LASIK in Patients with Collagen Vascular Disease
When photorefractive keratectomy (PRK) was initially approved by the United States Food and Drug Administration, it established a list of both ocular and systemic absolute and relative contraindications to refractive surgery. Included on the list of systemic relative contraindications are autoimmune and connective tissue disorders, including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), Sjogren’s syndrome, and a number of the spondyloarthropathies. As there was a paucity of data on the outcome of refractive laser surgery in these patients, the recommendations were based on theoretical risk and non-laser ocular surgery outcomes in the same patient population.
The contraindication has not evolved since LASIK became the refractive procedure of choice, and in 2002, The American Academy of Ophthalmologists issued its LASIK guidelines, echoing the US FDA with regards to the exclusion of autoimmune/collagen vascular diseases,.
Recently, several studies have attempted to clarify precisely which autoimmune and collagen vascular diseases, if any, predispose the patient to a higher risk of complications and adverse events.
Rationale for Exclusion
When the US FDA issued their initial guidelines, the justification for excluding autoimmune collagen vascular diseases was a fear of a number of potential complications, including 1) an increased postoperative inflammatory response 2) a deranged healing response that could ultimately damage the corneal tissue and 3) the thought that surgery could trigger an underlying predisposition for corneal melting and scarring.
There was also some concern that patients with collagen vascular diseases are generally on an immunosuppressive drug regimen to control their disease, and systemic immunosuppression is itself a relative contraindication to refractive laser surgery, due to increased infection risk.
Additionally, as many collagen vascular diseases have some ocular involvement, which was seen as a third reason to exclude this patient population.
Ocular Pathology in Collagen Vascular Disease
Many systemic collagen vascular diseases have ocular manifestations
The most common ocular pathology in RA is keratoconjunctivitis sicca (KCS), which occurs in 15-25% of RA patients. KCS in RA patients often present as secondary Sjogren’s syndrome, which in addition to KCS, includes xerostomia, a positive salivary glad biopsy and serologic evidence of autoantibodies. Less common than KCS, RA patients can experience significant corneal inflammation and anterior scleritis, the reported incidence of scleritis in RA patients is between 0.7-6.3%. Additionally, inadequate tear formation in RA patients can predispose to ocular infection.
Systemic Lupus Erythematosus
As with RA, the most common ocular pathology in patients with SLE is KCS, which can also present as secondary Sjogren’s syndrome, although this is less common than in RA. Rarely, patients with SLE can experience retinal vasculitis, episcleritis, or anterior uveitis. Multiple ocular complaints SLE patients is considered a marker for poor disease control and rapid progression.
When Sjogren’s syndrome occurs in patients without associated collagen vascular disease, it is termed primary Sjogren’s syndrome. These patients experience the same ocular complaints as patients suffering from secondary Sjogren’s syndrome due to collagen vascular disease (see above under "Rheumatoid Arthritis").
Inflammation, generally in the form of uveitis, is the most common ocular symptom among all the spondyloarthropathies, which include psoriatic arthritis, ankylosing spondylitis, and reactive arthritis (formerly Reiter’s syndrome). Between 20-40% of patients will develop anterior uveitis at some point during their disease course.
LASIK-Induced Neutrophilic Epitheliopathy
It is well documented that LASIK can cause iatrogenic dry-eye syndrome. This outcome may be exaggerated in patients with pre-existing dry eyes, as seen in the collagen vascular diseases discussed earlier,.
For years, the only data supporting or refuting US FDA and AAO guidelines regarding autoimmune/collagen vascular disease were sporadic case reports, or studies detailing complications in these patients while performing other ocular surgeries, usually cataract/lens surgery.
In the past decade, more researchers have started to examine whether these recommendations can be supported through data.
Rheumatoid Arthritis in Non-Laser Ocular Surgery
Ocular surgery has been shown to lead to complications in RA patients. There are multiple case reports in the literature detailing significant post-operative complications in RA patients following cataract and lens surgery, including sterile corneal ulceration, necrotizing scleritis and corneal melting,,. Most of the patients who experienced these complications had a previously documented history of sicca syndrome,,,.
