Interim clinical outcomes in the collaborative initial glaucoma treatment study comparing initial treatment randomized to medications or surgery☆
Section snippets
Patients and methods
Enrollment took place at 14 clinical centers from October 1993 through April 1997. Each clinical center and the study operations centers (administrative, coordinating, and quality of life) received institutional review board approval for the study. Eligible patients must have had (1) newly diagnosed open-angle glaucoma (primary, pseudoexfoliative, and pigmentary forms) in one or both eyes; (2) one of three combinations of qualifying IOP, VF changes, and optic disc findings; (3) a best-corrected
Results
Fourteen clinical centers screened 1190 subjects for enrollment from October 1993 through April 1997. Of those screened, 728 (61%) were found to be eligible to participate. Six hundred seven (83%) of these eligible patients agreed to participate, and the remaining 121 (17%) decided against participation. The latter patients were older than those who agreed to participate. Reasons for refusal included concerns regarding surgery (n = 43, 36%), study burden (n = 28, 23%), lack of interest (n = 21,
Discussion
When the CIGTS was organized, studies in England and Scotland16, 17 suggested that early trabeculectomy was preferable to treatment with medication to prevent progression of VF loss. The authors attributed differences in VF progression to the extent of IOP control, which was best in the surgery group. It seems that the patients in the British studies may have had more advanced glaucoma than did our patients, which could account for greater visual field progression in a shorter period of time
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The CIGTS is funded by the National Institutes of Health, National Eye Institute, Bethesda, Maryland, grant numbers EY09100, EY09140, EY09141, EY09142, EY09143, EY09144, EY09145, EY09148, EY09149, EY09150, and EY09639.