Purpose
To describe clinical findings associated with an outbreak of toxic anterior segment syndrome (TASS) after implantation of 1-piece intraocular lenses (IOLs; HOYA iSert ® 251 and 255; HOYA Co Ltd, Tokyo, Japan) contaminated with aluminum.
Design
Multicenter observational retrospective case series.
Methods
Cases developing TASS after IOL implantation from November 2011 to February 2013 were reported to the HOYA IOL-Related Endophthalmitis Investigation Committee. Infectious endophthalmitis was excluded. Data were collected on patient backgrounds, the time from IOL implantation to development of the first symptoms, clinical findings, treatment, and best-corrected visual acuity (BCVA) scores before and after treatment. BCVA data were converted into logMAR figures to allow for statistical analysis.
Results
We identified 251 cases of late-onset TASS in patients of mean age 72.85 years treated in 183 hospitals. Common clinical features included the presence of anterior chamber cells (99.2%), conjunctival injection (41.4%), fibrinous inflammation (26.7%), and hypopyon (22.7%). Mean BCVA at the onset of ocular inflammation was 0.253 ± 0.424. The mean time from IOL implantation to development of the first symptoms was 38.44 ± 32.29 days. Of all eyes, 142 were treated with steroids and antibiotics, and 109 underwent surgery, including washing of the anterior chamber, removal of the IOL, and vitrectomy. Mean BCVA after treatment was 0.036 ± 0.242, significantly better than at the onset of ocular inflammation ( P < .05).
Conclusion
This is the first report of an outbreak of late-onset TASS after implantation of a particular type of IOL.
Toxic anterior segment syndrome (TASS) is a noninfectious postoperative inflammatory reaction of the anterior chamber of the eye that develops after cataract surgery. Although the precise mechanism of TASS remains unknown, contamination of surgical equipment or supplies is suspected to be the principal cause. Outbreaks have been reported after the use of particular equipment or supplies. Jehan and associates reported 10 cases of delayed-onset acute intraocular lens (IOL) inflammation that developed after the implantation of hydrophilic acrylic IOLs (MemoryLens; CIBA Vision, Duluth, Georgia, USA). Most cases of TASS responded to topical steroids or topical nonsteroidal anti-inflammatory agents.
Cases of inflammatory reactions in the anterior chamber after implantation of 1-piece acrylic intraocular lenses (IOLs; HOYA iSert 251 and 255; HOYA, Tokyo, Japan), which were 100% hydrophobic acrylic IOLs, were reported to HOYA, Japan, beginning in October 2012. A similar case was reported in the United Kingdom. HOYA stopped selling the IOLs in February 2013. To explore the cause of ocular inflammation, the Japanese Ophthalmological Society established a HOYA IOL-related Endophthalmitis Investigation Commission (hereinafter the “Commission”) that investigated the etiology of ocular inflammation and asked the company to check for contamination of the IOLs or IOL injectors with materials such as endotoxin or ethylene oxide. HOYA reported that the surfaces of unused IOLs were contaminated with aluminum ( Supplemental Figure , available at AJO.com ). Furthermore, the instrument used to wash IOLs in the factory was found to be damaged. The polytetrafluoroethylene coat that covered the aluminum surfaces of the instrument was not intact, and the aluminum was exposed. HOYA had changed the aluminum coating from alumite to polytetrafluoroethylene in November 2011, and thus some IOLs produced after November 2011 could have been contaminated with aluminum. The incidence of ocular inflammation increased after the fixture was modified. The Commission considered that the ocular inflammation could have been caused by contamination with aluminum. Furthermore, the Commission analyzed the characteristics of noninfectious ocular inflammation developing after implantation of HOYA IOLs produced after November 2011.
In this study, we discuss noninfectious ocular inflammation developing after implantation of HOYA IOLs from November 1, 2011 to February 28, 2013.
Methods
A multicenter observational retrospective study was conducted by the HOYA IOL-Related Endophthalmitis Investigation Commission. This study was performed in accordance with the tenets of the Declaration of Helsinki. The Commission received reports on 388 patients who developed ocular inflammation after implantation of an IOL from November 2011 to February 2013. The Commission (not HOYA) sent questionnaires directly to hospitals, and collected data on 332 patients. In addition, the type and serial numbers of IOLs implanted in patients were recorded, and patients without implantation of HOYA iSert 251 and 255 IOLs produced after November 2011 were excluded. The HOYA iSert 251 and 255 IOLs are 100% hydrophobic acrylic IOLs that are fully preloaded. The questionnaire explored patient background, the surgical protocols used, the IOL serial numbers, complications of cataract surgery, days to development of inflammation after IOL implantation, clinical signs determined via slit-lamp microscopy, funduscopy, best-corrected visual acuity (BCVA) before and after the onset of inflammation and at the final follow-up visit, intraocular pressure (IOP) at the onset of inflammation, treatment, and total follow-up duration. BCVA data were converted into logarithm of the minimal angle of resolution (logMAR) units to allow for statistical analysis.
The Commission recorded the IOL serial numbers and dates of manufacture and listed the serial numbers of IOLs manufactured using the instrument in which aluminum was exposed. The Commission next checked the serial numbers of such IOLs in each hospital. The Commission excluded infectious endophthalmitis cases with massive inflammation developing within 1 week of surgery and cases for which microorganisms were detected in ocular fluids. Statistical analysis of BCVA data was performed using a paired 2-tailed t test. A P value < .05 was taken to indicate statistical significance. Treatment was compared using the χ 2 test.
