LASIK-Flap

Uncovering secrets of the laser eye surgery industry

The LASIK Report

A Call for the Discontinuation of a Harmful Procedure
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 Post subject: What patients should know about the LASIK flap pre-surgery
PostPosted: Thu May 11, 2006 6:31 pm 
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What patients should know about the LASIK flap:


The problem with statistics for LASIK complications is that nobody is really keeping track of them! Damage to the flap can occur during surgery or as a result of injury - but accurate records of the incidence of flap complications do not exist.

Patients who lose their flap entirely have a serious problem. If the flap dries out it's a problem. Visual outcome probably depends on the condition of the flap (was it torn, ripped entirely off, or just rumpled), the amount of time it takes to get some medical help, and the skill of the doctor who attempts to address the situation.

- Dr. Gary Tylock lost a patient's flap and was sued as a result:
http://www.lasiksucks4u.com/media/litpdfs/Dockery%20v.%20Tylock.pdf

- One of the website operators has videos of two surgeries where the flap was lost DURING SURGERY, and has stated he will post the videos on his site.

- A veterinarian from Wyoming had his flap fall off in his lap when he was driving home from surgery.

There is a thread about the flap not healing and traumatic flap displacement on Thelasikflap - http://thelasikflap.com/forum/viewtopic.php?t=21. Some of the articles on traumatic flap dehiscence from PubMed are posted there.

LASIK flap basics:

All LASIK patients should know that they will have a LASIK interface for life, and that their flap can be easily lifted by a doctor with a simple tool or dislodged accidentally by a child's finger poke, a tree branch, a sports injury etc. Patients should know that creation of the lasik flap reduces by about a third the mechanical strength of the cornea, because the flap does not contribute to corneal stability.

Patients should know that all LASIK patients' eyes are bulging forward.

LASIK patients should know that microstriae are a universal occurrence after LASIK, and that debris under the flap including metal debris from the microkeratome is very common if not universal.

Patients should know that there is a possiblity of inflammation/infection in the interface even years after surgery.

Patients should know that creation of the LASIK flap severs corneal nerves resulting in dry eye, and that the FDA warns that dry eye may be permanent.

Patients should know that the mere cutting and creation of the flap with no lasering induces higher order aberrations.

Patients should know that flap healing may be irregular and that this may compromise vision.


Last edited by Scientist on Mon Jul 23, 2007 6:41 am, edited 2 times in total.

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 Post subject: Re: What patients should know about the LASIK flap pre-surge
PostPosted: Fri May 12, 2006 5:55 am 
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Scientist wrote:
Patients should know that creation of the lasik flap reduces by about a third the mechanical strength of the cornea,


I've read that the anterior cornea is actually stronger than the deeper layers, which would mean that the loss of integrity after a flap is cut is greater than 1/3 (the flap is about 1/3 of the thickness of the cornea). This refers to the strength to withstand the constant outward force of the natural intraocular pressure. If the cornea is too weak, it begins to bulge forward and can result in permanent vision loss, similar to what happens in a keratoconus eye -- see diagram at:
http://www.aoa.org/x4721.xml

Regarding strength to withstand a flap dislocation, medical research shows that the flap itself has only 2.4% of the tensile strength of normal cornea and the flap edges (where the scar forms) is only 28% as strong as a normal cornea.

http://www.ncbi.nlm.nih.gov/entrez/quer ... t=Abstract

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PostPosted: Sat May 13, 2006 7:30 pm 
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J Refract Surg. 2005 Mar-Apr;21(2):186-90.

Biomechanical modeling of corneal ectasia.

Dupps WJ Jr.

Quote:
In the elastic thin shell assumption, the cornea is
treated as a structurally and mechanically homogeneous
entity. But many clues to the etiology of keratectasia
after LASIK might be gleaned from regional differences
in the cellular and extracellular constituents
of the stroma. In addition to the volume-loss related
elastic factors reviewed by Guirao, certain inhomogeneities
may contribute to the increased frequency of
ectasia in LASIK compared to surface ablation. The
posterior stroma is particularly vulnerable in LASIK
due to altered proteoglycan composition, fewer collagen
crosslinks, and reduced keratocyte density
. The
first two factors may predispose the posterior cornea to
excessive elastic and viscoelastic strain, and the third
may have implications in altered stromal remodeling
and late keratectasia.

