Effectiveness of early lens extraction for the treatment of primary angle-closure glaucoma (eagle): a randomised controlled trial
Participants assigned to clear-lens extraction underwent
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Participants assigned to clear-lens extraction underwent phacoemulsifi cation with a monofocal intraocular lens implant. Temporary treatment with eye drops was allowed while patients were awaiting surgery. Synechiolysis was allowed according to local practice. Fully qualifi ed ophthalmologists who had completed general training in ophthalmology and specialist training in glaucoma did the surgeries. Laser iridoplasty was allowed after standard care if angle closure persisted. A target intraocular pressure of 15–20 mm Hg was set at baseline dependent on the degree of optic nerve damage. Topical medical therapy could be escalated (ie, by increasing the number of medications) to achieve this target. If maximum medical therapy did not control the intraocular pressure, the ophthalmologist could off er and choose the type of glaucoma surgery. The need for glaucoma surgery was classifi ed as a treatment failure, but participants remained in the trial. Patients assigned to standard care could undergo lens extraction during the study period only when indicated clinically for reduced vision (ie, cataract surgery) or if the treating ophthalmologist judged that lens extraction could help control the intraocular pressure. Assessments We measured health status with the European Quality of Life-5 Dimensions (EQ-5D) questionnaire, which assesses fi ve dimensions of health (mobility, self-care, usual activity, pain or discomfort, and anxiety or depression) at three levels (no problems, some problems, extreme problems). 13,14 Each of the 243 health states that may be described by the instrument can be assigned a single preference-based utility score, which we calculated with the UK general population tariff for time trade-off . 15 The questionnaires were self-reported by patients, who were aware of treatment allocation. Intraocular pressure was taken to be the average of two readings by Goldmann tonometry. Two observers at each site, following a masking protocol, were involved in the measurements. One observer randomly set the starting force and recorded the pressure values obtained by the other observer, who interacted directly with the patient but did not look at the results on the measurement dial. Outcomes were assessed at baseline and 6, 12, 24, and 36 months after randomisation. We captured data on use of UK National Health Service (NHS) resources with the use of case report forms. Results of all eye procedures and outpatient follow-up assessments and use of all medications for UK patients were recorded and patients were asked to complete questionnaires during primary care, community nurse, and optometrist visits. The results were combined with national unit cost data for the fi nancial year 2012–13 to estimate total costs per participant to 36 months. 16–18 Total quality-adjusted life-years (QALYs) were calculated for each participant on the basis of their EQ-5D utility scores at baseline and at 6, 12, 24, and 36 months, and we assumed that change in health state use between time points would be linear. Full details of the economic analysis and modelling to extrapolate cost-eff ectiveness over longer time periods will be published elsewhere. To assess the eff ects of vision problems on vision-targeted functioning and health-related quality of life, we used the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25). 19,20 This questionnaire has 11 subscales and one general health rating question, from which a composite score is generated. Additionally, we used the Glaucoma Utility Index, which provides a descriptive profi le in six dimensions: central and near vision, lighting and glare, mobility, activities of daily living, eye discomfort, and other eff ects of glaucoma and its treatment, each with four levels. 21 Best-corrected visual acuity was tested with the Early Treatment Diabetic Retinopathy Study (ETDRS) charts 22 and extension of angle closure was determined by gonioscopy. To test the visual fi eld, we used a standard automated perimetry test (Humphrey SITA 24-2 test). tải về 315.39 Kb. Chia sẻ với bạn bè của bạn:
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