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Clinical Sciences |

Wound Complications Following Cataract Surgery:  A Case-Control Study FREE

Jorge L. Arango, MD; Curtis E. Margo, MD, MPH
[+] Author Affiliations

From the Section of Ophthalmology, James A. Haley Veterans Hospital, Tampa, Fla, and the Department of Ophthalmology, University of South Florida, College of Medicine, Tampa.


Arch Ophthalmol. 1998;116(8):1021-1024. doi:10.1001/archopht.116.8.1021.
Text Size: A A A
Published online

Objective  To determine whether selected preoperative medical, social, or behavioral factors predict the occurrence of cataract wound complications.

Patients and Methods  Patients who underwent cataract surgery at a Veterans Administration hospital were used in a case-control study. Cases were defined by the occurrence of any postoperative cataract wound gape with or without iris prolapse within 12 weeks of surgery and requiring repair in the operating room. Controls were patients who had no postoperative complications. Two controls were selected for each case patient and matched for surgeon.

Results  Thirty-one patients with postoperative wound complications occurred after 2041 cataract extractions (1.5%). Occurrence of wound complications was predicted by previous hematologic disorder (odds ratio, 2.9; 95% confidence interval, 1.1-8.1). Phacoemulsification surgery had a protective effect against wound complication (odds ratio, 0.2; 95% confidence interval, 0.09-0.64). There was no difference in final visual acuity and refractive indexes in patients with and without wound complications (P=.6 by Student t test).

Conclusions  Most medical, social, and behavioral preoperative factors have limited discriminatory power in predicting who will have postoperative cataract wound complications. The association of previous hematologic disorders to predict the occurrence of wound complications varied with the level of alcohol use. Although this study was not primarily designed to assess the role of surgical technique, phacoemulsification cataract extraction had a statistically significant protective effect against wound complications. Visual outcome in patients with postoperative wound complications is generally very good.

CATARACT extraction with implantation of an intraocular lens is the most common and most successful surgical procedure performed in the United States.1 The vast majority of cataract extractions are uncomplicated surgical procedures that have a favorable outcome. Current methods of measuring outcome include visual acuity, VF-14 score (a measure of functional impairment related to vision), and patient satisfaction surveys.2,3 More than 93% of patients without known preoperative ocular comorbidities have improved visual acuity of 20/40 or better,4 89% to 92% have improved VF-14 scores postoperatively,3 and more than 85% are satisfied with their postoperative vision following cataract surgery.4,5

Lack of improvement of 1 or more of these outcome measures has been strongly associated with postoperative complications, including astigmatism, bullous keratopathy, intraocular lens malposition or dislocation, wound gape, iris prolapse, ocular trauma, endophthalmitis, cystoid macular edema, retinal detachment, or chronic uveitis.2,46

Little information is available in the medical literature concerning the medical, behavioral, and social factors that predict postoperative wound complications. The paucity of information is partly due to the low frequency of wound complications. The rate of wound gape or iris prolapse with cataract extraction is low, ranging from 0% to 1.6% with phacoemulsification710 and from 0% to 3.0% with extracapsular cataract extraction.1123

We performed a case-control study to determine whether selected preoperative factors predict patients who are prone to develop postoperative cataract wound gape with or without iris prolapse.

Patients with postoperative wound complications were identified from the surgical registry of the James A. Haley Veterans Hospital, Tampa, Fla, from October 1, 1988, through December 31, 1996. A postoperative wound complication was defined as any abnormal gaping of the cataract wound with or without iris prolapse occurring within 12 weeks of surgery that was serious enough to necessitate surgical repair in the operating room. Cataract surgery was defined as the elective removal of the crystalline lens and/or the implantation of an artificial lens for the purposes of improving visual function. The extracapsular techniques used included manual nuclear expression and removal of the lens nucleus as well as phacoemulsification. Patients with cataracts removed during corneal transplantation and glaucoma filtration surgery, primary posterior segment surgery, and surgical repair of ocular trauma were excluded.

Control patients were randomly selected from the same surgical registry and matched for resident surgeon. Two controls were selected for each case patient. The dates of surgery for case and control patients did not usually exceed 3 months. Ten percent of medical records were abstracted a second time in a masked fashion to measure intraobserver and interobserver agreement.

