- Email: [email protected]
Phakic implantation of flexible iris prosthesis
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LETTERS
riboflavin for ultraviolet light (365 nm). J Refract Surg 2011; 27:195–201 Friedman MD, Pertaub R, Usher D, Sherr E, Kamaev P, Muller D. Advanced corneal cross-linking system with fluorescence dosimetry. J Ophthalmol 2012 Article ID303459. Available at: http:// downloads.hindawi.com/journals/jop/2012/303459.pdf. Accessed September 18, 2012 Spoerl E, Hoyer A, Pillunat LE, Raiskup F. Corneal cross-linking and safety issues. Open Ophthalmol J 2011; 5:14–16. Available at: http://www.ncbi.nlm.nih.gov/pmc/ articles/PMC3052642/pdf/TOOPHTJ-5-14.pdf. Accessed September 18, 2012 €rl E, Seiler T. Behandlung von Keratoconus Wollensak G, Spo durch Kollagenvernetzung [Treatment of keratoconus by collagen cross linking]. Ophthalmologe 2003; 100:44–49 Kanellopoulos AJ. Long-term safety and efficacy follow-up of prophylactic higher fluence collagen cross-linking in high myopic laser-assisted in situ keratomileusis. Clin Ophthalmol 2012; 6:1125–1130. Available at: http://www.ncbi.nlm.nih.gov/pmc/ articles/PMC3413339/pdf/opth-6-1125.pdf. Accessed September 18, 2012
Phakic implantation of flexible iris prosthesis While we admire the technical expertise achieved in Magnus et al.'s1 first published implantation of a custom flexible iris prosthesis in a phakic eye, our now 100-eye case series with this device makes us uncertain whether this reported case is translatable to other phakic patients. Implantation of the device in a phakic anterior segment without intraoperative damage to the crystalline lens requires extraordinary surgical dexterity, for which Dr. Tassignon is well recognized, yet may not be achieved in every case with even the most gifted surgeons. Although the eye described had an existing cataract, which was reported not to progress on biomicroscopy, the possibility of progression cannot be eliminated in this patient with limited retinal potential because subtle progression is not always easily documented on slitlamp examination. Furthermore, if the cataract progresses sectorally, underlying the prosthesis, the changes would be undisclosed to the examiner, who cannot view that portion of the lens through the opaque device. Additionally, while this defect was traumatic, inflammatory conditions can present with similar sectoral iris loss, which may have an even greater risk for inflammation with surgical manipulation of the uveal tissue. Our strong preference for iris supplementation in such cases is to render the patient pseudophakic and then place the iris device and a posterior chamber intraocular lens entirely within the confines of the capsular bag, where no uveal contact can occur. We have achieved highly satisfactory results with in-the-bag placement (Figure 1).2,A–E We also wonder about long-term fixation of this segment in a 55-year-old patient due to the lifespan of 10-0
Figure 1. In-the-bag implantation of a silicone foldable customized iris prosthesis. Yellow arrow indicates old pigment on the capsulorrhexis margin. The white arrow identifies capsulorrhexis margin fibrosis.
polypropylene, with possible hydrolysis over 7 to 14 years.3 We concur that the custom flexible iris device is an incredibly useful tool to reduce photic symptoms and, happily, also yields a pleasing improvement in appearance. Still, we recommend extreme caution in considering phakic implantation. We believe cataract extraction prior to device placement increases the margin of safety. Michael E. Snyder, MD Mauricio A. Perez, MD Cincinnati, Ohio, USA Dr. Snyder is a consultant for HumanOptics AG, Alcon Laboratories Inc., and Haag-Streit AG and an investigator for Ocular Therapeutix, Inc. REFERENCES 1. Magnus J, Trau R, Mathysen DGP, Tassignon M-J. Safety of an artificial iris in a phakic eye. J Cataract Refract Surg 2012; 38:1097–1100 2. Snyder ME. Staining the capsule in congenital aniridic eyes. J Cataract Refract Surg 2012; 38:373–374 3. Price MO, Price FW Jr, Werner L, Berlie C, Mamalis N. Late dislocation of scleral-sutured posterior chamber intraocular lenses. J Cataract Refract Surg 2005; 31:1320–1326
OTHER CITED MATERIAL A. Snyder ME, “Anterior Segment Grand Rounds; A Puzzle Missing a Few Pieces,” EyeWorld, November 2011. Available at: http:// eyeworld.org/article.php?sidZ6102. Accessed September 14, 2012
J CATARACT REFRACT SURG - VOL 38, DECEMBER 2012
LETTERS
B. Perez MA, Snyder ME, “Tips and Tricks for Managing Cataract Surgery in Patients with ICE Syndrome,” film presented at the ASCRS Symposium on Cataract, IOL and Refractive Surgery, Chicago, Illinois, USA, April 2012 C. Snyder ME, “Fixing an Iris “Oops” with Custom Iris Prosthesis,” film presented at the ASCRS Symposium on Cataract, IOL and Refractive Surgery, Chicago, Illinois, USA, April 2012 D. Snyder ME, “Epithelial Downgrowth: Doomed to Defeat or Surgical Success,” film presented at the ASCRS Symposium on Cataract, IOL and Refractive Surgery, San Diego, California, USA, March 2011 E. Snyder ME, “Cataract and Lost Iris Tissue After Trauma,” Cataract & Refractive Surgery Today, January 2012. Available at: http://bmctoday.net/crstoday/2012/01/article.asp?fZ cataract-and-lost-iris-tissue-after-trauma. Accessed September 14, 2012
