Ten-year follow-up of fellow eyes of patients enrolled in Collaborative Ocular Melanoma Study randomized trials: Coms report no. 22☆
Received 23 January 2003; accepted 18 August 2003.
Abstract
Purpose
To report findings observed in fellow eyes during prospective follow-up of patients with unilateral choroidal melanoma after treatment with standard enucleation or 1 of 2 radiotherapy methods, either iodine 125 (I125) brachytherapy or pre-enucleation external radiation, in order to document long-term outcomes and to identify any adverse effect of radiotherapy on the contralateral eye.
Design
Two multicenter randomized trials conducted by the Collaborative Ocular Melanoma Study (COMS) Group.
Participants
Eligible patients assigned randomly to standard enucleation or to the radiotherapy protocol adopted for tumors of the specified size and location and treated as assigned: 994 patients of 1003 enrolled in the COMS trial of pre-enucleation radiation and 1296 patients of 1317 enrolled in the COMS trial of I125 brachytherapy.
Outcomes
Changes in best-corrected visual acuity (VA), intraocular pressure, and other findings in fellow eyes from baseline to examinations conducted at 6 and 12 months after enrollment and annually thereafter.
Results
Five years after enrollment, 1307 of 2290 fellow eyes were examined; 358 fellow eyes were examined 10 years after enrollment. Mean change in VA of fellow eyes from baseline to each examination was one letter (0.2 lines) or less. Cumulative 5-year incidence rates of cataract surgery and visually significant cataract in initially phakic eyes with good VA and no lenticular opacity were 8% in both trials; 10-year rates were 18% in the trial of pre-enucleation and 15% in the trial of I125 brachytherapy. Intraocular pressures changed by less than 1 mmHg from baseline to each examination. Apart from lower rates of incident cataracts among fellow eyes of patients treated with pre-enucleation radiation, findings within each trial were similar in the 2 treatment arms.
Conclusions
Almost all surviving patients retained good VA in fellow eyes throughout 5 years of follow-up after treatment for choroidal melanoma. These findings persisted through 10 years of follow-up among patients eligible for examinations beyond 5 years. There was no evidence that fellow eyes of patients whose affected eye was treated with pre-enucleation radiation or with I125 brachytherapy were at greater risk of loss of VA or new ophthalmic diagnoses than eyes of patients treated with enucleation alone.
Correspondence and reprint requests to Barbara S. Hawkins, PhD, COMS Coordinating Center, Wilmer Clinical Trials and Biometry, 550 North Broadway, 9th Floor, Baltimore, MD 21205-2010, USA.
No member of the writing team for this report has any commercial interest in any of the products used in the conduct of the Collaborative Ocular Melanoma Study.
The COMS has received support from the National Eye Institute and the National Cancer Institute through cooperative agreements EY06253, EY06257, EY06258, EY06259, EY06260, EY06264, EY06265, EY06266, EY06268, EY06269, EY06270, EY06274, EY06275, EY06276, EY06279, EY06280, EY06282, EY06283, EY06284, EY06287, EY06288, EY06289, EY06291, EY06839, EY06843, EY06844, EY06848, EY06858, and EY06899 with the National Institutes of Health, Bethesda, Maryland.
* Prepared for the COMS Group by Sumit K. Nanda, MD (Oklahoma Retina Institute, Oklahoma City, Oklahoma), Sandra M. Reynolds, MA (The Wilmer Ophthalmological Institute, Baltimore, Maryland), Peter K. Kaiser, MD (Cole Eye Institute, Cleveland, Ohio), Hector L. Sulit, MD (University of California, Los Angeles and Long Beach, California), Suresh R. Chandra, MD (University of Wisconsin, Madison, Wisconsin), Reagan H. Bradford, Jr, MD (McGee Eye Institute, Oklahoma City, Oklahoma), Stuart L. Fine, MD (Scheie Ophthalmological Institute, Philadelphia, Pennsylvania), Barbara S. Hawkins, PhD (The Wilmer Ophthalmological Institute, Baltimore, Maryland). Lists of members of the COMS Group can be found in Refs. .
ABSTRACT