Results
A total of 183 clinical centers answered questionnaires, and a total of 270 patients were registered. Based on the clinical course and microbiological examination, 19 cases of infectious endophthalmitis were excluded. A total of 251 patients were diagnosed with noninfectious endophthalmitis. We examined the serial numbers of IOLs (HOYA iSert 251 and 255) implanted at 183 clinical centers from November 2011 to February 2013 and found that 34 239 IOLs (HOYA iSert 251 and 255) had been implanted. Thus, the incidence rates of infectious and noninfectious endophthalmitis were 0.055% and 0.733%, respectively.
A total of 251 cases of noninfectious endophthalmitis were analyzed. Patient characteristics are shown in Table 1 . There were 89 male patients (89 affected eyes) and 162 female patients (162 affected eyes). Right and left eyes were affected in 137 and 113 cases, respectively; the affected eye in 1 patient was not noted. Mean patient age was 72.85 ± 9.48 years (± standard deviation, SD) at the time of ocular inflammation. The most common comorbid conditions were hypertension (73 of 251, 29.1%) and diabetes (41 of 251, 16.3%), and 8 patients (8 of 251, 3.2%) had uveitis prior to cataract surgery. Phacoemulsification was used in all cases, and the incisions were clear corneal incisions in 47 cases and scleral incisions in 201 cases. HOYA iSert 251 and 255 IOLs were implanted in 246 and 5 patients, respectively. Seven patients developed intraoperative complications associated with cataract surgery, including damage to zonular fibers (3 patients), non-self-sealing incision (1 patient), posterior capsule rupture (1 patient), and intraoperative floppy iris syndrome (1 patient). Antibiotics delivered in eye drops via subconjunctival injection, or via intracameral injection, were given to 220 patients immediately after surgery, and 127 patients received subconjunctival injections of steroids. Topical antibiotics, steroids, and nonsteroidal anti-inflammatory drugs were given to 248, 223, and 244 patients, respectively, after surgery. The mean BCVA prior to the onset of ocular inflammation was 0.019 ± 0.152.
| Characteristics | Value |
|---|---|
| Age (y), mean ± SD | 72.85 ± 9.48 |
| Sex, n (%) | |
| Female | 89 (35.5) |
| Male | 162 (64.5) |
| Comorbid condition, n (%) | |
| Hypertension | 73 (29.1) |
| Diabetes | 41 (16.3) |
| Dyslipidemia | 15 (6) |
| Cerebral infarction | 11 (4.4) |
| Angina pectoris | 7 (2.8) |
| Asthma | 7 (2.8) |
| Renal insufficiency | 6 (2.4) |
| Rheumatism | 5 (2) |
| Arrhythmia | 5 (2) |
The number of days after cataract surgery on which ocular inflammation developed is shown in the Figure . The mean onset time was 38.44 ± 32.29 (range 0-161) days. At the time of onset, 117 patients were not using topical steroids. The clinical features at onset are listed in Table 2 . The most common presenting signs were the appearance of inflammatory cells in the anterior chamber (249/251 eyes, 99.2%) and conjunctival injection (104/251 eyes, 41.4%). Although vitreous opacity was found in 54 patients, the fundus in those patients could be observed owing to slight vitreous opacities, and there were no fundus abnormalities. Moreover, no patients suffered from chronic ocular hypertension or a marked endothelial defect. The mean BCVA at the onset of ocular inflammation was 0.253 ± 0.424 (logMAR), and was significantly greater than the BCVA prior to the development of inflammation ( P < .001). The mean IOP was 14.03 ± 6.08 (range 5-58) mm Hg.
| Sign | N (%) |
|---|---|
| Inflammatory cells in anterior chamber | 249 (99.2) |
| Conjunctival injection | 104 (41.4) |
| Keratic precipitates | 70 (27.9) |
| Fibrinous inflammations | 67 (26.7) |
| Hypopyon | 57 (22.7) |
| Vitreous opacity | 54 (21.5) |
| Corneal edema | 48 (19.1) |
The treatments for ocular inflammation are listed in Table 3 . Topical steroids, topical nonsteroidal anti-inflammatory agents, and topical antibiotics were used in 223, 179, and 240 cases, respectively. Of all patients, 142 (56.6%) were treated with medication alone. Surgeries, including irrigation of the anterior chamber, removal of the IOL, and vitrectomy, were performed in 109 patients (43.4%). We divided patients into 2 groups: Group 1, patients with only inflammatory cells in the anterior chamber; and Group 2, patients with hypopyon, fibrinous inflammation, or vitreous opacity along with cells in the anterior chamber. Group 2 received significantly less topical steroid and underwent more surgeries compared with Group 1, including anterior chamber irrigation or vitrectomy. The mean follow-up duration for all patients was 198.16 ± 114.51 days. The mean BCVA at the final visit was 0.036 ± 0.242, and was significantly better than at the onset of inflammation ( P < .001). The BCVA prior to the development of inflammation did not differ significantly from that at the final visit ( P = .75).
| Treatment, N (%) | Fibrinous Inflammations, Hypopyon, or/and Vitreous Opacity | Total | P Value c | |
|---|---|---|---|---|
| Positive a (124 Patients) | Negative b (127 Patients) | 251 Patients | ||
| Medical treatment | ||||
| Topical steroid | 102 (82.3) | 118 (92.9) | 220 (87.6) | .018 |
| Topical nonsteroidal anti-inflammatory agents | 83 (66.9) | 98 (77.2) | 181 (72.1) | .071 |
| Topical antibiotics | 120 (96.8) | 120 (94.5) | 240 (95.6) | .376 |
| Surgical treatment | 69 (55.6) | 40 (31.5) | 109 (43.4) | <.001 |
| Anterior chamber irrigation | 51 (41.1) | 25 (19.7) | 76 (30.3) | <.001 |
| Vitrectomy | 49 (39.5) | 28 (22.0) | 77 (30.7) | .003 |
| Removal of IOL | 22 (17.7) | 16 (12.6) | 38 (15.1) | .256 |
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