The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma III: local complications and observations following enucleation COMS report no. 11.

PURPOSE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.

RCT Entities:   Population Interventions Outcomes