Effectiveness of early lens extraction for the treatment of primary angle-closure glaucoma (eagle): a randomised controlled trial
Methods Study design and participants
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- Randomisation and masking
| Methods
Study design and participants We did this multicentre, comparative eff ectiveness, randomised, controlled trial in 30 hospital eye services in fi ve countries: Australia (one hospital), mainland China (one), Hong Kong (two), Malaysia (two), Singapore (two), and the UK (22). We recruited patients who were phakic, aged 50 years or older (to limit the eff ect of loss of accommodation associated with clear-lens extraction), and had newly diagnosed primary angle closure with intraocular pressure 30 mm Hg or greater or primary angle-closure glaucoma. Primary angle closure was defi ned as iridotrabecular contact, either appositional or synechial, of at least 180° on gonioscopy, and primary angle-closure glaucoma as reproducible glaucomatous visual fi eld defects, glaucomatous optic neuropathy, or both, and intraocular pressure greater than 21 mm Hg on at least one occasion. Patients with symptomatic cataract, advanced glaucoma (mean deviation worse than –15 dB or cup-to-disc ratio ≥0·9), or previous acute angle-closure attack or who had undergone previous laser or ocular surgery were excluded. An ophthalmologist identifi ed eligible patients and those informed about the study were noted in a log book. People willing to participate completed clinical measurements and study questionnaires at baseline. The study adhered to the tenets of the Declaration of Helsinki and was approved by local institutional review boards. Study participants provided written informed consent. An independent data monitoring committee and an independent trial steering committee provided oversight. Randomisation and masking The randomisation schedule was created with a web-based application at the Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK. The randomisation algorithm used sex, centre, ethnic origin (Chinese or non-Chinese), diagnosis, and one or both eyes suitable for treatment as minimisation covariates. 12 Outcomes assessors were masked when possible, as described later. Patients were assigned in equal proportions to treatment with clear-lens extraction or laser peripheral iridotomy and topical medical treatment (standard care). Enrolment and randomisation was done by the local ophthalmologists. Procedures Topical medications started at the time of diagnosis were continued and the interventions were performed within 60 days of randomisation. If both of a patient’s eyes were suitable for treatment, they were treated in the same way but data for the eye with more severe disease was used in the analysis of eye-level outcomes. If only one eye was suitable for treatment, the other was managed according to the clinical judgment of the ophthalmologist. tải về 315.39 Kb. Chia sẻ với bạn bè của bạn:
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