Reply : I appreciate the nice words about the surgical results in this particular case. Although it looks spectacular, the procedure was not that challenging for the lens since we have ophthalmic viscosurgical devices at our disposal to mechanically lift the iris from the lens, allowing safe manipulation of the 10-0 polypropylene (Prolene) needle in the anterior segment of the eye. Cataract formation behind the artificial iris is not an issue since it will hardly influence the patient's quality of vision. A sectorial artificial iris will not prevent dilation of the remaining iris provided the sphincter is intact, as it was in the case in our article. I do agree that I would not have performed this sequence of surgery if the remaining iris had not had an intact sphincter. I would have followed the proposal of Drs. Snyder and Perez and performed the cataract surgery first and then repaired the iris in the same surgical procedure. I am not too concerned about the possible resorption of the polypropylene over time. The iris is a very reactive tissue and will cover the artificial iris with a thin layer of fibrotic tissue to encapsulate this foreign body. It might influence the color slightly but not the stability of this tissue within the patient's eye. However, I do appreciate the comments that allow me to add the precision that was lacking in the original article: The use of polypropylene 10-0 will probably not jeopardize the stability of the iris prosthesis over time because of the particularly strong healing properties of the iris.dMarie-Jose B.R. Tassignon, PhD, MD
Ethical responsibility to disclose surgical errors Lau and Chan1 began their recent case report of incorrect intraocular lens (IOL) implantation with a review of content summary from 3 respected journals and the conclusion that “patients' needs and safety and ethical issues are not of high concern even though these areas are important in providing quality service and enhancing institutions' reputations.” Yet, although the patient described in their case report
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had subsequent IOL exchange surgery, “the truth of the surgical error remained undisclosed to the patient throughout the recovery period.” The incorrect IOL insertion crisis management protocol presented fails to address the ethical responsibility of the surgeon to disclose surgical error. There is consensus among professional societies, ethicists, and the general public that physicians are obligated to disclose medical errors that cause adverse effects to patients.2 The American Medical Association's Code of Medical Ethics3 states that “it is a fundamental ethical requirement that a physician should at all times deal honestly and openly with patients. Patients have a right to know their past and present medical status and be free of any mistaken beliefs concerning their conditions. Situations occasionally occur in which a patient suffers significant medical complications that may have resulted from the physician's mistake or judgment. In these situations, the physician is ethically required to inform the patient of all the facts necessary to ensure understanding of what has occurred. Only through full disclosure is a patient able to make informed decisions regarding future medical care.” Without disclosure to the patient, how can the patient make an informed choice to proceed with IOL exchange (versus alternative options, including seeking a second opinion)? Patients and family members want providers to explain what happened when adverse events occur, to express caring for the patient, and to feel remorse.4 Full disclosure leads to greater trust and more positive regard, particularly when the physician acknowledges responsibility and apologizes for the adverse event. Full disclosure and acceptance of responsibility do not appear to increase intention to sue.2 While prevention of incorrect IOL surgery using the “5 rights” (right patient, right site, right procedure, right model, right IOL power)1 is a laudable goal, when things do go astray one should not forget the patient's rights. Preston H. Blomquist, MD Dallas, Texas, USA
REFERENCES 1. Lau KY, Chan ZCY. Crisis management after incorrect intraocular lens insertion. J Cataract Refract Surg 2012; 38:1499–1501 2. Wu AW, Huang I-C, Stokes S, Pronovost PJ. Disclosing medical errors to patients: it’s not what you say, it’s what they hear. J Gen Intern Med 2009; 24:1012–1017. Available at: http:// www.ncbi.nlm.nih.gov/pmc/articles/PMC2726881/pdf/11606_ 2009_Article_1044.pdf. Accessed September 14, 2012 3. American Medical Association Code of Medical Ethics, Opinion 8.12-Patient Information. Issued March 1981, updated June 1994. Available at: http://www.ama-assn.org/ama/pub/ physician-resources/medical-ethics/code-medical-ethics/opinion 812.page? Accessed September 14, 2012
J CATARACT REFRACT SURG - VOL 38, DECEMBER 2012
2.
