Should Laser Refractive Surgery Be Delayed?The Benefits in Deferring Laser Refractive Surgery Outweigh the DisadvantagesCONTROVERSIES (Schachat AP, ed)controversies (schachat ap, ed)Decision Makingdecision makingKeratomileusiskeratomileusisKeratectomy, Photorefractive, Excimer Laserkeratectomy, photorefractive, excimer laserLaser Surgerylaser surgeryLeo J.MaguireRochester, MinnNot AvailableTHINK OF people you care about. Imagine them making an important economic decision on a subject they do not understand. Questions inevitably come to mind. Will the product they want to purchase be less expensive later? Does it have a good track history? Is it of high quality and durable? Will it soon be of higher quality and durability? Complicated answers will follow these questions. The only question with a simple answer, albeit deceptively simple, comes at the end of all the talk and confusion: Do you want to make the purchase now or wait?The editors of the ARCHIVES specify a dilemma of this kind. Should someone have laser-based refractive eye surgery now or wait? Rather than answer that deceptively simple question yes or no, let's ask and then answer the more complex questions that precede the final decision. I will give those answers a cautionary spin as that is the role of this article in the debate. Of course, the final decision lies with the patient.WILL THE COST OF SURGERY BE LOWER LATER?Refractive surgery is a retail business in a medical setting. Patient demand for the service was lower than predicted in 1996 and laser stocks suffered as a consequence. Most laser centers suffered as well, with patient volume below the level needed for profitability. When sales are slow, marketing increases first, but if sales remain slow, prices will drop. Few patients are paying the $2500 fee that has been common in the United States. Surgical fees have yet to reach the low price currently available in England. Concerned about price? Wait a while.TRACK HISTORY OF LASER PROCEDURESGeorge Waring, MD, eloquently described a general trend in refractive surgery that bears repeating here:The urge to use the latest surgical technique is particularly strong in refractive surgery because development is rapid, surgeons want to offer patients the most current advantages, there is a prevalent attitude of hype, competition is intense to gain professional leadership, and the economic stakes are high for both practitioners and industry. These factors push unproven techniques into clinical use before their advantages and disadvantages are well defined, creating a pattern . . . that is unhealthy for refractive surgeons and patientsWe find a better scientific track record for photorefractive keratectomy than many other refractive procedures. Much less extensive peer-reviewed information is available for laser-assisted in situ keratomileusis (LASIK). Nonetheless, these 2 procedures are not immune to the atmosphere that has existed in the field of refractive surgery during the past decade. Few scientific articles report on the VISX (VISX Inc, Sunnyvale, Calif) and Summit (Summit Technology Inc, Waltham, Mass) Food and Drug Administration trials of photorefractive keratectomy. Most of these articles present only Snellen acuity results and manifest refraction results despite evidence that these measures are insensitive to latent hyperopia, night aberration, central islands, decentration, glare, refractive instability, and late onset of severe central corneal scarring.ARE LASER-BASED PROCEDURES OF UNIFORMLY HIGH QUALITY?The short answer to this question is no. Perform the same refractive procedure on a consecutive group of patients, and variations will occur in optical performance. Some of these variations can interfere with 1 or more important visual tasks, including night vision, motor vehicle operation, and management of tasks requiring fine visual discrimination.These aberrations can occur even in patients with 20/20 uncorrected visual acuity after surgery.Witness the initial US Navy study of excimer photorefractive keratectomy for moderate myopia.All 33 eyes studied had visual acuity of 20/20 without spectacle correction 1 year after surgery, which is a uniformly excellent result. Legally, all these patients could operate a motor vehicle without spectacle correction. Still, cycloplegic refraction showed a high incidence of latent hyperopia with 5 of 33 eyes +1.00 diopter or greater. One patient developed severe night vision aberration and refused surgery in the other eye. Two additional patients complained of moderately severe glare or halo effect. Obviously a refractive underclass exists here even in a study in which everyone has visual acuity of 20/20 without glasses.Are newer nomograms or improved lasers the answer? We will know when scientific publications consistently