Medical records of case patients and control patients were reviewed for the following preoperative medical, social, and behavioral factors: general medical and ocular comorbidities, number of medications, history of smoking and alcohol intake, preoperative visual acuity, and visual acuity of untreated eye. The presence or absence of the following medical conditions were recorded: cardiac dysrhythmia (excluding first-degree atrioventricular block and sinus arrhythmia), "clinically significant" rheumatologic disorder, hematologic disorder, neurologic or psychiatric disorder, cardiac disorder, previous fall requiring medical treatment, and previous accidental injury requiring hospitalization. Criteria used to determine "clinically significant" medical conditions included referral to a specialist for care, hospitalization for the condition, or a condition requiring 3 or more outpatient visits for management. Living condition was recorded as sheltered, homeless, or unknown. Intraoperative complications, the time of final refraction, final refractive error, and final visual acuity were recorded.

Visual acuity scores were converted to log of the minimum angle of resolution (logMAR) for nonparametric statistical analysis. Each off-the-chart score (ie, visual acuity <20/400) was assigned a value of 0.3 logMAR so that counting fingers at 19 to 10 ft (5.7-3.0 m) was 1.6 logMAR; counting fingers at 9 to 1 ft (270-30 cm), 1.9 logMAR; hand motion, 2.2 logMAR; and light perception, 2.5 logMAR. Alcohol use and smoking, if active within the last year, were each graded on a scale of 1 to 3 with 1 indicating no use; 2, less than 6 beers (72 oz) per day (or equivalent distilled alcohol) or less than 1 pack of cigarettes per day; and 3, greater than level 2 amounts.

Patient characteristics and outcome measures were examined using contingency tables and relative risk estimated for matched data with 2 controls per case.24,25 Stratified analysis was analyzed using the methods of Mantel-Haenszel.26 For the purposes of stratified analysis, preoperative visual acuity of the eye that was operated on and that of the other eye was divided into 2 strata at 0.7 logMAR. The 2-tailed Student t test and Wilcoxon signed rank test were used to examine the null hypothesis that the population sample mean difference is zero. Test selection depended on assumptions about the normality of the population distribution. Univariate logistic regression and multivariate conditional and nonconditional logistic regression were performed to analyze the relationship between preoperative patient characteristics and outcome.27 Frequency matched data (ie, year of resident training) was used for nonconditional logistic regression models. Stepwise model building techniques using repeated application of selection-deletion modification were used.28 The postoperative cataract wound status was the dependent variable and the preoperative clinical and social factors were independent variables. If the stratified analysis indicated that the association between a potential risk factor and risk of wound complication was modified by another risk factor, a test was performed to determine whether this interaction was statistically significant in a multiple logistic regression model. This was accomplished by first multiplying the 2 risk factor terms to create a first-order interaction term. A likelihood ratio statistic test was then performed to determine whether this product term was a significant predictor of wound complication.29

This study was approved by the Hospital Institutional Review Board.

Thirty-one patients with postoperative wound complications were identified from a total of 2041 elective cataract extraction procedures (1.5%). Twenty-nine patient charts were available for review. The clinical indication for surgical repair of the cataract wound was documented by an attending physician in each case. The medical records of 58 surgeon-matched control patients were reviewed. Retrobulbar or peribulbar anesthesia was used in all cases. Each primary cataract surgery and wound repair was supervised by an attending physician. Preoperative patient characteristics for case and control patients are presented in Table 1. There were no differences in preoperative ocular comorbidities in the eye that was operated on between cases and controls. A single preoperative factor was predictive of outcome: previous hematologic disorder (odds ratio, 2.9; 95% confidence interval, 1.1-8.1). This association was found with logistic regression analysis and Mantel-Haenszel test using matched analysis. The different types of hematologic disorders in case patients are listed below (some patients had more than 1 hematologic disorder).

Table Graphic Jump LocationTable 1. Preoperative Patient Characteristics*

The relative risk of wound complication associated with hematologic disorder varied with the level of alcohol use (Table 2). The likelihood ratio statistic test indicated that there was a trend toward interaction between the presence of hematologic disease and alcohol consumption (P=.08).

