Reply
2
Lastly, it does not appear clear as to why the authors labeled their study as retrospective in nature if they even performed an earlier pilot study in 2009. VASILIKI ZYGOURA NIKOLAOS KOPSACHILIS GIANLUCA CARIFI London, United Kingdom THE AUTHORS HAVE COMPLETED AND SUBMITTED THE ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. The authors indicate no funding support. REFERENCES 1. Vollman DE, Gonzalez-Gonzalez LA, Chomsky A, Daly MK, Baze E, Lawrence M. Intraoperative floppy iris and prevalence of intraoperative complications: results from ophthalmic sur- gery outcomes database. Am J Ophthalmol 2014;157(6): 1130–1135. 2. Jaycock P, Johnston RL, Taylor H, et al; UK EPR user group. The Cataract National Dataset electronic multi-centre audit of 55,567 operations: updating benchmark standards of care in the United Kingdom and internationally. Eye 2009;23(1): 38–49. 3. Marques FF, Marques DM, Osher RH, Osher JM. Fate of ante- rior capsule tears during cataract surgery. J Cataract Refract Surg 2006;32(10):1638–1642. 4. Johnston RL, Taylor H, Smith R, Sparrow JM. The Cataract National Dataset electronic multi-centre audit of 55,567 oper- ations: variation in posterior capsule rupture rates between sur- geons. Eye 2010;24(5):888–893. REPLY WE GREATLY APPRECIATE THE INTEREST OF DRS ZYGOURA, Kopsachilis, and Carifi in our study 1 and are happy to address their comments below. First, regarding methodology, the original Ophthalmic Surgery Outcomes Database (OSOD) Pilot Project was a quality improvement program conducted by the Veterans Health Administration (VHA). This program reviewed preoperative, intraoperative, and postoperative informa- tion of patients undergoing cataract surgery at 5 VHA sites in the United States. Specific data elements, predeter- mined by the OSOD Committee, were abstracted from pre- operative, intraoperative, and postoperative records of eligible patients by nurse reviewers and entered into a database. After the quality improvement program was completed, the National Surgery Office within the VHA compiled the data generated by the OSOD into a data set devoid of any patient identifiers. With Institutional Review Board approval and a Data Use Agreement, the de-identified data set was analyzed for this retrospective study. Second, approximately 150 data elements were collected in the original OSOD. Intraoperative floppy iris syndrome (IFIS) was collected as a dichotomous variable (ie, present or not). It is not possible to determine from this data set the degree of IFIS (mild to complete), since this information was not included. The same applies for the phacoemulsifi- cation platform, incision size, type of irrigation/aspiration devices, and the ophthalmic viscosurgical device type used. Third, in accordance with Department of Veterans’ Affairs policy, an attending surgeon was present during all surgical procedures and many cases also involved a resi- dent surgeon. The de-identified data set did not include surgeon-specific information other than whether the major portions of the case were performed by an attending or a resident surgeon. Fourth, as demonstrated in Table 1 of the study, the overall prevalence of posterior capsule rupture was 4.1%; in patients with IFIS it was 6.9% and in patients without IFIS it was 3.7%. As discussed above, the OSOD included a wide variety of surgeons and is in line with posterior capsule tear rates at academic medical centers. 2–4 The overall prevalence of anterior capsule tears was 3.2%; in patients with IFIS it was 3.9% and in patients without IFIS it was 3.1%. These rates are similar to those published in peer-reviewed literature for cases at similar in- stitutions. 4 The commentators report complication rates for their institution that have not been published. We encourage them to submit such data for peer review and look forward to seeing it in the future literature. Fifth, the data set noted the use of pupil expansion devices, but not at which time these were employed during the surgery. In some cases, as the commentators suggest, pupil expansion devices are used for limited dilation and not necessarily for IFIS. Finally, our group is indeed examining several other spe- cific outcomes in the data set, of which cystoid macular edema is an example. Several of these other reviews have been presented at recent meetings and are being prepared for publication. DAVID E. VOLLMAN St Louis, Missouri LUIS A. GONZALEZ-GONZALEZ Jamaica Plain, Massachusetts AMY CHOMSKY Nashville, Tennessee MARY K. DALY Jamaica Plain, Massachusetts ELIZABETH BAZE Houston, Texas MARY G. LAWRENCE Bethesda, Maryland CONFLICT OF INTEREST DISCLOSURES: SEE THE ORIGINAL article for any disclosures of the authors. VOL. 158,NO. 4 847 CORRESPONDENCE
Transcript of Reply
Lastly, it does not appear clear as to why the authorslabeled their study as retrospective in nature if they evenperformed an earlier pilot study in 2009.
VASILIKI ZYGOURA
NIKOLAOS KOPSACHILIS
GIANLUCA CARIFI
London, United Kingdom
THE AUTHORS HAVE COMPLETED AND SUBMITTED THEICMJE Form for Disclosure of Potential Conflicts of Interest and nonewere reported. The authors indicate no funding support.