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 Post subject:
PostPosted: Sat May 13, 2006 7:53 pm 
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http://bjo.bmjjournals.com/cgi/content/full/85/4/437

Quote:
Contrary to the orthogonally arranged lamellae in the mid and posterior stroma, the collagen bundles in the anterior stroma are undulating and interwoven.11-13 Such differences in organisation may cause different cohesive strengths between collagen bundles in the anterior and posterior stroma and may account, for instance, for the easy separation of the collagen lamellae in the posterior stroma.


Quote:
LASIK studies do not report flaps of less than 160 µm, which means that the flap always includes the most stable part of the cornea and is connected at the temporal side of the cornea by a small hinge. In a histological study in humans in which LASIK was performed before enucleation of one eye it was demonstrated that mainly fibronectin and tenascin were formed at the border between flap and stroma. These adhesive glycoproteins are present between epithelium and Bowman's layer and can easily be disrupted to perform additional laser treatments. There is no need to wonder why various patients suffer from wrinkles within the flap and epithelial ingrowth.


Quote:
PRK is different from LASIK because a great part of the most anterior stroma is ablated. Bowman's layer does not recover and irregularities on the surface are compensated by ingrowth of epithelial cells (personal observation). Interference with the most tightly interwoven part of the cornea may result in visual problems. A significant proportion of treated patients may show refractive regression, haze, or astigmatism after both types of treatment. Astigmatism is a clinical complication related to irregularities in the corneal curvature. Formation of these irregularities may be due to a reduction in cohesiveness of the collagen bundles in the central corneal stroma. Our results indicate that the most rigid part of the stroma is ablated (PRK) or intersected (LASIK), thus weakening the stability of the cornea. This emphasises that people who underwent refractive surgery may have an increased risk of optical problems.

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 Post subject:
PostPosted: Mon May 22, 2006 9:34 pm 
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Quote:
Our results indicate that the most rigid part of the stroma is ablated (PRK) or intersected (LASIK), thus weakening the stability of the cornea. This emphasises that people who underwent refractive surgery may have an increased risk of optical problems.


And to think these surgeries are marketed to IMPROVE your vision! And are performed on healthy virgin eyes by 'DOCTORS', who by this time have been to enough meetings, induced enough visual trash in their own offices, and have read enough about the consequences of corneal refractive surgery in the top journals of their field to know that what they are doing is causing harm...

Yet they continue to slash and gash for cash.


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 Post subject:
PostPosted: Sat May 27, 2006 7:23 pm 
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Cornea
Volume 25(4), May 2006, pp 388-403
Corneal Ectasia After Laser In Situ Keratomileusis in Patients Without Apparent Preoperative Risk Factors

Excerpt:

The biomechanical strength of the posterior stroma is less than that of the
anterior stroma. Because the load-bearing function of the anterior stroma is disabled after keratotomy, only the weaker deep stroma is left to maintain corneal integrity
.

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PostPosted: Sat Jan 06, 2007 7:55 am 
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http://www.escrs.com/PUBLICATIONS/EUROT ... ealing.pdf

Eurotimes
January 2007

Corneal wound healing after laser surgery

Quote:
Increased severing of corneal lamellae Dr Jaycock noted that the likely cause of the increased biomechanical instability following LASIK compared to PRK was the increased number of collagen lamellae that
are severed
in the intrastromal procedure. Collagen lamellae are more densely interwoven in the superficial third of the stroma than in the deeper two thirds. In addition, X-ray diffraction studies indicate that collagen fibres cross perpendicularly in the centre and cross increasingly obliquely towards the periphery of the cornea. (Meek et al, Exp Eye Res;2004:78;503-512). Thus the cornea is stronger anteriorly than
posteriorly
and stronger peripherally than centrally. In a 6.0 dioptre PRK correction, approximately five million collagen fibres are severed, whereas for a corresponding LASIK procedure, 230 million fibres are
severed
, Dr Jaycock pointed out. “It is somewhat unfortunate that the standard microkeratome flap incision severs the cornea at the strongest part in both the antero-posterior and radial planes. PRK and LASIK clearly have very different postoperative implications for the structural integrity of the cornea,” Dr Jaycock added.