Table Graphic Jump LocationTable 2. Risk of Wound Complication Associated With Hematologic Disorder, by Alcohol Use

The median time to surgical repair for cataract wound gape or iris prolapse was 12 days (mean, 14.8 days; range, 1-48 days). Five wound repairs followed 950 phacoemulsification cataract extractions (0.5%) and 24 repairs followed 1125 extracapsular cataract extractions (2.1%). The odds ratio of postoperative wound complication for phacoemulsification cataract extraction compared with extracapsular cataract extraction was 0.2 (95% confidence interval, 0.09-0.6). There was no significant change in odds ratio when the type of surgery was adjusted for other factors, including year of resident training.

Final visual acuity and final refraction (spherical equivalent and cylinder) after wound repair in the case patients were not statistically different from those of control patients (Table 3).

Table Graphic Jump LocationTable 3. Operative Findings and Postoperative Results

The overall proportion of 1.4% wound complications in this study falls within the 0% to 3.0% range reported in the literature.823 When the results were examined according to type of surgery, however, phacoemulsification extraction displayed a 5-fold protective effect relative to extracapsular cataract extraction, a finding that was statistically significant. Although not a primary outcome measure of this study, the difference in risk between extraction methods adds considerable support to the theory that a small-incision phacoemulsification wound is structurally more secure than the larger incision with standard extracapsular cataract extraction.

The preoperative risk factors in this study were selected because of their potential to discriminate among patients who are prone to fall, live in a high-risk environment for injury, or may lack insight or resources for following postoperative instructions. Analysis of these factors revealed a history of previously diagnosed hematologic disorder predictive of postoperative wound complications. A variety of other medical, social, and behavorial factors had no predictive power in this setting. The association of hematologic disorder and wound complication varied with the level of alcohol use, with the greatest risk occurring in patients with the greatest alcohol consumption. Effect modification exists when the association between exposure (ie, hematologic disease) and outcome (ie, wound complication) varies by levels of a third factor (ie, alcohol use). Detection of effect modification usually requires a sample size several times larger than that required to detect the main effect.29 Despite our small sample size, the interaction between hematologic disease and alcohol consumption was statistically significant at the 0.1 level. We suspect that heavy alcohol use with hematologic disease identifies a high-risk group of patients with complex medical and social or behavioral problems. The general lack of association between other types of past medical problems and wound complications probably reflects the overall safety of cataract surgery for patients with less complex disease processes. It is possible that smaller statistically significant associations may exist, but cannot be identified in a case-controlled study with only 29 case patients.

An important source of bias in a case-control study is unequal exposure of cases and controls to a variable linked to outcome.30 In our study, differences in resident surgeon skill could have been such a factor. To effectively eliminate this potential confounder, cases and controls were matched by surgeon. Since matching can also introduce confounding as well as control for it, no other variables were matched.31 It is unlikely in this particular study, however, that an important preoperative patient-related confounder could be introduced when matching for surgeon.

A second source of bias in retrospective case-control studies is unequal surveillance of cases and controls.30 The so-called exposures in this study were major medical, social, and behavioral conditions that can be easily identified through a routine medical history taking. Because the majority of patients in this study were elderly and used a veterans hospital for primary care, most histories and physical examinations were performed by the medical service. All exposure data were completed before the outcome event had occurred, which reduces observer bias. Criteria used to identify "clinically significant" were kept simple and are unlikely to be overlooked by their very nature.

How generalizable are the results of this study? Surgical procedures were performed by residents, but the results are probably applicable to the clinical setting beyond formal training. The study was designed to analyze patient-related risk factors. Potential confounding variables related to surgeon and the introduction of "new" techniques were minimized by matching for surgeon and keeping dates of procedures on case and control patients within 3 months of one another. Studies dealing with faculty-supervised cataract extraction performed by residents have shown that the visual results are very good for both standard extracapsular and phacoemulsification techniques.23,32,33 Visual acuity results have exceeded the standard used for premarket approval application for intraocular lens implants to the US Food and Drug Administration.34 The patients in this study were mostly elderly white men (median age, 67 years) with a high proportion of general medical problems. The high prevalance of medical and social problems in this population of patients makes them an effective population to test our study hypothesis. We believe that our results apply to a healthier population of patients, but because most patients were white men, these results may not be as applicable to women and blacks.