report optical quality results that are as good as or better than those of the Navy study.Variability is seen in LASIK procedures as well. Ioannis Pallikaris, MD, a leading innovator in LASIK, noted clinically important amounts of decentration in a large subset of patients who underwent LASIK. In a group of 200 consecutive cases presented at the 1996 meeting of the Association for Research in Vision and Ophthalmology, 10% showed 102 mm of ablation decentration and another 10% showed 2 to 3 mm of decentration.Those amounts of decentration significantly impair optical quality, especially at night. Further published research is needed on problems with optical quality, especially in patients with higher amounts of myopia. Laser-assisted in situ keratomileusis is a fascinating procedure that should evolve rapidly. One can make a compelling argument for at least a short delay with so much uncertainty remaining about nomograms, microkeratome-related complications, learning curves,central islands, and refractive stability.ARE LASER-BASED PROCEDURES UNIFORMLY DURABLE AND STABLE?The short answer is that we do not know. Laser refractive surgery arrived so recently and laser technology changes so rapidly that long-term complications cannot be known. We do not know if late-onset corneal scarring will be limited to early-generation surface ablationor will occur in later-generation models and/or LASIK. The long-term stability and optical quality of LASIK is still unknown. Time will tell, just as it did for intraocular lens implants. We will not know for years which laser procedures will perform like the infamous closed loop intraocular lenses (excellent early results, frequent late complications) and which will perform as the highly reliable posterior chamber lenses (excellent safety and durability).WILL LASER-BASED PROCEDURES SOON BE OF HIGHER QUALITY AND DURABILITY?Time will tell. If quality improves as quickly in the next 10 years as it did in the past 10 years, a wait of even 2 to 3 years will be worthwhile, especially given the recent trend to use LASIK rather than photorefractive keratectomy for even low myopia.The undeniable truth of laser refractive surgery is that our knowledge will only advance if a sizable group decide to have the surgery now when many questions about optical quality and stability remain incompletely answered. Our knowledge will advance faster if high-volume centers around the world publish more comprehensive analyses of measures of optical quality so patients can understand how far we have progressed. When the scientific press contains uniformly excellent short- and long-term results with laser-based surgery, the rationale for delay will vanish.GOWaringEvaluating new refractive surgical procedures: free market madness versus regulatory rigor mortis.J Refract Surg.1995;11:335-339.LJMaguireKeratorefractive surgery, success, and the public health.Am J Ophthalmol.1994;117:394-398.BLHallidayRefractive and visual results and patient satisfaction after excimer laser photorefractive keratectomy for myopia.Br J Ophthalmol.1995;79:881-887.SCSchallhornCLBlantonSEKauppPreliminary results of photorefractive keratectomy in active-duty United States Navy personnel.Ophthalmology.1996;103:5-22.JCMeyerRDStultingKPThompsonOSDurrieLate onset of corneal scar after excimer laser photorefractive keratectomy.Am J Ophthalmol.1996;121:529-539.ILipshitzALoewensteinDVarssanoMLazarLate onset corneal haze after photorefractive keratectomy for moderate and high myopia.Ophthalmology.1997;104:369-374.MKriegerowskiTSchloteMDerseHRassmannJThielBJeanMesopic vision correction of myopia: soft contact lenses, spectacles, and photorefractive keratectomy.Invest Ophthalmol Vis Sci.1997;38(ARVO abstract):S531.TSchloteMKriegerowskiMDerseJThielBJeanExperience and satisfaction of patients after photorefractive keratectomy (PRK).Invest Ophthalmol Vis Sci.1997;38(ARVO abstract):S426.MJTassignonFJVan de VeldeRTrauOptical characteristics of the cornea after refractive surgery using scanning laser ophthalmoscopy.Invest Ophthalmol Vis Sci.1997;38(ARVO abstract):S531.SCSchallhornCLBlantonSEKauppNight driving performance as functional test of visual performance after photorefractive keratectomy.Invest Ophthalmol Vis Sci.1997;38(ARVO abstract):S531.DSSiganosIGPallikarisETDetorakisGGKlonosTGPapadakiNIAstirakakisTopographic changes in LASIK.Invest Ophthalmol Vis Sci.1996;37(ARVO abstract):S569.HVGimbelSBastiGBKayeMFerensowiczExperience during the learning curve of laser in situ keratomileusis.J Cataract Refract Surg.1996;22:542-550.AMFendrickCSGoodmanJDTrobeThe effectiveness initiative, II: the spectrum of effectiveness research.Arch Ophthalmol.1995;113:862-865.Reprints: Leo J. Maguire, MD, Mayo Clinic, 200 First St SW, Rochester, MN 55905 (e-mail: maguire.leo@mayo.edu).
