Effectiveness of early lens extraction for the treatment of primary angle-closure glaucoma (eagle): a randomised controlled trial
Participants did two tests at baseline and one at 6, 12, 24
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- Figure 1 : Trial profi le Articles 1392
- Statistical analysis
Participants did two tests at baseline and one at 6, 12, 24, and 36 months. Individual disease progression was defi ned as a worsening of one or more stages according to the Glaucoma Staging System-2, 23 and was decided by graders unaware of participants’ treatment allocations. Visual fi eld tests were deemed to be unreliable when false-positive errors were greater than 15%. Safety Any expected or unexpected complications during treatment or at any time during follow-up were recorded on case-report forms and submitted to the data monitoring committee, including loss of best-corrected visual acuity of more than ten ETDRS letters. Serious adverse events were 805 patients assessed for eligibility 386 patients ineligible or chose not to participate 419 enrolled 419 randomised 208 assigned to clear-lens extraction 4 patients data not available 204 included in the intention-to-treat analysis 211 assigned to laser peripheral iridotomy 6 patients data not available 205 included in the intention-to-treat analysis Figure 1: Trial profi le Articles 1392 www.thelancet.com Vol 388 October 1, 2016 reported in accordance with the guidance from the National Research Ethics Service, which is a subdivision of the National Patient Safety Agency. Statistical analysis We calculated that with 170 participants in each group, the study would have 90% power at 5% signifi cance level to detect a diff erence in mean EQ-5D score of 0·35 SD, which represents an absolute change in score of 0·05 20 and is likely to be clinically important. We estimated that the SD for intraocular pressure at 36 months would be 5 mm Hg and similar in the two randomised groups. 24–26 We therefore calculated that the study would have 90% power at a 5% level of signifi cance to detect a mean diff erence of 1·75 mm Hg. Additionally, with the assumption that a maximum of 40% of patients would need glaucoma surgery, the power to detect a diff erence of 15% in the need for glaucoma surgery would be 80%. Thus, allowing for 15% loss to follow-up at 36 months, we aimed to recruit 400 patients. All the main analyses were based on intention to treat (ITT) and were done at the end of the trial. Signifi cance was set at 5% in the main analysis and 1% in the subgroup analyses. To assess the primary outcomes, we used a repeated measures mixed eff ects model to analyse the EQ-5D scores and intraocular pressure, 27 based on the follow-up data obtained at 6, 12, 24, and 36 months. tải về 315.39 Kb. Chia sẻ với bạn bè của bạn:
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