The Collaborative Ocular Melanoma tudy (COM) randomized trial of pre-enucleation radiation of large choroidal melanoma III: local complication and obervation following enucleation COM report no. 11 Original Reearch Article

To ummarize local complication and obervation following enucleation of eye with large choroidal melanoma that were reported propectively at cheduled examination of patient enrolled in the Collaborative Ocular Melanoma tudy (COM) randomized trial of pre-enucleation radiation. METHOD Of 1,003 patient with large choroidal melanoma who were aigned randomly at time of enrollment to enucleation alone or to pre-enucleation radiation, 994 were treated a aigned. Complication and obervation were reported to the Coordinating Center on tandard form completed at the time of enucleation urgery and during the immediate 24-hour poturgery period, 1 to 6 week following urgery, 6 and 12 month after enucleation, and at examination cheduled at 12-month interval thereafter. REULT The mot common perioperative complication wa pain that prolonged hopital tay, which wa reported for ix patient (1%) who had tandard enucleation and eight patient (2%) who had pre-enucleation radiation. Patient treated with pre-enucleation radiation had omewhat more complication reported at the examination 1 to 6 week after urgery than did patient treated with enucleation alone, 36 (8%) and 21 (4%), repectively (P = .03, χ2 tet), but all complication were minor. During follow-up, fewer biopy-confirmed tumor recurrence in the orbit were oberved among patient treated with pre-enucleation radiation than with enucleation alone (0 v 5, repectively; P = .03, Fiher exact tet). Patient treated with pre-enucleation radiation alo had a lower incidence of evere ptoi than did patient treated with enucleation alone (P = .007, log rank tet). Among 307 patient examined 5 year after enucleation, the mot frequent complication reported at the 5-year examination wa poor prothetic motility for 24 patient (16%) treated with enucleation alone and 30 patient (19%) treated with pre-enucleation radiation. CONCLUION Complication were infrequent during the 5-year period following enucleation urgery. Five-year incidence rate and prevalence at the 5-year examination of mot complication were imilar in the two treatment arm. There wa no indication that pre-enucleation radiation had reulted in more eriou complication.