Should Laser Refractive Surgery Be Delayed?The Benefits in Deferring Laser Refractive Surgery...
1998-05-01 00:00:00
CONTROVERSIES SECTION EDITOR: ANDREW P. SCHACHAT, MD Should Laser Refractive Surgery Be Delayed? The Benefits in Deferring Laser Refractive Surgery Outweigh the Disadvantages HINK OF people you care about. Imagine them making an important economic deci- sion on a subject they do not understand. Questions inevitably come to mind. Will the product they want to purchase be less expensive later? Does it have a good track his- T tory? Is it of high quality and durable? Will it soon be of higher quality and durability? Complicated answers will follow these questions. The only question with a simple answer, albeit deceptively simple, comes at the end of all the talk and confusion: Do you want to make the pur- chase now or wait? The editors of the ARCHIVES specify a di- offer patients the most current advantages, there is a prevalent attitude of hype, competition is lemma of this kind. Should someone have intense to gain professional leadership, and the laser-based refractive eye surgery now or economic stakes are high for both practition- wait? Rather than answer that deceptively ers and industry. These factors push un- simple question yes or no, let’s ask and then proven techniques into clinical use
http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.pngJAMA OphthalmologyAmerican Medical Associationhttp://www.deepdyve.com/lp/american-medical-association/should-laser-refractive-surgery-be-delayed-the-benefits-in-deferring-euvtq3hzPP
Should Laser Refractive Surgery Be Delayed?The Benefits in Deferring Laser Refractive Surgery Outweigh the DisadvantagesCONTROVERSIES (Schachat AP, ed)controversies (schachat ap, ed)Decision Makingdecision makingKeratomileusiskeratomileusisKeratectomy, Photorefractive, Excimer Laserkeratectomy, photorefractive, excimer laserLaser Surgerylaser surgeryLeo J.MaguireRochester, MinnNot AvailableTHINK OF people you care about. Imagine them making an important economic decision on a subject they do not understand. Questions inevitably come to mind. Will the product they want to purchase be less expensive later? Does it have a good track history? Is it of high quality and durable? Will it soon be of higher quality and durability? Complicated answers will follow these questions. The only question with a simple answer, albeit deceptively simple, comes at the end of all the talk and confusion: Do you want to make the purchase now or wait?The editors of the ARCHIVES specify a dilemma of this kind. Should someone have laser-based refractive eye surgery now or wait? Rather than answer that deceptively simple question yes or no, let's ask and then answer the more complex questions that precede the final decision. I will give those answers a cautionary spin as that is the role of this article in the debate. Of course, the final decision lies with the patient.WILL THE COST OF SURGERY BE LOWER LATER?Refractive surgery is a retail business in a medical setting. Patient demand for the service was lower than predicted in 1996 and laser stocks suffered as a consequence. Most laser centers suffered as well, with patient volume below the level needed for profitability. When sales are slow, marketing increases first, but if sales remain slow, prices will drop. Few patients are paying the $2500 fee that has been common in the United States. Surgical fees have yet to reach the low price currently available in England. Concerned about price? Wait a while.TRACK HISTORY OF LASER PROCEDURESGeorge Waring, MD, eloquently described a general trend in refractive surgery that bears repeating here:The urge to use the latest surgical technique is particularly strong in refractive surgery because development is rapid, surgeons want to offer patients the most current advantages, there is a prevalent attitude of hype, competition is intense to gain professional leadership, and the economic stakes are high for both practitioners and industry. These factors push unproven techniques into clinical use before their advantages and disadvantages are well defined, creating a pattern . . . that