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Purpose To review data on malpractice claims related to refractive surgery to identify common allegations and injuries and financial outcomes. Methods The WestlawNext database was reviewed for all malpractice lawsuits/settlements related to refractive eye surgery. Data evaluated included patient demographics, type of operation performed, plaintiff allegation, nature of injury, and litigation outcomes. Results A total of 167 cases met the inclusion criteria, of which 108 cases (64.7%) were found to be favorable and 59 cases (35.3%) unfavorable to the defendant. A total of 141 cases were tried by a jury with 108 cases (76.4%) favorable and 33 cases (23.6%) unfavorable to the defendant. Laser in situ keratomileusis was performed in 127 cases (76%). The most common allegations were negligence in treatment or surgery in 127 cases (76%) and lack of informed consent in 83 cases (49.7%). For all cases, the need for future surgery (P = 0.0001) and surgery resulting in keratoconus (P = 0.05) were more likely to favor the plaintiff. In jury verdict decisions, cases in which failure to diagnose a preoperative condition was alleged favored the defendant (P = 0.03), whereas machine malfunction (P = 0.05) favored the plaintiff. After adjustment for inflation, the overall mean award was $1,287,872. Jury verdicts and settlements led to mean awards of $1,604,801 and $826,883, respectively. Conclusions Malpractice litigation in refractive surgery tends to favor the defendant. However, large awards and settlements were given in cases that were favorable to the plaintiff. The need for future surgery and surgery leading to keratoconus increased the chance of an unfavorable outcome.

BACKGROUND/AIMS To compare the effectiveness and side-effect profile of two doses of interferon alpha2b (IFNalpha2b) eye-drops (1 million international units (IU)/ml versus 3 million IU/ml) in the treatment of ocular surface squamous neoplasia (OSSN). METHODS Retrospective case series. RESULTS Thirty-five eyes were identified over an 11-year period (1996-2007). Twenty-one eyes (19 patients) with conjunctival intraepithelial neoplasia (CIN) were treated with 1 million IU/ml of topical IFN-alpha2b; 12 eyes (nine patients) with CIN were treated with 3 million IU/ml. Two patients with squamous cell carcinoma (SCC) were treated with topical interferon, one with 1 million IU/ml and one with 3 million IU/ml. Baseline demographic information was not statistically different between the two groups. In patients with CIN, topical therapy eliminated disease in 81% of eyes in the 1 million IU/ml group versus 92%, in the 3 million IU/ml group, p=0.41. The median time to OSSN resolution was 2.8 months in the 1 million IU/ml group and 1.9 months in the 3 million IU/ml group, p=0.55. Neither eye with SCC responded to interferon therapy. Topical therapy was well tolerated. After a median follow-up of 24 months, three recurrences were seen in eyes successfully treated with topical therapy. CONCLUSION In our study, there were no significant differences between the 1 million IU/ml group and the 3 million IU/ml group for the treatment of CIN.

Purpose To determine the incidence of and risk factors for fungal keratitis and endophthalmitis in patients with a Boston keratoprosthesis (KPro) and to determine whether surveillance cultures were helpful in predicting fungal infection. Methods A retrospective chart review was performed of 182 patients (202 eyes) who received a type 1 (through cornea) or type 2 (through cornea and lid) KPro between March 1, 1990, and December 31, 2004, and who were followed for at least 1 month (range, 1 month to 13 years; mean, 2.84 years). There were 148 eyes with type 1 and 54 eyes with type 2. Beginning in late 1999, many eyes were given a prophylactic topical regimen containing vancomycin, and many eyes with type 1 KPro were given therapeutic contact lenses. Cases of fungal keratitis or endophthalmitis were analyzed. To determine the fungal colonization rate, 70 surveillance cultures of the ocular or lid surface around the KPro optic were obtained of 36 uninfected KPro eyes (35 patients) at random time-points over 1 year (August 2002 to July 2003). Results There were 4 definite and 1 probable fungal infections in 6893 patient-months of follow-up, or 0.009 fungal infections per patient-year. These included 3 cases of definite or probable Candida endophthalmitis (C. parapsilosis, C. glabrata, and C. albicans) and 2 cases of mold keratitis (Alternaria, Fusarium). The rate was higher in eyes receiving a vancomycin-containing topical prophylactic regimen than those with on a non-vancomycin regimen (5 cases/2774 person-months vs. 0 cases/4119 person-months; P = 0.011). In eyes with type 1 KPro, the rate was higher with therapeutic contact lens wear than without (4/1682 vs. 0/3115 person-months; P = 0.015). Surveillance cultures did not predict fungal infection, and none of the 6 surveillance eyes colonized with fungi (all Candida) developed a fungal infection. The prevalence of fungal colonization in KPro eyes had not changed since our 1996 surveillance study (11% vs. 10%, P > 0.05). Conclusion Fungal infections in KPro eyes have appeared since we introduced broad-spectrum antibiotic prophylaxis and therapeutic contact lenses 5 years ago, but the infection rate remains very low in our mostly New England-based patient population. Cleaning or replacing the contact lens on a regular basis and prescribing a short course of topical amphotericin at the first visible signs of fungal colonization may prevent these infections.