3.
4.
5.
LETTERS
riboflavin for ultraviolet light (365 nm). J Refract Surg 2011; 27:195–201 Friedman MD, Pertaub R, Usher D, Sherr E, Kamaev P, Muller D. Advanced corneal cross-linking system with fluorescence dosimetry. J Ophthalmol 2012 Article ID303459. Available at: http:// downloads.hindawi.com/journals/jop/2012/303459.pdf. Accessed September 18, 2012 Spoerl E, Hoyer A, Pillunat LE, Raiskup F. Corneal cross-linking and safety issues. Open Ophthalmol J 2011; 5:14–16. Available at: http://www.ncbi.nlm.nih.gov/pmc/ articles/PMC3052642/pdf/TOOPHTJ-5-14.pdf. Accessed September 18, 2012 €rl E, Seiler T. Behandlung von Keratoconus Wollensak G, Spo durch Kollagenvernetzung [Treatment of keratoconus by collagen cross linking]. Ophthalmologe 2003; 100:44–49 Kanellopoulos AJ. Long-term safety and efficacy follow-up of prophylactic higher fluence collagen cross-linking in high myopic laser-assisted in situ keratomileusis. Clin Ophthalmol 2012; 6:1125–1130. Available at: http://www.ncbi.nlm.nih.gov/pmc/ articles/PMC3413339/pdf/opth-6-1125.pdf. Accessed September 18, 2012
Phakic implantation of flexible iris prosthesis While we admire the technical expertise achieved in Magnus et al.'s1 first published implantation of a custom flexible iris prosthesis in a phakic eye, our now 100-eye case series with this device makes us uncertain whether this reported case is translatable to other phakic patients. Implantation of the device in a phakic anterior segment without intraoperative damage to the crystalline lens requires extraordinary surgical dexterity, for which Dr. Tassignon is well recognized, yet may not be achieved in every case with even the most gifted surgeons. Although the eye described had an existing cataract, which was reported not to progress on biomicroscopy, the possibility of progression cannot be eliminated in this patient with limited retinal potential because subtle progression is not always easily documented on slitlamp examination. Furthermore, if the cataract progresses sectorally, underlying the prosthesis, the changes would be undisclosed to the examiner, who cannot view that portion of the lens through the opaque device. Additionally, while this defect was traumatic, inflammatory conditions can present with similar sectoral iris loss, which may have an even greater risk for inflammation with surgical manipulation of the uveal tissue. Our strong preference for iris supplementation in such cases is to render the patient pseudophakic and then place the iris device and a posterior chamber intraocular lens entirely within the confines of the capsular bag, where no uveal contact can occur. We have achieved highly satisfactory results with in-the-bag placement (Figure 1).2,A–E We also wonder about long-term fixation of this segment in a 55-year-old patient due to the lifespan of 10-0
Figure 1. In-the-bag implantation of a silicone foldable customized iris prosthesis. Yellow arrow indicates old pigment on the capsulorrhexis margin. The white arrow identifies capsulorrhexis margin fibrosis.
polypropylene, with possible hydrolysis over 7 to 14 years.3 We concur that the custom flexible iris device is an incredibly useful tool to reduce photic symptoms and, happily, also yields a pleasing improvement in appearance. Still, we recommend extreme caution in considering phakic implantation. We believe cataract extraction prior to device placement increases the margin of safety. Michael E. Snyder, MD Mauricio A. Perez, MD Cincinnati, Ohio, USA Dr. Snyder is a consultant for HumanOptics AG, Alcon Laboratories Inc., and Haag-Streit AG and an investigator for Ocular Therapeutix, Inc. REFERENCES 1. Magnus J, Trau R, Mathysen DGP, Tassignon M-J. Safety of an artificial iris in a phakic eye. J Cataract Refract Surg 2012; 38:1097–1100 2. Snyder ME. Staining the capsule in congenital aniridic eyes. J Cataract Refract Surg 2012; 38:373–374 3. Price MO, Price FW Jr, Werner L, Berlie C, Mamalis N. Late dislocation of scleral-sutured posterior chamber intraocular lenses. J Cataract Refract Surg 2005; 31:1320–1326
OTHER CITED MATERIAL A. Snyder ME, “Anterior Segment Grand Rounds; A Puzzle Missing a Few Pieces,” EyeWorld, November 2011. Available at: http:// eyeworld.org/article.php?sidZ6102. Accessed September 14, 2012
J CATARACT REFRACT SURG - VOL 38, DECEMBER 2012
LETTERS
B. Perez MA, Snyder ME, “Tips and Tricks for Managing Cataract Surgery in Patients with ICE Syndrome,” film presented at the ASCRS Symposium on Cataract, IOL and Refractive Surgery, Chicago, Illinois, USA, April 2012 C. Snyder ME, “Fixing an Iris “Oops” with Custom Iris Prosthesis,” film presented at the ASCRS Symposium on Cataract, IOL and Refractive Surgery, Chicago, Illinois, USA, April 2012 D. Snyder ME, “Epithelial Downgrowth: Doomed to Defeat or Surgical Success,” film presented at the ASCRS Symposium on Cataract, IOL and Refractive Surgery, San Diego, California, USA, March 2011 E. Snyder ME, “Cataract and Lost Iris Tissue After Trauma,” Cataract & Refractive Surgery Today, January 2012. Available at: http://bmctoday.net/crstoday/2012/01/article.asp?fZ cataract-and-lost-iris-tissue-after-trauma. Accessed September 14, 2012