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 Post subject:
PostPosted: Sat Apr 28, 2007 4:17 pm 
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http://www.escrs.org/PUBLICATIONS/EUROT ... nsflap.pdf

Quote:
All the studies in the published literature tell us that the anterior one-third of the cornea is exceptionally strong. In this part, the collagen fibres are interwoven and it is very difficult to pull them apart. There is a lot of biomechanical strength there. The deeper two-thirds of the cornea, by contrast, are actually weak.


Quote:
Explaining the implications of this, Dr. Marshall said that when a 6 dioptre PRK or LASEK correction is carried out, around five million supporting collagen fibrils are severed. This increases 40-fold in a LASIK procedure to over 230 million collagen fibrils. He added that lowering the flap in a LASIK procedure will not restore the biomechanical integrity of the cornea.


Quote:
"We can see that with some of the early LASIK flap depths of around 140 to 160 microns we are taking between one quarter and one third of the strength of the cornea away. It doesn’t matter at what point you get wound healing – this tensile strength will never come back,” he said.

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PostPosted: Sat Jul 21, 2007 9:00 am 
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Anterior Segment OCT Analysis of Thin IntraLase Femtosecond Flaps

Journal of Refractive Surgery Vol. 23 No. 6 June 2007

Jason E. Stahl, MD; Daniel S. Durrie, MD; Frank J. Schwendeman, OD; Allen J. Boghossian, DO

Quote:
The importance of corneal biomechanics in refractive surgery outcomes has become apparent with recent publications.11,12 The corneal stroma consists of lamellae (organized collagen fibers), which run from limbus to limbus. Traditional LASIK, using a mechanical microkeratome, creates a fl ap approximately 160 μm thick, which severs a significant number of collagen fibers compared to PRK. The loss of lamellar integrity following LASIK results in compromised corneal biomechanical integrity due to minimal biomechanical loading distributed throughout the flap. Hence, there is no contribution from the flap to the biomechanical stability of the cornea.1 Cohesive tensile strength studies demonstrate that Bowman’s layer is the strongest structural component of the cornea followed by the anterior third of the corneal stroma.1,13 In fact, the peripheral anterior third of the corneal stroma is stronger than the paracentral and central anterior third.12 These findings are supported by morphologic studies that demonstrate more collagen lamellar interweaving and collagen lamellae orientations that were transverse to the anterior surface of the cornea.14-16 These studies suggest that a thin, uniform flap would leave more of the strong anterior stroma untouched, which should provide greater corneal biomechanical strength than the thicker traditional LASIK flap that severs more of these strong anterior fibers.


Quote:
In addition, we speculate that flaps made deep to this level (traditional LASIK), in the weaker posterior cornea where the lamellae lie more parallel and less compact, create weaker corneal biomechanics.

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PostPosted: Tue Aug 21, 2007 7:15 pm 
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J Cataract Refract Surg. 2003 Jun;29(6):1152-8.

Six-year follow-up of laser in situ keratomileusis for moderate and extreme myopia using a first-generation excimer laser and microkeratome.

Sekundo W, Bönicke K, Mattausch P, Wiegand W.
Department of Ophthalmology, Philipps-University Marburg, Germany. sekundo@med.uni-marburg.de

Quote:
In a recent experimental study, Müller and coauthors13 show that dermatan sulfate containing 100 to 120 μm of anterior corneal stroma provides a higher degree of rigidity and mechanical stability than posterior lamellae containing keratan sulfate. While in PRK and laser-assisted subepithelial keratectomy, Bowman‘s layer and the anterior stroma are removed according to the ablation diameter,14 a microkeratome cut weakens the anterior 130 to 180 μm of cornea over a diameter of up to 9.5 to 10.0 mm. Thereafter, a weaker posterior stromal part is ablated.

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PostPosted: Sat Oct 20, 2007 12:16 pm 
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http://www.pconsupersite.com/

OCULAR SURGERY NEWS 10/15/2007
Durrie: Corneal refractive surgery headed to the sub-Bowman layer

Quote:
John Marshall, a renowned expert on corneal biomechanics, has been exploring these concepts for years. His general concept is that as you look at the cornea, the stronger fibers in the cornea are in the anterior and the periphery.