Accepted for publication April 24, 1998.

Corresponding author: Curtis E. Margo, MD, MPH, Department of Ophthalmology, Watson Clinic, 1600 Lakeland Hills Blvd, Lakeland, FL 33805.

Schein  ODSteinberg  EPJavitt  JC  et al.  Variation in cataract surgery practice and clinical outcomes. Ophthalmology. 1994;1011142- 1152
Link to Article
Cataract Management Guideline Panel, Management of functional impairment due to cataract in adults [Appendix K. Literature review: surgical techniques and complications]. Ophthalmology. 1993;100(suppl)212S- 253S
Link to Article
Steinberg  EPTielsch  JMSchein  OD  et al.  The VF-14: an index of function impairment in patients with cataract. Arch Ophthalmol. 1994;112630- 638
Link to Article
Steinberg  EPTielsch  JMSchein  OD  et al.  National study of cataract surgery outcomes: variation in 4-month postoperative outcomes as reflected in multiple outcome measure. Ophthalmology. 1994;1001131- 1141
Link to Article
Schein  ODSteinberg  EPCassard  SC  et al.  Predictors of outcome in patients who underwent cataract surgery. Ophthalmology. 1995;102817- 823
Link to Article
Drolsum  LHaaskjold  E Causes of decreased visual acuity after cataract extraction. J Cataract Refract Surg. 1995;2159- 63
Link to Article
Sheets  JH A step beyond ECCE. CLAO J. 1987;1367- 70
Heslin  KBGuerriero  PN Clinical retrospective study comparing planned extracapsular cataract extraction and phacoemulsification with and without lens implantation. Ann Ophthalmol. 1984;16956- 962
Steinert  RFBrint  SFWhite  SMFine  IH Astigmatism after small incision cataract surgery: a prospective, randomized, multicenter comparison of 4 and 6.5 incision. Ophthalmology. 1991;98417- 424
Link to Article
Kratz  RPDavidson  BMazzocco  TRColvard  DM The Shearing intraocular lens: a report of 1,000 cases. J Am Intraocul Implant Soc. 1981;755- 57
Link to Article
Cunliffe  IAFlanagan  DWGeorge  NDAggarwaal  RJMoore  AT Extracapsular cataract surgery with lens implantation in diabetes with and without proliferative retinopathy. Br J Ophthalmol. 1990;759- 12
Link to Article
Watts  J Retrospective comparison of lens implant surgery and cataract surgery in a provincial unit. Br J Ophthalmol. 1986;70415- 417
Link to Article
Allen  AWZhang  HR Extracapsular cataract extraction: prognosis and complication with and without posterior chamber lens implantations. Ann Ophthalmol. 1987;19329- 333
Azen  SPHurt  ASteel  D  et al.  Effects of the Shearing posterior chamber intraocular lens on the corneal endothelium. Am J Ophthalmol. 1983;95798- 802
Link to Article
Kooner  KSDulaney  DDZimmerman  TJ Intraocular pressure following extracapsular cataract extraction and posterior lens implantation. Ophthalmic Surg. 1988;19471- 474
Liesegang  TJBourne  WMIlstrup  DM Prospective 5-year postoperative study of cataract extraction and lens implantation. Trans Am Ophthalmol Soc. 1990;8757- 78
Rich  WJCondon  PIPercival  SP Hydrogel intraocular lens experience with endocapsular implantation. Eye. 1988;2 ((pt 5)) 523- 528
Link to Article
Percival  SP Capsular bag implantation of the hydrogel lens. J Cataract Refract Surg. 1987;13627- 629
Link to Article
Nobel  BAHayward  JMHuber  C Secondary evaluation of hydrogel lens implants. Eye. 1990;4 ((pt 3)) 450- 455
Link to Article
Markoff  JLevin  AJBehar  R Uncomplicated bilateral intraocular lens implants: intracapsular and extracapsular results in the same patients. Trans Ophthalmol Soc U K. 1985;104 ((pt 3)) 206- 209
Arnott  ECondon  R The totally encircling loop lens: follow-up of 1800 cases. Cataract. 1985;213- 18
Woodhams  JMaddox  RHunkeler  J  et al.  A review of 1147 cases of Sheet lens implantations. J Am Intraocular Implant Soc. 1984;10185- 187
Link to Article
Straatsma  BRMeyer  KTBastek  JVLightfoot  DO Posterior chamber intraocular lens implantation by ophthalmology residents: a prospective study of cataract surgery. Ophthalmology. 1983;90327- 335
Link to Article
Schlesselman  BS Case-Control Studies.  New York, NY Oxford University Press1982;
Miettinen  OS Estimation of relative risk from individually matched series. Am J Epidemiol. 1976;103226- 235
Mantel  NHaenszel  W Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst. 1959;22719- 748
SAS Institute Inc, SAS Technical Report P-229, SAS/STAT Software: Changes and Enhancements Through Release 6.07. The PHReg Procedure.  Cary, NC SAS Institute Inc1992;chap 19.
Kleinbaum  DGKupper  LLMuller  KE Applied Regression Analysis and Other Multivariable Methods. 2nd ed. Boston, Mass PWS Kent Publications1988;497- 512
Kelsey  JLThompson  WDEvan  AS Methods in Observational Epidemiology.  New York, NY Oxford University Press1986;
Austin  HHill  HAFlanders  WDGreenberg  RS Limitations in the application of case-control methodology. Epidemiol Rev. 1994;1665- 76
Rothman  KJ Modern Epidemiology.  Boston, Mass Little Brown & Co1986;
Cruz  OAWallace  GWGay  CAMatoba  AYKoch  DD Visual results and complications of phacoemulsification with intraocular lens implantation performed by ophthalmology residents. Ophthalmology. 1992;99448- 452
Link to Article
Tarbet  KJMamalis  NTheurer  JJones  BDOlson  RJ Complications and results of phacoemulsification performed by residents. J Cataract Refract Surg. 1995;21661- 665
Link to Article
Stark  WJWorthen  DMHolladay  TJ  et al.  The FDA report on intraocular lenses. Ophthalmology. 1983;90311- 317
Link to Article

