Refractive Surgery: Malpractice Litigation Outcomes.

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.

Subconjunctival/perilesional recombinant interferon α2b for ocular surface squamous neoplasia: a 10-year review.

PURPOSE: To evaluate the biologic effect of subconjunctival recombinant interferon α2b (IFNα2b) for the treatment of ocular surface squamous neoplasia (OSSN). DESIGN: Retrospective study. PARTICIPANTS: Patients with primary or recurrent OSSN treated with subconjunctival injections of recombinant IFNα2b were studied retrospectively. INTERVENTION: 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. MAIN OUTCOME MEASURES: Patients were followed up clinically and photographically for evidence of tumor resolution and were monitored for evidence of tumor recurrence. RESULTS: 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. CONCLUSIONS: 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.

Current trends in advanced surface ablation.

PURPOSE OF REVIEW: Since their introduction in the mid-1990s, surface ablation techniques have continued to evolve, enabling surgeons to give patients better quality of vision with less postoperative pain. The purpose of this chapter is to discuss that evolution, the common techniques used today, and how to address potential complications. RECENT FINDINGS: Advanced surface ablation techniques offer advantages over laser in situ keratomileusis, including expanded potential patient profiles, reduced haze and pain postoperatively, and increased quality of vision. Haze reduction via preserved epithelial flaps, smoother stromal beds, and introduction of mitomycin-C intraoperatively have all improved safety outcomes of advanced surface ablation. SUMMARY: Experience has shown us that virtually all patients who are candidates for laser in situ keratomileusis can be candidates for surface ablation, but patients with specific ocular conditions, such as epithelial basement membrane dystrophy, superficial corneal scars, and previous radial keratotomy will have the best outcomes with surface ablation. Surface ablation and laser in situ keratomileusis are comparable in terms of safety and quality of vision. Wavefront-guided photorefractive keratectomy offers better acuity and less induction of higher order aberrations than wavefront-guided laser in situ keratomileusis.

Severe eye injuries in the war in Iraq, 2003-2005.

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.

Fungal colonization and infection in Boston keratoprosthesis.

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.

Infectious keratitis after photorefractive keratectomy in the United States army and navy.

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.