is unhealthy for refractive surgeons and patientsWe find a better scientific track record for photorefractive keratectomy than many other refractive procedures. Much less extensive peer-reviewed information is available for laser-assisted in situ keratomileusis (LASIK). Nonetheless, these 2 procedures are not immune to the atmosphere that has existed in the field of refractive surgery during the past decade. Few scientific articles report on the VISX (VISX Inc, Sunnyvale, Calif) and Summit (Summit Technology Inc, Waltham, Mass) Food and Drug Administration trials of photorefractive keratectomy. Most of these articles present only Snellen acuity results and manifest refraction results despite evidence that these measures are insensitive to latent hyperopia, night aberration, central islands, decentration, glare, refractive instability, and late onset of severe central corneal scarring.ARE LASER-BASED PROCEDURES OF UNIFORMLY HIGH QUALITY?The short answer to this question is no. Perform the same refractive procedure on a consecutive group of patients, and variations will occur in optical performance. Some of these variations can interfere with 1 or more important visual tasks, including night vision, motor vehicle operation, and management of tasks requiring fine visual discrimination.These aberrations can occur even in patients with 20/20 uncorrected visual acuity after surgery.Witness the initial US Navy study of excimer photorefractive keratectomy for moderate myopia.All 33 eyes studied had visual acuity of 20/20 without spectacle correction 1 year after surgery, which is a uniformly excellent result. Legally, all these patients could operate a motor vehicle without spectacle correction. Still, cycloplegic refraction showed a high incidence of latent hyperopia with 5 of 33 eyes +1.00 diopter or greater. One patient developed severe night vision aberration and refused surgery in the other eye. Two additional patients complained of moderately severe glare or halo effect. Obviously a refractive underclass exists here even in a study in which everyone has visual acuity of 20/20 without glasses.Are newer nomograms or improved lasers the answer? We will know when scientific publications consistently report optical quality results that are as good as or better than those of the Navy study.Variability is seen in LASIK procedures as well. Ioannis Pallikaris, MD, a leading innovator in LASIK, noted clinically important amounts of decentration in a large subset of patients who underwent LASIK. In a group of 200 consecutive cases presented at the 1996 meeting of the Association for Research in Vision and Ophthalmology, 10% showed 102 mm of ablation decentration and another 10% showed 2 to 3 mm of decentration.Those amounts of decentration significantly impair optical quality, especially at night. Further published research is needed on problems with optical quality, especially in patients with higher amounts of myopia. Laser-assisted in situ keratomileusis is a fascinating procedure that should evolve rapidly. One can make a compelling argument for at least a short delay with so much uncertainty remaining about nomograms, microkeratome-related complications, learning curves,central islands, and refractive stability.ARE LASER-BASED PROCEDURES UNIFORMLY DURABLE AND STABLE?The short answer is that we do not know. Laser refractive surgery arrived so recently and laser technology changes so rapidly that long-term complications cannot be known. We do not know if late-onset corneal scarring will be limited to early-generation surface ablationor will occur in later-generation models and/or LASIK. The long-term stability and optical quality of LASIK is still unknown. Time will tell, just as it did for intraocular lens implants. We will not know for years which laser procedures will perform like the infamous closed loop intraocular lenses (excellent early results, frequent late complications) and which will perform as the highly reliable posterior chamber lenses (excellent safety and durability).WILL LASER-BASED PROCEDURES SOON BE OF HIGHER QUALITY AND DURABILITY?Time will tell. If quality improves as