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Endophthalmitis rates after implantation of the intraocular collamer lens: survey of users between 1998 and 2006

Bruce D. Allan, MD, Isabel Argeles-Sabate, DO, Nick Mamalis, MD An anonymous on-line survey was sent to 234 intraocular Collamer lens (ICL) (Staar Surgical)surgeons in 21 countries to determine how many of their ICL cases had been complicated by endoph-thalmitis between January 1998 and December 2006. A second questionnaire about the infectiondetails and treatment outcome was sent to those who reported cases of endophthalmitis. Ninety-five (40%) surgeons responded to the survey. They had implanted 17954 ICLs during the studyperiod. Three surgeons reported 1 case of endophthalmitis each, a rate of 0.0167% (95%) confi-dence interval 0 to 0.036%) or approximately 1 case of endophthalmitis per 6000 ICL implantations.
Follow-up details were available in 2 cases. Staphylococcus epidermidis was cultured in both cases,and both were treated without loss of vision. Endophthalmitis may be less common after ICL implan-tation than after cataract surgery. Further studies are required to define the rate and prognosis forendophthalmitis after ICL implantation to assist in accurate preoperative patient counseling.
J Cataract Refract Surg 2009; 35:766–769 Q 2009 ASCRS and ESCRS The intraocular Collamer lens (ICL) (Staar Surgical) is The risk for permanent visual loss associated with a posterior chamber phakic intraocular lens (pIOL) surgery is an important facet of preoperative counsel- made of a proprietary, flexible, synthetically cross- ing before any intraocular procedure. Risk estimates linked collagen polymeric (Collamer) material. The are based on a variety of possible mechanisms for IOL is placed in the sulcus through a 3.0 mm self-seal- visual losbut intraocular infection rates are a key con- ing incision. Previous studies show that the ICL has sideration. There has been no attempt to derive a repre- a good safety profile and effectively corrects myopia, sentative figure for the rate of endophthalmitis after myopic astigmatism, and hypermetropia.
pIOL implantation, and patient counseling on this as-pect of risk before ICL implantation is largely basedon contemporary data for endophthalmitis rates aftercataract surgery. These figures may overestimate or un-derestimate the risk associated with ICL implantation.
As an exclusive supplier, Staar Surgical has accurate data on the number of ICLs supplied to each operating From Moorfields Eye Hospital (Allan), London, United Kingdom; surgeon. Using this data and an anonymous Internet- Staar Surgical (Argeles-Sabate), Monrovia, California; and the based questionnaire survey, we attempted to derive John A. Moran Eye Center (Mamalis), Salt Lake City, Utah, USA.
a representative figures for the rate of endophthalmitis Isabel Argeles-Sabate is the international medical advisor for Staar after ICL implantation based on the number of ICLs Surgical. No other author has a financial or proprietary interest in implanted by each surgeon surveyed and the number of cases complicated by endophthalmitis within a de-fined study period (January 1998 to December 2006).
Presented in part at the XXVI Congress of the European Society ofCataract and Refractive Surgeons, Berlin, Germany, September2008.
Supported by an unrestricted grant from Staar Surgical, Monrovia, The study protocol was reviewed by the Research Gover- nance Committee at Moorfields Eye Hospital, London,United Kingdom. The survey was conducted in 21 countries Corresponding author: Bruce Allan, MD, Moorfields Eye Hospital, in which regional distributors had accurate records of cur- City Road, London EC1V 2PD, United Kingdom. E-mail: rent e-mail contacts for all ICL surgeons active in the study period (January 1998 to December 2006) and the number of SPECIAL REPORT: ENDOPHTHALMITIS AFTER ICL IMPLANTATION ICLs each had implanted. Surgeons in the United States werenot included as the ICL was not approved by the U.S. Food and Drug Administration and therefore not marketed in the Two hundred thirty-four surgeons were contacted by e-mail with log-in details and a hyperlink to a secure Internet site. Questionnaire items and instructions were available inEnglish, French, German, Italian, Korean, and Spanish on the Internet site. Surgeons failing to respond to the initial e-mail invitation were contacted each month for 2 months (up to a total of 3 times). The e-mail invitation stated that data recorded by responding surgeons would be used inan anonymous pooled analysis only and that no compari-sons between centers would be performed.