To evaluate the biologic effect of subconjunctival recombinant interferon α2b (IFNα2b) for the treatment of ocular surface squamous neoplasia (OSSN).Retrospective study.Patients with primary or recurrent OSSN treated with subconjunctival injections of recombinant IFNα2b were studied retrospectively.Patients were given perilesional subconjunctival injections of 3 million international units in 0.5 ml of IFNα2b (Intron; Schering-Plough, Kenilworth, NJ) until tumor resolution.Patients were followed up clinically and photographically for evidence of tumor resolution and were monitored for evidence of tumor recurrence.The authors present a series of 15 eyes (14 patients) that were treated with perilesional, subconjunctival, recombinant IFNα2b. Clinical resolution of the tumor occurred in 13 of 15 eyes. The median time to resolution was 1.4 months (range, 0.6-5.7). In the time of follow-up after lesion resolution (median, 55 months), only 1 of the 15 eyes in the study exhibited disease recurrence, and this occurred 4 months after clinical resolution.Perilesional subconjunctival recombinant IFNα2b may be a viable medical alternative for the treatment of OSSN. Future studies will be needed to evaluate the ideal treatment regimen of IFNα2b.

Purpose To document the incidence and treatment of patients with severe ocular and ocular adnexal injuries during Operation Iraqi Freedom. Design Retrospective hospital-based observational analysis of injuries. Participants All coalition forces, enemy prisoners of war, and civilians with severe ocular and ocular adnexal injuries. Methods The authors retrospectively examined severe ocular and ocular adnexal injuries that were treated by United States Army ophthalmologists during the war in Iraq from March 2003 through December 2005. Main Outcome Measures Incidence, causes, and treatment of severe ocular and ocular adnexal injuries. Results During the time data were gathered, 797 severe eye injuries were treated. The most common cause of the eye injuries was explosions with fragmentation injury. Among those injured, there were 438 open globe injuries, of which 49 were bilateral. A total of 116 eyes were removed (enucleation, evisceration, or exenteration), of which 6 patients required bilateral enucleation. Injuries to other body systems were common. Conclusions Severe eye injuries represent a significant form of trauma encountered in Operation Iraqi Freedom. These injuries were most commonly caused by explosion trauma.

Purpose To review the incidence, culture results, clinical course, management, and visual outcomes of infectious keratitis after photorefractive keratectomy (PRK) at 6 Army and Navy refractive surgery centers. Design Retrospective study. Participants Twelve thousand six hundred sixty-eight Navy and Army sailors and service members. Methods Army and Navy refractive surgery data banks were searched for cases of infectious keratitis. A retrospective chart review and query of the surgeons involved in the care of those patients thus identified provided data regarding preoperative preparation, perioperative medications, treatment, culture results, clinical course, and final visual acuity. Results Between January 1995 and May 2004, we performed a total of 25337 PRK procedures at the 6 institutions. Culture proven or clinically suspected infectious keratitis developed in 5 eyes of 5 patients. All patients received topical antibiotics perioperatively. All cases presented 2 to 7 days postoperatively. Cultures from 4 cases grew Staphylococcus , including 2 methicillin-resistant S. aureus (MRSA). One case of presumed infectious keratitis was culture negative. There were no reported cases of mycobacterial or fungal keratitis. In addition, we identified 26 eyes with corneal infiltrates in the first postoperative week that were felt to be sterile, and which resolved upon removal of the bandage contact lens and increasing antibiotic coverage. Conclusions Infectious keratitis is a rare but potentially vision-threatening complication after PRK. It is often caused by gram-positive organisms, including MRSA. Early diagnosis, appropriate laboratory testing, and aggressive antimicrobial therapy can result in good outcomes.