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"What concerns me is that if the person informing the patient is themselves poorly or inaccurately informed then how on earth can consent ever be truly informed?" Dr. Sarah Smith


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PostPosted: Fri Jan 18, 2008 8:41 am 
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Journal of Refractive Surgery Volume 24 January 2008
Depth-dependent Cohesive Tensile Strength in Human Donor Corneas: Implications for Refractive Surgery
J. Bradley Randleman, MD; Daniel G. Dawson, MD; Hans E. Grossniklaus, MD; Bernard E. McCarey, PhD; Henry F. Edelhauser, PhD

Quote:
Although physiologic stress is borne uniformly throughout the normal unoperated corneal stroma,13 this study has demonstrated that cohesive tensile strength is not uniform throughout the central corneal stroma. Cohesive tensile strength is inversely correlated with stromal depth, and the anterior 40% of the corneal stroma has significantly greater cohesive tensile strength than the posterior 60% of the corneal stroma. Increased rigidity of the anterior third of the human cornea has been indirectly surmised over the past few decades by many authors.14-19 Anterior corneal curvature remains relatively constant within a wide range of intraocular pressures and stromal hydration levels. Direct measurements of the biomechanical properties of human corneas, utilizing longitudinal tensile strength using strip testing and infl ation tests, are also consistent with these cohesive tensile strength results.9-11 Seiler et al11 showed that removing Bowman’s layer with the excimer laser reduced Young’s modulus by 4.75%. Kohlhaas et al10 found that the anterior stroma (200 μm) was 2.8-fold more rigid than the remaining posterior stroma (300 μm) at 5% strain. Jue and Maurice9 showed that Descemet’s membrane had a Young’s modulus of 0.5 MPa at physiologic stress levels, which is considerably less than that of corneal stroma. The results of this study combined with the aforementioned work have potential implications for excimer laser corneal refractive surgery. The cornea is the load-bearing front wall of the eye, responsible for withstanding normal physiologic intraocular pressures as well as acute increases of intraocular pressure in situations such as eye rubbing or Valsalva maneuver, and thereby resisting permanent alterations in corneal curvature. When the cornea loses this normal tectonic integrity ectasia develops, either in naturally occurring ectatic processes such as keratoconus or pellucid marginal corneal degeneration, or postoperatively after excimer laser ablation.

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PostPosted: Thu Mar 06, 2008 8:08 pm 
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http://www.osnsupersite.com/view.asp?rID=26812

Quote:
“The structure of the anterior third of the cornea is different to that in the posterior two-thirds of the corneal stroma,” he said. “In the anterior third, fibers are more densely packed and more densely interwoven than they are in the posterior two-thirds.”

The cohesive tensile strength of the anterior third of the cornea is about twice that of the posterior two-thirds, Dr. Knox Cartwright said. In clinical practice, any incision in the anterior stroma may adversely affect structural strength.


Based on this information, making a corneal flap that is 1/3 the thickness of the cornea reduces the biomechanical strength of the cornea by approximately 50%. This is confirmed by the following:

http://www.osnsupersite.com/view.asp?rID=26470

Quote:
"At 6 months postoperatively, the LASIK eyes experienced a 48% reduction in corneal biomechanics, while the eyes that underwent surface ablation had only a decrease between 10% and 14%," Dr. Cazal said.

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PostPosted: Wed Apr 09, 2008 6:02 pm 
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J Refract Surg. 2008 Jan;24(1):S85-9.

Depth-dependent cohesive tensile strength in human donor corneas: implications for refractive surgery.

Randleman JB, Dawson DG, Grossniklaus HE, McCarey BE, Edelhauser HF.
Emory University, Department of Ophthalmology, Atlanta, GA, USA. Jrandle@emory.edu

PURPOSE: To determine the cohesive tensile strength throughout the stroma of normal human donor corneas and evaluate the relevance of these findings within the context of current excimer laser surgical techniques.

