Basic Considerations in the Diagnosis and Treatment of Iatrogenic Dry Eye Secondary to Vision Correction by Laser Surgery

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1 Basic Considerations in the Diagnosis and Treatment of Iatrogenic Dry Eye Secondary to Vision Correction by Laser Surgery Frank J. Holly, PhD Dry Eye Institute Yantis, Texas 2005 by Different by Design and Vision Surgery Rehab Network. All rights reserved.

2 About the author: Frank J. Holly, PhD Dr. Frank Holly acquired his background in chemical engineering at the Technical University of Budapest before emigrating to the Unites States, where he received his doctorate in physical chemistry from Cornell University. From the beginning of his research career, he has applied his combined knowledge of basic sciences and engineering. Among Dr. Holly s most significant, pioneering achievements has been the establishment of the modern basis of tear film physiology utilizing a multidisciplinary approach. His unique approach and insight resulted in his formulation of the next generation of eye drops that still, after 20 years, outperform all the other, more recently developed collyria for the treatment of dry eye. His association with the former Surgical Eyes Foundation (now the Vision Surgery Rehab Network) in 2001 enabled him to bring his eye drops to the attention of refractive surgical patients suffering from iatrogenic dry eyes. With the help of Joe Echols of Aqueous Pharma, Dr. Holly s drops, Dwelle, Dakrina and NutraTear, have offered relief to many patients who have tried everything else and failed. Founder and first president of the International Society of Dakryology, as well as the non-profit Dry Eye Institute, Dr. Holly was awarded the 1993 Lacrima Award in Madrid, Spain, for outstanding contributions to lacrimal physiology. He has authored 110 articles and edited several book treatises. Visit for more information about Professor Holly s research.

3 Various Methods of Refractive (Vision Correction) Surgery π Lasik (Laser-Assisted In-situ Keratomileusis) The most popular refractive surgical procedure. Proceeds in two steps to create the flap and then evaporate the tissue ( flap & zap ). π PRK (Photorefractive Keratectomy) Mechanically scrapes off epithelium prior to laser treatment present, still fairly common, especially with people having thin cornea.

4 Various Methods of Refractive (Vision Correction) Surgery (continued) π Lasek (Laser epithelial keratomileusis) Epithelium is treated with 20% ethanol (higher chain fatty alcohols would be more suitable, author), then detached from the basement membrane. After laser treatment, the tissue is replaced. Less common than Lasik, but slowly gaining ground. π RK (Radial Keratotomy) Available since the 1980s, radial cuts in the stroma with a diamond knife, or now, laser. No longer popular, but still performed, especially globally.

5 Surgical Complications Related to Dry Eye States π Selected complications* Corneal abrasions Corneal ulcers Dry eye Epithelial sloughing Contact lens intolerance Ocular pain (persistent) Exposed palpebral fissure Ptosis Corneal necrosis Diffuse lamellar keratitis Microcystic edema Foreign body sensation Keratitis (noninfectious) Headache Photophobia Recurrent epithelial erosion *(from a list of 80, used with permission of Sandy Keller,

6 Caveats of Refractive Surgery π With the advances made in refractive surgery, supported by intensive marketing efforts, more and more patients undergo this elective procedure. π At least one-half of post-surgical patients exhibit symptoms of dry eye. For some, dry eye will resolve within six months of surgery if managed rationally. Unfortunately, it seldom is. Excessive lago de lacrimus can be as harmful as a scanty shallow one.

7 Caveats of Refractive Surgery (continued) π This type of dry eye state is also complicated by abnormalities in the surface epithelium, disturbances in light refraction, impairment of lid-globe congruity, goblet cell deficiency and abnormal blinking pattern. π Both diminished tear secretion, as well as epiphora, have been observed. The dry eye states of such patients are complex and need to be treated knowledgeably and aggressively. Poorly placed plugs can be not only uncomfortable, but harmful, as well.