REFERENCES
1. Vollman DE, Gonzalez-Gonzalez LA, Chomsky A, Daly MK,Baze E, Lawrence M. Intraoperative floppy iris and prevalenceof intraoperative complications: results from ophthalmic sur-gery outcomes database. Am J Ophthalmol 2014;157(6):1130–1135.
2. Jaycock P, Johnston RL, Taylor H, et al; UK EPR user group.The Cataract National Dataset electronic multi-centre auditof 55,567 operations: updating benchmark standards of carein the United Kingdom and internationally. Eye 2009;23(1):38–49.
3. Marques FF, Marques DM, Osher RH, Osher JM. Fate of ante-rior capsule tears during cataract surgery. J Cataract Refract Surg2006;32(10):1638–1642.
4. Johnston RL, Taylor H, Smith R, Sparrow JM. The CataractNational Dataset electronic multi-centre audit of 55,567 oper-ations: variation in posterior capsule rupture rates between sur-geons. Eye 2010;24(5):888–893.
REPLY
WE GREATLY APPRECIATE THE INTEREST OF DRS ZYGOURA,
Kopsachilis, and Carifi in our study1 and are happy toaddress their comments below.
First, regarding methodology, the original OphthalmicSurgery Outcomes Database (OSOD) Pilot Project was aquality improvement program conducted by the VeteransHealth Administration (VHA). This program reviewedpreoperative, intraoperative, and postoperative informa-tion of patients undergoing cataract surgery at 5 VHA sitesin the United States. Specific data elements, predeter-mined by the OSODCommittee, were abstracted from pre-operative, intraoperative, and postoperative records ofeligible patients by nurse reviewers and entered into adatabase. After the quality improvement program wascompleted, the National Surgery Office within the VHAcompiled the data generated by the OSOD into a dataset devoid of any patient identifiers. With InstitutionalReview Board approval and a Data Use Agreement, thede-identified data set was analyzed for this retrospectivestudy.
VOL. 158, NO. 4 CORRESPON
Second, approximately 150 data elements were collectedin the original OSOD. Intraoperative floppy iris syndrome(IFIS) was collected as a dichotomous variable (ie, presentor not). It is not possible to determine from this data set thedegree of IFIS (mild to complete), since this informationwas not included. The same applies for the phacoemulsifi-cation platform, incision size, type of irrigation/aspirationdevices, and the ophthalmic viscosurgical device type used.Third, in accordance with Department of Veterans’
Affairs policy, an attending surgeon was present duringall surgical procedures and many cases also involved a resi-dent surgeon. The de-identified data set did not includesurgeon-specific information other than whether the majorportions of the case were performed by an attending or aresident surgeon.Fourth, as demonstrated in Table 1 of the study, the
overall prevalence of posterior capsule rupture was 4.1%;in patients with IFIS it was 6.9% and in patients withoutIFIS it was 3.7%. As discussed above, the OSOD includeda wide variety of surgeons and is in line with posteriorcapsule tear rates at academic medical centers.2–4 Theoverall prevalence of anterior capsule tears was 3.2%; inpatients with IFIS it was 3.9% and in patients withoutIFIS it was 3.1%. These rates are similar to thosepublished in peer-reviewed literature for cases at similar in-stitutions.4 The commentators report complication ratesfor their institution that have not been published. Weencourage them to submit such data for peer review andlook forward to seeing it in the future literature.Fifth, the data set noted the use of pupil expansion
devices, but not at which time these were employed duringthe surgery. In some cases, as the commentators suggest,pupil expansion devices are used for limited dilation andnot necessarily for IFIS.Finally, our group is indeed examining several other spe-
cific outcomes in the data set, of which cystoid macularedema is an example. Several of these other reviews havebeen presented at recent meetings and are being preparedfor publication.
DAVID E. VOLLMAN
St Louis, MissouriLUIS A. GONZALEZ-GONZALEZ
Jamaica Plain, MassachusettsAMY CHOMSKY
Nashville, TennesseeMARY K. DALY
Jamaica Plain, MassachusettsELIZABETH BAZE
Houston, TexasMARY G. LAWRENCE
Bethesda, Maryland
CONFLICT OF INTEREST DISCLOSURES: SEE THE ORIGINALarticle for any disclosures of the authors.
847DENCE
REFERENCES
1. Vollman D, Gonzalez-Gonzalez LA, Chomsky A, Daly M,Baze E, Lawrence M. Intraoperative floppy iris and prevalenceof intraoperative complications: results from ophthalmic sur-gery outcomes database. Am J Ophthalmol 2014;157(6):1130–1135.
2. Briszi A, Prahs P, Hillenkamp J, Helbig H, Herrmann W.Complication rate and risk factors for intraoperative complica-tions in resident-performed phacoemulsification surgery.Graefes Arch Clin Exp Ophthalmol 2012;250(9):1315–1320.