surgeons completed a follow-up questionnaire. In both Main outcome measures were the number of ICL cases of their cases, aqueous cultures were positive for Staphy- performed in the study period and the number of endoph-thalmitis cases reported. Data on the number of ICLs im- lococcus epidermitis. (Vitreous cultures were not per- planted were derived from distributors’ records and formed.) Surgery had been uneventful, and infection corroborated by figures for ICLs supplied to each distributor presented early in the postoperative course (1 case on by Staar Surgical during the study period. The number of en- day 3 and 1 on day 4). Treatment with intraocular and dophthalmitis cases was derived from questionnaire re- systemic antibiotic agents resulted in resolution of in- Endophthalmitis was defined as intraocular inflammation flammation with no loss in the preoperative best cor- accompanied by pain, blurring, and a hypopyon occurring rected visual acuity. The ICL was left in situ in both between 24 hours and 2 weeks after surgery. This time win- cases, and both had uneventful ICL implantation in the dow was selected to avoid crossover with toxic anterior seg- ment Responding surgeons were asked to record Antibiotic prophylaxis preferences varied widely the number of cases of endophthalmitis occurring in ICL pa-tients during the study period using a forced-choice drop- (), with 43% of surgeons using no systemic, periocular, or intraocular antibiotic drugs periopera- The initial questionnaire also asked surgeons reporting tively. Most surgeons operated in a private hospital cases of endophthalmitis to tick a box if they were willing (48%) or an ambulatory surgery center (39%) rather to be contacted with a follow-up questionnaire addressing than a public hospital setting (13%).
details of the investigation, treatment, and outcome of theendophthalmitis cases. A review of case notes was not re-quired for the initial questionnaire, but follow-up question-naires were completed with reference to case notes.
The initial questionnaire contained 2 items addressing Table 2. Breakdown of responses by country.
perioperative antimicrobial prophylaxis preferencesandthe surgical setting. Surgeons were asked to check boxes to indicate whether their routine ICL surgery practice included preoperative topical antibiotic agents, perioperative oralantibiotic agents, preoperative topical povidone–iodine, intracameral cefuroxime, subconjunctival cefuroxime, and postoperative topical antibiotic agents. Surgeons were also asked to indicate the most commonly used surgical setting for their ICL implantation procedures using a forced-choice drop-down menu; the options were public hospital, private hospital, and ambulatory surgery center.
Of the 234 surgeons invited to participate, 95 answered the first survey, a 40% response rate. The 95 respon- dents had implanted 17 954 ICLs during the study pe- riod, approximately 50% of the total number of ICLs Three surgeons in 3 countries reported 1 case of endophthalmitis each, giving a crude rate of endoph- thalmitis after ICL implantation of 3/17 954 or approx- imately 1 case of endophthalmitis per 6000 ICLs implanted (0.0167%; 95% confidence interval, 0-0.0356%or up to 1 case per 2800 ICLs implanted). Two of the 3 J CATARACT REFRACT SURG - VOL 35, APRIL 2009 SPECIAL REPORT: ENDOPHTHALMITIS AFTER ICL IMPLANTATION multicenter studies in which a prospective reporting system is used to monitor changes in endophthalmitis rates over time,and surveys of large samples.All rely on accurate diagnosis and reporting of endoph- thalmitis casSingle-center studies and random- ized trials may have more robust case reporting systemsbut tend to have a smaller sample size and therefore wider confidence intervals around the Intraocular Collamer lens implantation is far less Figure 1. Methods of antibacterial prophylaxis used routinely in ICL commonly performed than cataract surgery. A large implantation by responding surgeons (ICL Z intraocular Collamerlens).
multicenter study is therefore the only practical meansof obtaining a sample size large enough to generatea meaningful estimate of the endophthalmitis rate.
Our study addresses 2 important disincentives to ac- The data presented are the first attempt to derive a rep- curate reporting. First, respondents were reassured resentative figure for the rate of endophthalmitis after that data from their clinics would be used in pooled ICL implantation independent of rates for other intra- analyses only, not to compare outcomes between com- ocular procedures, cataract surgery in particular. The peting centers. Second, the survey was quick to com- crude rate of 1 case per 6000 implantations is less plete, electronic, and did not require reference to case than that reported in large-scale contemporary studies notes. Prospective reporting systems, including regis- of endophthalmitis after cataract surgery (.
try studies, often require reference to case notes; the However, caution is required in the interpretation. The availability, completion, and submission of paper methodology we describe requires participating sur- forms for data collection; and considerable time invest- geons to remember cases of endophthalmitis and to ment for the responding surgeon. Serious ocular in- respond to a survey accurately. Endophthalmitis is flammation is rare after ICL implantation, and most a sufficiently rare event in intraocular surgery that implantations are carried out in a private setting even with a relatively large sample, failure to report with good continuity of care. Both these factors should a small number of cases accurately would make a sig- ensure accurate negative responses to the primary nificant difference to the crude rate derived.