8 Treating Iatrogenic Dry Eye π The traditional antibiotic/steroidal treatment initially should be kept to a minimum. π Topical treatment with a high quality artificial tear* should be started on the third day. π Patient must ensure that eyelids are closed during the night. π Make sure that the lids are well lubricated with a highly wetting, low viscosity drop. * such a formulation is defined in the right column of the table on the next slide

9 Treating Iatrogenic Dry Eye (continued) π If the epithelium is loose, detaches easily, or sticks to the lid: DO NOT: DO: Use eye drops of enhanced Use low viscosity solutions viscosity (< 5 cps) Use hypertonic salt solutions Use solution of high oncotic pressure (> 50 mm Hg) Use benzalkonium chloride Use unpreserved or Busan 1507 or thimerosal preservatives preserved formulations Use incomplete wetting Use complete wetting solutions solutions

10 Treatment Modalities for Dry Eyes π Supplementation of aqueous tears tear substitutes, lacrimal inserts, etc. π Preservation of aqueous tears punctal plugs, punctal occlusion, goggles, etc. π Stimulation of aqueous tear secretion secretagogues, eledoisin, cyclosporine

11 Treatment Modalities for Dry Eyes (continued) π Tear Supplementation The use of tear substitutes (ophthalmic demulcents) is the mainstay of the treatment of the iatrogenic dry eye. x Unfortunately, it is widely believed that: l Enhanced viscosity is helpful. l All eye drops are created equal. l Hypotonic salt solutions are efficacious. l Preservative-free drops are necessarily better.

12 Treatment Modalities for Dry Eyes (continued) { While the truth is that: 9 Effective lubrication requires low viscosity and a continuous lubricating layer between the lid and the globe 9 Most commercial eye drops cannot form stable films 9 Colloidal hyperosmotic solutions are often needed

13 Aqueous Tear-Deficient Dry Eyes π Tear film and surrounding tear meniscus require less than 10 microliters of aqueous tear, a minimal amount. π Even if the lacrimal glands do not secrete that much tear, stroma will supply some by osmotic means. π High rate of evaporation caused by turbulence, combined with low relative humidity makes a difference π In the majority of cases, dry eyes are not the result of drying but of nonwetting!!!

14 Aqueous Tear-Deficient Dry Eyes (continued) The tear film rupture (dry spot formation) is, after all, the result of local non-wetting NOT of drying up!

15 World Wide Web Open Clinical Trial on Post-Lasik Patients With Regard to Dry Eye Management Conducted by the Dry Eye Institute, in cooperation with the former Surgical Eyes Foundation (now Vision Surgery Rehab Network)

16 Dry Eye Clinical Study An unusual clinical study was conducted via the internet with the participation of leaders and members of the former Surgical Eyes Foundation, now the Vision Surgery Rehab Network, in conjunction with the Dry Eye Institute. Participation also included eye care professionals treating the study sample of recuperating patients and Aqueous Pharma, which supplied the eye drops through a compounding pharmacy.

17 Dry Eye Clinical Study (continued) This approach excluded haphazard and harmful treatment modalities common in the treatment of post-lasik patients, such as the use of ointments, antibiotics for sterile inflammation, steroids for inflammation resulting from poor tear film stability, over-use of otherwise benign eye drops (flooding the ocular surface), and discontinuation of highly viscous drops and gels. Patient symptoms determined recommendation of the appropriate Aqueous Pharma drop/combination of drops. Patient feedback was considered in deciding both regimen and type of drops suggested.

18 Dry Eye Clinical Study (continued) Many of the study subjects reportedly had tried every available artificial tear product. In a poll of more than 200 subjects, conducted after six months of this open study, participants were asked to respond to the following statement with true, false, or uncertain : At least some of these [Aqueous Pharma] drops helped my condition more than other regimen(s) I have tried.

19 Dry Eye Clinical Study (continued) At least some of these [Aqueous Pharma] drops helped my condition more than other regimen(s) I have tried.

20 Lid-Globe Lubrication x Three major, erroneous assumptions of old, on which a SUB-PAR treatment of post-lasik complications has been built, are: l Lubricants of higher viscosity are more efficacious. l The continuity (stability) of the lubricating layer is irrelevant. l The fluid lubricant should be of oily composition.