Figures

Tables

Table Graphic Jump LocationTable 1. Preoperative Patient Characteristics*
Table Graphic Jump LocationTable 2. Risk of Wound Complication Associated With Hematologic Disorder, by Alcohol Use
Table Graphic Jump LocationTable 3. Operative Findings and Postoperative Results

References

Schein  ODSteinberg  EPJavitt  JC  et al.  Variation in cataract surgery practice and clinical outcomes. Ophthalmology. 1994;1011142- 1152
Link to Article
Cataract Management Guideline Panel, Management of functional impairment due to cataract in adults [Appendix K. Literature review: surgical techniques and complications]. Ophthalmology. 1993;100(suppl)212S- 253S
Link to Article
Steinberg  EPTielsch  JMSchein  OD  et al.  The VF-14: an index of function impairment in patients with cataract. Arch Ophthalmol. 1994;112630- 638
Link to Article
Steinberg  EPTielsch  JMSchein  OD  et al.  National study of cataract surgery outcomes: variation in 4-month postoperative outcomes as reflected in multiple outcome measure. Ophthalmology. 1994;1001131- 1141
Link to Article
Schein  ODSteinberg  EPCassard  SC  et al.  Predictors of outcome in patients who underwent cataract surgery. Ophthalmology. 1995;102817- 823
Link to Article
Drolsum  LHaaskjold  E Causes of decreased visual acuity after cataract extraction. J Cataract Refract Surg. 1995;2159- 63
Link to Article
Sheets  JH A step beyond ECCE. CLAO J. 1987;1367- 70
Heslin  KBGuerriero  PN Clinical retrospective study comparing planned extracapsular cataract extraction and phacoemulsification with and without lens implantation. Ann Ophthalmol. 1984;16956- 962
Steinert  RFBrint  SFWhite  SMFine  IH Astigmatism after small incision cataract surgery: a prospective, randomized, multicenter comparison of 4 and 6.5 incision. Ophthalmology. 1991;98417- 424
Link to Article
Kratz  RPDavidson  BMazzocco  TRColvard  DM The Shearing intraocular lens: a report of 1,000 cases. J Am Intraocul Implant Soc. 1981;755- 57
Link to Article
Cunliffe  IAFlanagan  DWGeorge  NDAggarwaal  RJMoore  AT Extracapsular cataract surgery with lens implantation in diabetes with and without proliferative retinopathy. Br J Ophthalmol. 1990;759- 12
Link to Article
Watts  J Retrospective comparison of lens implant surgery and cataract surgery in a provincial unit. Br J Ophthalmol. 1986;70415- 417
Link to Article
Allen  AWZhang  HR Extracapsular cataract extraction: prognosis and complication with and without posterior chamber lens implantations. Ann Ophthalmol. 1987;19329- 333
Azen  SPHurt  ASteel  D  et al.  Effects of the Shearing posterior chamber intraocular lens on the corneal endothelium. Am J Ophthalmol. 1983;95798- 802
Link to Article
Kooner  KSDulaney  DDZimmerman  TJ Intraocular pressure following extracapsular cataract extraction and posterior lens implantation. Ophthalmic Surg. 1988;19471- 474