Rheumatoid Arthritis and LASIK
There is one case report in the literature of peripheral keratitis in an RA patient following LASIK however, there are several small (50 total eyes) retrospective studies of LASIK in patients with RA which all found no incidence of any serious complications or corneal haze in the year following surgery,,.
There is one published study that may contract these findings. It reported corneal melting in 12 patients 2-5 weeks after LASIK; of these patients, 5 had an unspecified autoimmune disease. The study did not detail whether or not their disease was well controlled at the time of surgery. Interpretation of the study was also complicated by reports of epithelial ingrowth in the post-operative period, making it unclear if the complications resulted from systemic disease or from untreated epithelial ingrowth.
Systemic Lupus Erythematosus
Systemic Lupus Erythematosus and PRK
There are only two case reports that associate SLE with significant post-operative corneal complications, both occurring after photorefractive keratectomy. In one case, a patient with active SLE developed severe ulceration with perforation in the immediate post-operative period. In the second case, a previously healthy patient developed corneal scarring requiring debridement several years after PRK, at which time she was diagnosed with SLE.
Systemic Lupus Erythematosus and LASIK
Three small (50 total eyes) retrospective studies evaluated post-LASIK complications in patients with well-controlled SLE. There was no reported incidence of serious postoperative complications or corneal haze in any of the studies,,. Additionally, there was no observed incidence of disease reactivation in at least one of the studies.
There is one published study that may contract these findings, which is the same study detailed above (See RA and LASIK).
There is no data that looks at post-ocular surgical complications in patients with primary Sjogren’s syndrome. The data that does exist regarding Sjogren’s syndrome examines it within the context of other collagen vascular diseases, specifically RA.
There is one published case studies detailing late-onset severe diffuse lamellar keratitis and uveitis in a patient with ankylosing spondylitis after LASIK.
In three small, retrospective studies (23 total eyes) there were no reported incidences of serious postoperative complications or corneal haze,.
LASIK-Induced Neutrophilic Epitheliopathy
Of the three retrospective studies referenced, two did not evaluate the incidence or severity of LASIK-induced neutrophilic epitheliopathy,. The third study found that post-operative tear break-up times (TBUT) were shorter than expected, but returned to normal by the third post-operative month. This study also found 16% of patients experienced exaggerated dry-eye symptoms requiring frequent use of drops until the sixth post-operative month, but only 4% had dry eye symptoms persisting beyond that time.
Corticosteroid Use and LASIK
One study (29 patients, 56 eyes) looked specifically at patients with collagen vascular disease on systemic immunosuppressive therapy. It found no incidence of postoperative infection or impaired would healing.
Despite an increase in literature focusing on post-LASIK outcomes in patients with collagen vascular diseases, there is still relatively little available data to help guide practitioners. Most of the research seems to indicate that in a number of cases, LASIK can be performed safely and with a satisfactory outcome in patients with collagen vascular disease,,; however more research will be needed to alter the US FDA or AAO recommendations.
Proposed exceptions to current guidelines
Given the research above, it seems reasonable to consider some exceptions to the US FDA and AAO guidelines listing collagen vascular disease as a relative contraindication to LASIK surgery.
Systemic and Ocular Involvement
Research seems to indicate that in patients with well controlled systemic and/or ocular symptoms, who are 6 months removed from any flare of symptoms, LASIK can be performed safely and with a satisfactory outcome,,.
Research supported that patients on low, maintenance dose of systemic corticosteroids can receive LASIK without an increased risk of postoperative complications. Patients on a high dose burst of steroids, or who have completed a high-dose steroid taper within the past six months for a flare treatment should be excluded from consideration.