Reply : I appreciate the nice words about the surgical results in this particular case. Although it looks spectacular, the procedure was not that challenging for the lens since we have ophthalmic viscosurgical devices at our disposal to mechanically lift the iris from the lens, allowing safe manipulation of the 10-0 polypropylene (Prolene) needle in the anterior segment of the eye. Cataract formation behind the artificial iris is not an issue since it will hardly influence the patient's quality of vision. A sectorial artificial iris will not prevent dilation of the remaining iris provided the sphincter is intact, as it was in the case in our article. I do agree that I would not have performed this sequence of surgery if the remaining iris had not had an intact sphincter. I would have followed the proposal of Drs. Snyder and Perez and performed the cataract surgery first and then repaired the iris in the same surgical procedure. I am not too concerned about the possible resorption of the polypropylene over time. The iris is a very reactive tissue and will cover the artificial iris with a thin layer of fibrotic tissue to encapsulate this foreign body. It might influence the color slightly but not the stability of this tissue within the patient's eye. However, I do appreciate the comments that allow me to add the precision that was lacking in the original article: The use of polypropylene 10-0 will probably not jeopardize the stability of the iris prosthesis over time because of the particularly strong healing properties of the iris.dMarie-Jose B.R. Tassignon, PhD, MD
Ethical responsibility to disclose surgical errors Lau and Chan1 began their recent case report of incorrect intraocular lens (IOL) implantation with a review of content summary from 3 respected journals and the conclusion that “patients' needs and safety and ethical issues are not of high concern even though these areas are important in providing quality service and enhancing institutions' reputations.” Yet, although the patient described in their case report
2209
had subsequent IOL exchange surgery, “the truth of the surgical error remained undisclosed to the patient throughout the recovery period.” The incorrect IOL insertion crisis management protocol presented fails to address the ethical responsibility of the surgeon to disclose surgical error. There is consensus among professional societies, ethicists, and the general public that physicians are obligated to disclose medical errors that cause adverse effects to patients.2 The American Medical Association's Code of Medical Ethics3 states that “it is a fundamental ethical requirement that a physician should at all times deal honestly and openly with patients. Patients have a right to know their past and present medical status and be free of any mistaken beliefs concerning their conditions. Situations occasionally occur in which a patient suffers significant medical complications that may have resulted from the physician's mistake or judgment. In these situations, the physician is ethically required to inform the patient of all the facts necessary to ensure understanding of what has occurred. Only through full disclosure is a patient able to make informed decisions regarding future medical care.” Without disclosure to the patient, how can the patient make an informed choice to proceed with IOL exchange (versus alternative options, including seeking a second opinion)? Patients and family members want providers to explain what happened when adverse events occur, to express caring for the patient, and to feel remorse.4 Full disclosure leads to greater trust and more positive regard, particularly when the physician acknowledges responsibility and apologizes for the adverse event. Full disclosure and acceptance of responsibility do not appear to increase intention to sue.2 While prevention of incorrect IOL surgery using the “5 rights” (right patient, right site, right procedure, right model, right IOL power)1 is a laudable goal, when things do go astray one should not forget the patient's rights. Preston H. Blomquist, MD Dallas, Texas, USA
REFERENCES 1. Lau KY, Chan ZCY. Crisis management after incorrect intraocular lens insertion. J Cataract Refract Surg 2012; 38:1499–1501 2. Wu AW, Huang I-C, Stokes S, Pronovost PJ. Disclosing medical errors to patients: it’s not what you say, it’s what they hear. J Gen Intern Med 2009; 24:1012–1017. Available at: http:// www.ncbi.nlm.nih.gov/pmc/articles/PMC2726881/pdf/11606_ 2009_Article_1044.pdf. Accessed September 14, 2012 3. American Medical Association Code of Medical Ethics, Opinion 8.12-Patient Information. Issued March 1981, updated June 1994. Available at: http://www.ama-assn.org/ama/pub/ physician-resources/medical-ethics/code-medical-ethics/opinion 812.page? Accessed September 14, 2012
J CATARACT REFRACT SURG - VOL 38, DECEMBER 2012