21 Lid-Globe Lubrication (continued) { While the facts are: 9 Force transfer between adjacent moving surfaces (related to wear) is proportional to viscosity. 9 In hydrodynamic lubrication, the importance of the stability of the lubricating layer was only recently recognized [1995], even though it is an absolute requirement for achieving the least friction. This fluid layer must consist of an aqueous solution containing high-molecular-weight, polymeric materials at high dilution with film-stabilizing properties. 9 Direct comparison between lubricants for load-bearing joints and the lid-globe system are risky.

22 Lacrophilic Artificial Ophthalmic Demulcents (available from The Dry Eye Company*) π Dwelle, Dakrina, NutraTear These formulations contain a synergistic polymer mixture capable of completely wetting the hydrophobic surfaces of diseased cornea. Dwelle and Dakrina have an oncotic pressure over 60 mmhg, which assists healing of injured ocular surface cells. Dakrina has vitamin A palmitate complexed to a water-soluble polymer for treating mucin-deficient dry eyes. NutraTear contains vitamin B 12 (cyanocobalamine) to assist in healing the corneal surface. *through

23 Enhancing Tear Film Stability π Punctal plugs diminish drainage and may improve the tear meniscus Discontinuous, scanty or narrow (<0.10 mm) tear meniscus is indicative of insufficient tear volume. The placement of punctal plugs, or punctal occlusion may ameliorate the condition. Punctal plugs are not a panacea, however. Epiphora or discomfort are indications for removal. All four puncta should only be plugged in desperate cases. Punctal plugs should be used with caution!

24 Enhancing Tear Film Stability (continued) π LIPID OINTMENTS adversely affect tear film stability This problem has not been adequately studied. Lipids used in ointments are mostly apolar and do not spread on hydrophilic surfaces. The quantity applied is enormous compared to the mucus layer s capacity to handle lipid contamination. The hydrophobic contamination may be more than the lacrimal system can handle, resulting in blurry vision and interfering with the hydrodynamic lubrication of the lids. Lipid ointments should not be used at all!!!

25 Conclusions π Treatment of post-surgical dry eye Avoid frequent instillation (<30 ) of any type of aqueous collyria. Use minimal steroid and/or antibiotic treatment if/as needed. For abnormally short tear film break-up time (TBUT) instill NT, DK, DW*. For leaky, loose epithelium (recurrent corneal erosion) instill DW. If short TBUT and goblet cell or mucin deficiency, instill DK. Drops are available through *NT=NutraTear, DK=Dakrina, DW=Dwelle

26 Remarks π After several weeks of experimentation with the various drops, an efficacious combination of drops may be determined for the individual patient. For example, Dakrina and NutraTear work well in combination (DK in the mornings and evenings, NT during the day).

27 Vision Surgery Rehab Network, NFP The Vision Surgery Rehab Network, NFP, (VSRN) is a not-for-profit, patient advocacy organization comprised entirely of volunteers committed to making a difference. VSRN s purpose is fourfold: increase understanding and awareness of causes of vision surgery complications; facilitate optical, medical and/or surgical rehabilitation of chronic visual, physical and/or psychological effects of vision surgery complications; promote development of effective non-surgical and surgical means to reduce or eliminate complications; and advise patients, eye care practitioners and surgical instrument and device manufacturers of contraindications of various vision surgeries. VSRN s primary focus is rehabilitation of complications from the various types of vision surgeries, from vision correction to cataract and corneal transplant surgeries, among others. Working with a dedicated, caring core of individuals and organizations, VSRN hopes to establish a wide network of resources that will fulfill our purpose and bring hope and help to those living with vision surgery complications. The scope of our activities will address, in addition to rehabilitation, the need for true informed consent for elective vision surgeries, prevention of complications, and public awareness of the broad impact of vision surgery complications in all areas of patients lives. For information about how to contribute to the success of the VSRN, graphic communications Copyright 2005 by Different by Design Graphic Communications and the Vision Surgery Rehab Network. Developed and produced by Different by Design Graphic Communications solely for the use of the Vision Surgery Rehab Network (VSRN), no part of this document may be copied or used for any purpose without the express permission of Different by Design Graphic Communications or VSRN. All rights reserved.

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