3. Blomquist PH, Morales ME, Tong L, Ahn C. Risk factors forvitreous complications in resident-performed phacoemulsifica-tion surgery. J Cataract Refract Surg 2012;38(2):208–214.
4. Hashemi H,MohammadpourM, JabbarvandM,Nezamdoost Z,Ghadimi H. Incidence of and risk factors for vitreous loss inresident-performed phacoemulsification surgery. J CataractRefract Surg 2013;39(9):1377–1382.
Intraoperative Floppy Iris andPrevalence of IntraoperativeComplications: Results FromOphthalmic Surgery OutcomesDatabase
EDITOR:
I READ THEWITH INTEREST THE ARTICLE BY VOLLMAN AND
associates,1 which reports a lot of important new data onintraoperative floppy iris syndrome (IFIS) incidence andcomplication rates. This is particularly important sincethe rate of IFIS complications is very controversial andthe exact data on the type and prevalence of intraoperativecomplications is missing in available literature, as wasshown in our paper.2 Moreover, the recent study by Changand associates reported no complications in IFIS in bothalpha-agonist and non-alpha-agonist patients.3
The very original result of the study is the relatively highrate of IFIS occurrence in non-alpha-antagonist patients(24.8%), more than described in previous studies: from0.61%4 to 12%–14%.3
The authors, however, did not present the rate of com-plications in 3 IFIS subgroups: selective alpha blockers,nonselective alpha blockers, and non–alpha blockers.They pooled all IFIS complications into 1 category andcompared it to non-IFIS complication rates. More dataon nature and rate of specific complications in each of thesesubgroups would enable us to better understand the compli-cation risks, especially in the non–alpha blockers group.
The authors also mentioned that pupillary expansiondevices, such as the Malyugin ring, were shown to effec-tively manage IFIS. This is, however, a quite controversialissue. They referenced the study by Chang,5 in which 50%of the cases had iris prolapse in spite of Malyugin ring use. Itis believed that pupil expansion devices dilate the pupil at
848 AMERICAN JOURNAL OF
the margin but do not stabilize the iris, especially at themidperiphery. On the other hand, several papers showthe benefits of using iris retractors in IFIS, including dia-mond configuration or a single sub-incisional retractor, asthey act as a physical barrier to the prolapsing iris.6
ANDRZEJ GRZYBOWSKI
Department of Ophthalmology, University of Warmia andMazury, Olsztyn, Poland
THE AUTHOR HAS COMPLETED AND SUBMITTED THE ICMJEForm for Disclosure of Potential Conflicts of Interest and none werereported. The author indicates no funding support.
REFERENCES
1. Vollman DE, Gonzales-Gonzales LA, Chomsky A, Daly MK,Baze E, Lawrence M. Intraoperative floppy iris and prevalenceof intraoperative complications: results fromOphthalmicSurgeryOutcomes Database. Am J Ophthalmol 2014;157(6):1130–1135.
2. Grzybowski A, Krzy_zanowska-Berkowska P. Intraoperativefloppy iris syndrome (IFIS): what complication rates can weexpect? Graefes Clin Exp Ophthalmol 2014;252(5):845–846.
3. Chang DF, Campbell JR, Colin J, Scheitzer C. Prospectivemasked comparison of intraoperative floppy iris syndromeseverity with tamsulosin versus aluzosin. Ophthalmology 2014;121(4):829–834.
4. Haridas A, Syrimi M, Al-Ahmar B, Hingorani M. Intraopera-tive floppy iris syndrome (IFIS) in patients receiving tamsulo-sin or doxazosin - a UK-based comparison of incidence andcomplication rates. Graefes Arch Clin Exp Ophthalmol 2013;251(6):1541–1545.
5. Chang DF. Use of Malyugin pupil expansion device for intra-operative floppy-iris syndrome: results in 30 consecutive cases.J Cataract Refract Surg 2008;34(5):835–841.
6. Tint NL, Dhillon AS, Alexander P. Management of intraoper-ative iris prolapse: stepwise practical approach. J Cataract
Refract Surg 2012;38(10):1845–1852.
REPLY
WEGREATLYAPPRECIATE THE INTERESTOFDRGRZYBOWSKI
in our study1 and are happy to address his comments below.Our study reports the prevalence of intraoperative floppy
iris syndrome (IFIS) and the use or not of alpha-antagonistin the Veterans’ Health Administration population asrecorded by the Ophthalmic Surgery Outcomes Database.Given the methodology of the study, estimation of inci-dence rates is not possible. We reported the prevalence ofmedication use in our population, which is very particular.As mentioned in our study, a limitation of the OphthalmicSurgery Outcomes Database is the potential selection biasinherent in patients who receive care at the VeteransHealth Administration, since the population is predomi-nantly male and male patients use alpha-antagonists at amuch higher rate than female patients.
OCTOBER 2014OPHTHALMOLOGY
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