Am J Ophthalmol. 1998 Sep;126(3):362-72. doi: 10.1016/s0002-9394(98)00091-9.
To summarize local complications and observations following enucleation of eyes with large choroidal melanoma that were reported prospectively at scheduled examinations of patients enrolled in the Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation.
Of 1,003 patients with large choroidal melanoma who were assigned randomly at time of enrollment to enucleation alone or to pre-enucleation radiation, 994 were treated as assigned. Complications and observations were reported to the Coordinating Center on standard forms completed at the time of enucleation surgery and during the immediate 24-hour postsurgery period, 1 to 6 weeks following surgery, 6 and 12 months after enucleation, and at examinations scheduled at 12-month intervals thereafter.
The most common perioperative complication was pain that prolonged hospital stay, which was reported for six patients (1%) who had standard enucleation and eight patients (2%) who had pre-enucleation radiation. Patients treated with pre-enucleation radiation had somewhat more complications reported at the examination 1 to 6 weeks after surgery than did patients treated with enucleation alone, 36 (8%) and 21 (4%), respectively (P = .03, chi2 test), but all complications were minor. During follow-up, fewer biopsy-confirmed tumor recurrences in the orbit were observed among patients treated with pre-enucleation radiation than with enucleation alone (0 vs 5, respectively; P = .03, Fisher exact test). Patients treated with pre-enucleation radiation also had a lower incidence of severe ptosis than did patients treated with enucleation alone (P = .007, log rank test). Among 307 patients examined 5 years after enucleation, the most frequent complication reported at the 5-year examination was poor prosthetic motility for 24 patients (16%) treated with enucleation alone and 30 patients (19%) treated with pre-enucleation radiation.
Complications were infrequent during the 5-year period following enucleation surgery. Five-year incidence rates and prevalence at the 5-year examination of most complications were similar in the two treatment arms. There was no indication that pre-enucleation radiation had resulted in more serious complications.
总结在协作性眼黑色素瘤研究（COMS）的眼球摘除术前放疗随机试验中，对患有大脉络膜黑色素瘤的患者进行眼球摘除术后的局部并发症及观察结果，这些结果是在预定检查时前瞻性报告的。
1003例患有大脉络膜黑色素瘤的患者在入组时被随机分配至单纯眼球摘除组或眼球摘除术前放疗组，其中994例按分配方案接受了治疗。并发症及观察结果通过在眼球摘除手术时、术后24小时内、术后1至6周、眼球摘除术后6个月和12个月以及此后每隔12个月安排的检查时填写的标准表格报告给协调中心。
最常见的围手术期并发症是导致住院时间延长的疼痛，单纯眼球摘除的6例患者（1%）和眼球摘除术前放疗的8例患者（2%）报告了该并发症。眼球摘除术前放疗的患者在术后1至6周检查时报告的并发症比单纯眼球摘除的患者略多，分别为36例（8%）和21例（4%）（P = 0.03，卡方检验），但所有并发症均为轻度。在随访期间，眼球摘除术前放疗的患者眼眶内活检证实的肿瘤复发少于单纯眼球摘除的患者（分别为0例和5例；P = 0.03，Fisher精确检验）。眼球摘除术前放疗的患者重度上睑下垂的发生率也低于单纯眼球摘除的患者（P = 0.007，对数秩检验）。在307例眼球摘除术后5年接受检查的患者中，5年检查时报告的最常见并发症是单纯眼球摘除治疗的24例患者（16%）和眼球摘除术前放疗治疗的30例患者（19%）出现义眼活动不良。
眼球摘除术后5年内并发症不常见。两个治疗组大多数并发症的5年发生率及5年检查时的患病率相似。没有迹象表明眼球摘除术前放疗导致了更严重的并发症。
