Ophthalmology · 2017
Outbreak of Subacute-Onset Toxic Anterior Segment Syndrome Associated with Single-Piece Acrylic Intraocular Lenses.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Oshika Tetsuro, Eguchi Shuichiro, Goto Hiroshi, Ohashi Yuichi
Аннотация
PURPOSE: To report the results of a clinical investigation after an outbreak of subacute-onset toxic anterior segment syndrome (TASS) after implantation of single-piece acrylic intraocular lenses (IOLs), which then were recalled voluntarily from the market.
DESIGN: Retrospective, multicenter, observational case series.
PARTICIPANTS: Cases reported to the manufacturer from January 2015 through March 2016 of unusual ocular inflammation after cataract surgery using AcrySof ReSTOR, ReSTOR toric, or AcrySof IQ toric SN6AT6-9 IOLs (Alcon Laboratories, Inc., Fort Worth, TX).
METHODS: The independent investigation committee, not Alcon, directly requested the surgeons for data on 304 eyes from 184 facilities.
RESULTS: Consent for data collection was obtained for 201 eyes from 130 facilities. By excluding cases with infectious endophthalmitis and inconclusive cases, the investigation committee identified 147 cases of subacute-onset TASS. AcrySof ReSTOR or ReSTOR toric IOLs and AcrySof IQ toric SN6AT6-9 IOLs were implanted in 94 eyes (63.9%) and 53 eyes (36.1%), respectively. The mean onset time was 13.1±16.4 days after surgery (range, 1-88 days), with 84 eyes (57.1%) demonstrating symptoms within 7 days after surgery. Typical clinical symptoms were mild to moderate exacerbation of inflammation in the anterior chamber after an uneventful clinical course for a few days after surgery. One hundred four eyes (70.7%) were treated with medication alone, and 43 eyes (29.3%) underwent surgery, including irrigation of the anterior chamber, vitrectomy, and removal of the IOL. The mean best-corrected visual acuity (BCVA) at the final visit (-0.012±0.175 logarithm of the minimum angle of resolution [logMAR]) was significantly better than the BCVA at the onset of TASS (0.158±0.351 logMAR) and did not differ from that before inflammation developed (-0.004±0.162 logMAR). Overall treatment outcomes were favorable.
CONCLUSIONS: A large-scale outbreak of subacute-onset TASS developed after implantation of a specific model of IOL.
DESIGN: Retrospective, multicenter, observational case series.
PARTICIPANTS: Cases reported to the manufacturer from January 2015 through March 2016 of unusual ocular inflammation after cataract surgery using AcrySof ReSTOR, ReSTOR toric, or AcrySof IQ toric SN6AT6-9 IOLs (Alcon Laboratories, Inc., Fort Worth, TX).
METHODS: The independent investigation committee, not Alcon, directly requested the surgeons for data on 304 eyes from 184 facilities.
RESULTS: Consent for data collection was obtained for 201 eyes from 130 facilities. By excluding cases with infectious endophthalmitis and inconclusive cases, the investigation committee identified 147 cases of subacute-onset TASS. AcrySof ReSTOR or ReSTOR toric IOLs and AcrySof IQ toric SN6AT6-9 IOLs were implanted in 94 eyes (63.9%) and 53 eyes (36.1%), respectively. The mean onset time was 13.1±16.4 days after surgery (range, 1-88 days), with 84 eyes (57.1%) demonstrating symptoms within 7 days after surgery. Typical clinical symptoms were mild to moderate exacerbation of inflammation in the anterior chamber after an uneventful clinical course for a few days after surgery. One hundred four eyes (70.7%) were treated with medication alone, and 43 eyes (29.3%) underwent surgery, including irrigation of the anterior chamber, vitrectomy, and removal of the IOL. The mean best-corrected visual acuity (BCVA) at the final visit (-0.012±0.175 logarithm of the minimum angle of resolution [logMAR]) was significantly better than the BCVA at the onset of TASS (0.158±0.351 logMAR) and did not differ from that before inflammation developed (-0.004±0.162 logMAR). Overall treatment outcomes were favorable.
CONCLUSIONS: A large-scale outbreak of subacute-onset TASS developed after implantation of a specific model of IOL.
Предметные рубрики MeSH
Acrylic ResinsAcute DiseaseAdultAgedAged, 80 and overAnterior Eye SegmentAnti-Bacterial AgentsDisease OutbreaksEndophthalmitisEquipment ContaminationFemaleHumansLens Implantation, IntraocularLenses, IntraocularMaleMedical Device RecallsMiddle AgedOphthalmologic Surgical ProceduresPhacoemulsificationProsthesis DesignReoperationRetrospective StudiesTime FactorsVisual Acuity