Methods used to derive contemporary figures for A detailed follow-up questionnaire was sent to the 3 the endophthalmitis rate after cataract surgery surgeons who reported cases of presumed endoph- include large-scale randomized trisingle and thalmitis. In addition to collecting visual outcomedata, the questionnaire was designed to ensurea good fit between cases reported and the definition of endophthalmitis used. Two surgeons respondedto the follow-up questionnaire. Both of their cases were culture positive and had a good visual outcome.
Most studies of endophthalmitis rates also include cul- ture-negative cases within set criteria.We are unableto comment on the status of the case for which the follow-up questionnaire was not completed, but thiscase was included in the rate calculation to avoid Despite the relative ease of responding to a brief electronic questionnaire and 3 e-mail reminders, only40% of surgeons responded to the primary survey. Ac- curate records were available to define the number of ICLs implanted by each of the surgeons surveyed, and the respondents accounted for approximately 50% ofall ICLs implanted in the study period. The 40% re- Figure 2. The endophthalmitis rate (%) after ICL implantation com- sponse rate, while suboptimal, compares well with pared with the rates derived from a selection of studies of endoph- 18.0% and 15.5% response rates in recent American So- thalmitis after cataract surgery.Error bars represent 95%confidence intervals (ESCRS ciety of Cataract and Refractive Surgery electronic Refractive Surgeons; ICL Z intraocular Collamer lens).
J CATARACT REFRACT SURG - VOL 35, APRIL 2009 SPECIAL REPORT: ENDOPHTHALMITIS AFTER ICL IMPLANTATION Anonymous pooled analysis of data should have 9. Lundstro¨m M, Wejde G, Stenevi U, Thorburn W, Montan P. En- acted to avoid conflict of interest for surgeons report- dophthalmitis after cataract surgery; a nationwide prospectivestudy evaluating incidence in relation to incision type and loca- ing cases of endophthalmitis, minimizing selection 10. West ES, Behrens A, McDonnell PJ, Tielsch JM, Schein OD.
Staar Surgical operates a prospective worldwide re- The incidence of endophthalmitis after cataract surgery among porting system for recording adverse incidents, includ- the U.S. Medicare population increased between 1994 and ing endophthalmitis. To date, of 125000 ICLs implanted 2001. Ophthalmology 2005; 112:1388–1394 11. Mollan SP, Gao A, Lockwood A, Durrani OM, Butler L. Postca- since 1993, 6 cases of endophthalmitis have been re- taract endophthalmitis: incidence and microbial isolates in ported. Taken together with our survey data, this a United Kingdom region from 1996 through 2004. J Cataract would indicate that endophthalmitis may be less com- Refract Surg 2007; 33:265–268; erratum, 759 mon after ICL surgery than after cataract surgery. Al- 12. Taban M, Behrens A, Newcomb RL, Nobe MY, Saedi G, though ICL surgery is commonly performed under Sweet PM, McDonnell PJ. Acute endophthalmitis following cat-aract surgery; a systematic review of the literature. Arch Oph- topical anesthesia through a temporal clear corneal in- cisiondboth possible risk factors for endophthalmitis 13. Oshika T, Hatano H, Kuwayama Y, Ogura Y, Ohashi Y, Oki K, in cataract surgerydand antimicrobial prophy- Uno T, Usui N, Yoshitomi F. Incidence of endophthalmitis after cat- laxis preferences varied widely among the surgeons aract surgery in Japan. Acta Ophthalmol Scand 2007; 85:848–851 surveyed, the surgery is relatively fast and noninvasive.
14. ESCRS Endophthalmitis Study Group. Prophylaxis of postoper- ative endophthalmitis following cataract surgery: results of the In particular, there is no contact with the vitreous. Both ESCRS multicenter study and identification of risk factors. J Cat- vitreous loss in cataract surgerand vitrectare associated with a higher rate of endophthalmitis than 15. Nagaki Y, Hayasaka S, Kadoi C, Matsumoto M, Yanagisawa S, Watanabe K, Watanabe K, Hayasaka Y, Ikeda N, Sato S, Endophthalmitis may be less common after ICL im- Kataoka Y, Togashi M, Abe T. Bacterial endophthalmitis aftersmall-incision cataract surgery; effect of incision placement and plantation than after cataract surgery. Further studies intraocular lens type. J Cataract Refract Surg 2003; 29:20–26 are required to define the rate and prognosis for en- 16. Ng JQ, Morlet N, Bulsara MK, Semmens JB. Reducing the risk dophthalmitis after ICL implantation to assist in accu- for endophthalmitis after cataract surgery: population-based rate preoperative patient counseling.
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