quickly in the next 10 years as it did in the past 10 years, a wait of even 2 to 3 years will be worthwhile, especially given the recent trend to use LASIK rather than photorefractive keratectomy for even low myopia.The undeniable truth of laser refractive surgery is that our knowledge will only advance if a sizable group decide to have the surgery now when many questions about optical quality and stability remain incompletely answered. Our knowledge will advance faster if high-volume centers around the world publish more comprehensive analyses of measures of optical quality so patients can understand how far we have progressed. When the scientific press contains uniformly excellent short- and long-term results with laser-based surgery, the rationale for delay will vanish.GOWaringEvaluating new refractive surgical procedures: free market madness versus regulatory rigor mortis.J Refract Surg.1995;11:335-339.LJMaguireKeratorefractive surgery, success, and the public health.Am J Ophthalmol.1994;117:394-398.BLHallidayRefractive and visual results and patient satisfaction after excimer laser photorefractive keratectomy for myopia.Br J Ophthalmol.1995;79:881-887.SCSchallhornCLBlantonSEKauppPreliminary results of photorefractive keratectomy in active-duty United States Navy personnel.Ophthalmology.1996;103:5-22.JCMeyerRDStultingKPThompsonOSDurrieLate onset of corneal scar after excimer laser photorefractive keratectomy.Am J Ophthalmol.1996;121:529-539.ILipshitzALoewensteinDVarssanoMLazarLate onset corneal haze after photorefractive keratectomy for moderate and high myopia.Ophthalmology.1997;104:369-374.MKriegerowskiTSchloteMDerseHRassmannJThielBJeanMesopic vision correction of myopia: soft contact lenses, spectacles, and photorefractive keratectomy.Invest Ophthalmol Vis Sci.1997;38(ARVO abstract):S531.TSchloteMKriegerowskiMDerseJThielBJeanExperience and satisfaction of patients after photorefractive keratectomy (PRK).Invest Ophthalmol Vis Sci.1997;38(ARVO abstract):S426.MJTassignonFJVan de VeldeRTrauOptical characteristics of the cornea after refractive surgery using scanning laser ophthalmoscopy.Invest Ophthalmol Vis Sci.1997;38(ARVO abstract):S531.SCSchallhornCLBlantonSEKauppNight driving performance as functional test of visual performance after photorefractive keratectomy.Invest Ophthalmol Vis Sci.1997;38(ARVO abstract):S531.DSSiganosIGPallikarisETDetorakisGGKlonosTGPapadakiNIAstirakakisTopographic changes in LASIK.Invest Ophthalmol Vis Sci.1996;37(ARVO abstract):S569.HVGimbelSBastiGBKayeMFerensowiczExperience during the learning curve of laser in situ keratomileusis.J Cataract Refract Surg.1996;22:542-550.AMFendrickCSGoodmanJDTrobeThe effectiveness initiative, II: the spectrum of effectiveness research.Arch Ophthalmol.1995;113:862-865.Reprints: Leo J. Maguire, MD, Mayo Clinic, 200 First St SW, Rochester, MN 55905 (e-mail: maguire.leo@mayo.edu).
CONTROVERSIES SECTION EDITOR: ANDREW P. SCHACHAT, MD Should Laser Refractive Surgery Be Delayed? The Benefits in Deferring Laser Refractive Surgery Outweigh the Disadvantages HINK OF people you care about. Imagine them making an important economic deci- sion on a subject they do not understand. Questions inevitably come to mind. Will the product they want to purchase be less expensive later? Does it have a good track his- T tory? Is it of high quality and durable? Will it soon be of higher quality and durability? Complicated answers will follow these questions. The only question with a simple answer, albeit deceptively simple, comes at the end of all the talk and confusion: Do you want to make the pur- chase now or wait? The editors of the ARCHIVES specify a di- offer patients the most current advantages, there is a prevalent attitude of hype, competition is lemma of this kind. Should someone have intense to gain professional leadership, and the laser-based refractive eye surgery now or economic stakes are high for both practition- wait? Rather than answer that deceptively ers and industry. These factors push un- simple question yes or no, let’s ask and then proven techniques into clinical use
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