed as a minor “side effect” by the surgeon who performed the procedure.

The FDA’s latest study of LASIK, completed in 2014, found the following alarming rates of problems with the procedure (3 months post-LASIK):

• Up to 46% of subjects who were symptom-free before LASIK reported visual symptoms (halos, starbursts, glare, and ghosting) after LASIK.
• Up to 28% of subjects with no symptoms of dry eyes before LASIK developed dry eye symptoms after LASIK.

A Consumer Reports survey found that 53% of laser eye surgery patients experience at least one side effect and 22% still have problems six months after surgery. This is consistent with data from 12 LASIK clinical trials, which show that approximately 20 percent of patients report dry eyes, glare, halos, and night driving problems six months after LASIK.

LASIK leaves all eyes with permanent pathology, even in the absence of any immediately obvious complications. Researchers report the following consequences of LASIK in 100% of eyes treated:

• The corneal flap never fully heals, exposing patients to life-long risk of traumatic flap dislocation and increased risk of eye infection.
• Biomechanical strength of the cornea is reduced after LASIK, which may lead to sight-threatening corneal ectasia months or years after surgery.
• Intraocular pressure measurements are falsely low after LASIK, leading to possibility of vision loss from undiagnosed glaucoma.
• LASIK causes error in calculation of lens power for cataract surgery, exposing patients to poor vision after cataract extraction.
• Corneal nerves that stimulate tear production are severed and destroyed during LASIK, and these nerves may never fully recover normal densities and patterns -- potentially leading to intractable dry eye disease and/or persistent corneal neuropathic pain. LASIK-induced corneal neuropathic pain may be incapacitating and provoke thoughts of suicide.

Osman et al. (2017) found that LASIK using the latest blade-free technology leads to posterior vitreous detachment (floaters) in 85% of eyes.

Visual quality at night is routinely reduced after LASIK – permanently. LASIK patients with night vision problems are a hazard to themselves and others who share the roadways with them at night.

Studies have found that LASIK patients undergo cataract surgery up to 15 years earlier – and have worse outcomes – than people who have not had LASIK.

LASIK surgeons misinform prospective patients about need for reading glasses. Nearsighted patients who avoid LASIK can read without glasses after age 40. To add insult to injury, visual outcomes of LASIK decline over time. Most LASIK patients will be back in glasses, sometimes sooner rather than later.

LASIK surgeons tout LASIK “satisfaction” rates to distract from the high rate of side effects, complications, and long-term consequences of the surgery. They want you to believe that 20/20 is good vision, which is not true in every case. 20/20 vision may be highly distorted after LASIK.

Some people will argue that “all surgery has risk.” That is a weak, rhetorical defense. A certain degree of risk is acceptable when the surgery is medically necessary. Because LASIK is unnecessary and performed on a healthy eye, the acceptable complication rate should be virtually zero. LASIK is not medicine, it’s Big Business. Buyer beware!
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