- ↑ 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 1.10 1.11 Cobo-Soriano R, Beltran J, Baviera J. Ophthalmology 2006; 113:1118.e1 – 1118.e8
- ↑ 2.0 2.1 2.2 2.3 2.4 2.5 2.6 Smith RJ, Maloney RK. Laser in situ keratomileusis in patients with autoimmune diseases. J Cataract Refract Surg 2006; 32:1292-1295
- ↑ US FDA website. When is LASIK not for me? Available at http://www.fda.gov/medicaldevices/productsandmedicalprocedures/surgeryandlifesupport/lasik/ucm061366.htm. Accessed May 11, 2012.
- ↑ Thompson AU, Eadie S. Keratoconjunctivitis sicca and rheumatoid arthritis. Ann Rheum Dis 1956; 15:21
- ↑ Omerod LD, Fong LP, Foster CS. Corneal infection in mucosal scarring disorders and Sjogren’s syndrome. Am J Ophthalmol 1988; 15(5):512
- ↑ Theander E, Jacobson LT. Relationship of Sjogren’s syndrome to other connective tissue and autoimmune disorders. Rheum Dis Clin North Am 2008; 34:935
- ↑ Nguyen QD, Foster CS. Systemic lupus erythematosus and the eye. Int Ophthalmol Clin 1998; 38:33-60
- ↑ Ramos-Casals M, Tzioufas AG, Font J. Primary Sjogren’s syndrome: new clinical and therapeutic concepts. Ann Rheum Dis 2005; 64:347
- ↑ Rosenbaum JT. Acute anterior uveitis and spondyloarthropathies. Rheum Dis Clin North Am 1992; 18:143
- ↑ 10.0 10.1 Wilson SE. Laser in situ keratomileusis-induced (presumed) neutrophilic epitheliopathy. Ophthalmology 2001; 108:1082-1087
- ↑ 11.0 11.1 Maffett MJ, Johns KJ, Parrish CM, et al. Sterile corneal ulceration after cataract extraction in patients with collagen vascular disease. Cornea 1990; 9:279-285
- ↑ 12.0 12.1 Perez VL, Azar DT, Foster CS. Sterile corneal melting and necrotizing scleritis after cataract surgery in patients with rheumatoid arthritis and collagen vascular disease. Semin Ophthalmol 2002; 17:124-130
- ↑ Insler MS, Boutros G, Boulware DW. Corneal ulceration following cataract surgery in patients with rheumatoid arthritis. J Am Intraocul Implant Soc 1985; 11: 594-597
- ↑ 14.0 14.1 14.2 14.3 14.4 14.5 Lahners WJ, Hardten DR, Lindstrom RL. Peripheral keratitis following laser in situ keratomileusis. J Refract Surg 2003; 19:671-675
- ↑ Alio JL, Perez-Santonja JJ, Rodriguez-Prats J. LASIK in patients with rheumatic diseases: a pilot study. Ophthalmology 2005; 12:1948-1954
- ↑ Li Y, Li HY. [Analysis of clinical characteristics and risk factors of corneal melting after laser in situ keratomileusis]. [Chinese]. Zhonghua Yan Ke Za Zhi 2005; 41:330-334
- ↑ Seiler T, Wollensak J. Complications of laser keratomileusis with the excimer laser. Klin Monatsbl Augenheilkd 1992:200:642-653
- ↑ Cua IY, Pepose JS. Late corneal scarring after photorefractive keratectomy concurrent with development of systemic lupus erythematosus. J Refract Surg 2002;18:750-752
- ↑ 19.0 19.1 Diaz-Valle D. Late-onset severe diffuse lamellar keratitis associated with uveitis after LASIK in a patient with ankylosing spondylitis. Journal of Refract Surg 1995;25:623
- ↑ 20.0 20.1 Schallhorn J, Schallhorn S, Hettinger K, Venter J, Pelouskova M, Teenan D, Hannan S. Outcomes and complications of excimer laser surgery in patients with collagen vascular and other immune-mediated inflammatory diseases. J Cataract Refract Surg 2016;42(12):1742-1752. doi: 10.1016/j.jcrs.2016.09.018.