Liesegang  TJBourne  WMIlstrup  DM Prospective 5-year postoperative study of cataract extraction and lens implantation. Trans Am Ophthalmol Soc. 1990;8757- 78
Rich  WJCondon  PIPercival  SP Hydrogel intraocular lens experience with endocapsular implantation. Eye. 1988;2 ((pt 5)) 523- 528
Link to Article
Percival  SP Capsular bag implantation of the hydrogel lens. J Cataract Refract Surg. 1987;13627- 629
Link to Article
Nobel  BAHayward  JMHuber  C Secondary evaluation of hydrogel lens implants. Eye. 1990;4 ((pt 3)) 450- 455
Link to Article
Markoff  JLevin  AJBehar  R Uncomplicated bilateral intraocular lens implants: intracapsular and extracapsular results in the same patients. Trans Ophthalmol Soc U K. 1985;104 ((pt 3)) 206- 209
Arnott  ECondon  R The totally encircling loop lens: follow-up of 1800 cases. Cataract. 1985;213- 18
Woodhams  JMaddox  RHunkeler  J  et al.  A review of 1147 cases of Sheet lens implantations. J Am Intraocular Implant Soc. 1984;10185- 187
Link to Article
Straatsma  BRMeyer  KTBastek  JVLightfoot  DO Posterior chamber intraocular lens implantation by ophthalmology residents: a prospective study of cataract surgery. Ophthalmology. 1983;90327- 335
Link to Article
Schlesselman  BS Case-Control Studies.  New York, NY Oxford University Press1982;
Miettinen  OS Estimation of relative risk from individually matched series. Am J Epidemiol. 1976;103226- 235
Mantel  NHaenszel  W Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst. 1959;22719- 748
SAS Institute Inc, SAS Technical Report P-229, SAS/STAT Software: Changes and Enhancements Through Release 6.07. The PHReg Procedure.  Cary, NC SAS Institute Inc1992;chap 19.
Kleinbaum  DGKupper  LLMuller  KE Applied Regression Analysis and Other Multivariable Methods. 2nd ed. Boston, Mass PWS Kent Publications1988;497- 512
Kelsey  JLThompson  WDEvan  AS Methods in Observational Epidemiology.  New York, NY Oxford University Press1986;
Austin  HHill  HAFlanders  WDGreenberg  RS Limitations in the application of case-control methodology. Epidemiol Rev. 1994;1665- 76
Rothman  KJ Modern Epidemiology.  Boston, Mass Little Brown & Co1986;
Cruz  OAWallace  GWGay  CAMatoba  AYKoch  DD Visual results and complications of phacoemulsification with intraocular lens implantation performed by ophthalmology residents. Ophthalmology. 1992;99448- 452
Link to Article
Tarbet  KJMamalis  NTheurer  JJones  BDOlson  RJ Complications and results of phacoemulsification performed by residents. J Cataract Refract Surg. 1995;21661- 665
Link to Article
Stark  WJWorthen  DMHolladay  TJ  et al.  The FDA report on intraocular lenses. Ophthalmology. 1983;90311- 317
Link to Article

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