METHODS: Twenty normal corneoscleral buttons from 11 donors were obtained from the Georgia Eye Bank. The corneas were cut into 3-mm strips, dissected at varying stromal depths, mechanically separated through the dissection plane using a motorized extensometer, and measured for cohesive tensile strength. Central corneal thickness and dissection depth were measured by routine light microscopy and correlated with cohesive tensile strength measurements. RESULTS: A strong negative correlation was noted between stromal depth and cohesive tensile strength (r = -0.93). The anterior corneal stroma directly adjacent to Bowman's layer followed by the underlying anterior 40% of the corneal stroma had the highest cohesive tensile strength. Cohesive tensile strength plateaued from 40% to 90% corneal stromal depth and then declined rapidly from the posterior 10% of the stroma to Descemet's membrane. The anterior 40% of the corneal stroma had significantly higher cohesive tensile strength than the posterior 60% (33.3 g/mm vs 19.6 g/mm, P < .00001). Within the central 40% to 60% depth, a positive correlation was found between increased age and increased tensile strength (r = 0.67), with corneal tensile strength increasing 38% from ages 20 to 78 years.

CONCLUSIONS: The anterior 40% of the central corneal stroma is the strongest region of the cornea, whereas the posterior 60% of the stroma is at least 50% weaker. The risk for ectasia may therefore be greater with ablations into the posterior stroma. Increasing age is associated with increased corneal cohesive tensile strength.

From the full text:

Quote:
Excimer laser corneal refractive surgery inevitably reduces keratocyte density and corneal tensile strength. Although both surface ablation techniques and LASIK reduce overall tensile strength through tissue removal, LASIK further weakens the cornea through lamellar flap creation because the anterior lamellar flap does not contribute significantly to postoperative corneal tensile strength.


Quote:
As these results demonstrate, excimer laser ablation reduces not only the quantity of the remaining load-bearing corneal tissue, but also the quality of the residual load-bearing corneal tissue (measured as reduced cohesive tensile strength), especially when laser ablation extends deeper than the anterior 40% of the corneal stroma. Ablation beyond this anterior 40% rarely occurs with surface ablation procedures; however, standard LASIK more frequently extends into the posterior 60% of the stroma through a combination of laser ablation and flap creation with average thicknesses of approximately 150 μm that can be highly variable. These findings agree with reported ectasia studies, where more than 90% of reported corneal ectasia cases have occurred after standard LASIK.


Quote:
Cohesive tensile strength studies in human donor corneas demonstrate that the anterior 40% of the central corneal stroma has the highest cohesive tensile strength, whereas the tensile strength in the posterior 60% of the cornea is approximately 50% less. Cohesive corneal tensile strength increases with age. Based on these results, the maximal amount of anterior stroma should be left intact to maximize postoperative corneal integrity.

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PostPosted: Sun Aug 23, 2009 7:54 pm 
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Jory W. Corneal ectasia after LASIK. J Refract Surg. 2004 May-Jun;20(3):286.

To the Editor:

Excerpts:

Quote:
The corneal flap of approximately 160 μm, of one third thickness of the average cornea, has been shown to never heal fully by Seiler and Marshall (personal communication, June 26, 2000). Approximately 22 million corneal fibers are intersected, their severed ends never rejoining, meaning that the flap is held in place only by glycosaminoglycans and peripheral scar tissue. To put it more simply, the corneal flap after LASIK provides no more corneal strength than the wearing of a contact lens.


Quote:
Simple mathematics tell us that with a flap of 160 μm and an average corneal thickness of 550 μm, the cornea is weakened by 38% in a -4.00-D correction and 51% in a -7.00-D correction. Furthermore, the corneal weakening, which occurs in every eye after LASIK, is probably even more severe. Bron demonstrated that the anterior 100 to 200 μm of the cornea (included in the LASIK flap) have the greatest strength, and Muller showed that the anterior cornea has the greatest stability. Park reported that the deeper cornea has less biomechanical strength than the anterior cornea, and Amoils found keratoconus-like topography in healthy LASIK corneas after minimal ablations of as little as 37 μm.

Aware of the danger of ectasia after LASIK, the American Society of Cataract and Refractive Surgery is polling its entire membership to report this (Marshall J. ASCRS, Port Dolovas, 2003), and Pallikaris—a LASIK pioneer—is switching to epi-LASIK, avoiding biomechanical problems after LASIK.

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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