Theodorou Maria, Quartilho Ana, Xing Wen, Bunce Catey, Rubin Gary, Adams Gillian, Dahlmann-Noor Annegret
a Paediatric Ophthalmology and Strabismus , Moorfields Eye Hospital , London , UK.
b National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital , London , UK.
Strabismus. 2018 Mar;26(1):11-21. doi: 10.1080/09273972.2017.1418394. Epub 2018 Jan 15.
The optimal management of infantile nystagmus syndrome (INS) is still unclear. Contact lenses (CL) may be superior to glasses in improving visual function in INS but it is not known whether their beneficial effects are due to optical correction alone, or to an additional proprioceptive effect, and whether soft CLs would be as effective as rigid CLs. There is little data on feasibility and and the present study aimed to provide this information.
We completed a pilot Randomized Control Trial (RCT) at a single tertiary referral centre in London, UK. We enrolled 38 adults with idiopathic INS and randomised them to either plano CL (with corrective spectacles if required) or to corrective CL. CL wear was required for a minimum of 2 weeks. Primary outcome measures were feasibility and safety of CL wear in INS; secondary outcome measures were visual acuity and nystagmus waveform parameters.
27 completed the study (27/38,71%). 4 partcipants withdrew due to difficulty with CL insertion/removal and 7 were lost to follow up. CL tolerability was high (24/27,89%) - 2 found the CLs irritant, and 1 had an exacerbation of allergic eye disease. At two weeks, mean improvement in binocular visual acuity from baseline with plano CLs was 0.07 logMAR (95% confidence interval (CI: 0.03-0.11) and 0.06 logMAR with fully corrective CLs (95% CI:0.02-0.1). Mean improvement in the eXpanded Nystagmus Acuity Function (NAFX, a nystagmus acuity function based on eye movement recording) with plano CLs was -0.04(95% CI: -0.08-0.005) and -0.05 with fully corrective CLs(95% CI: -0.09-0.003).
CLs are well tolerated, with a low risk profile. Whilst our study was not powered to detect significant changes in BCVA and waveform parameters between treatment arms, we observed a trend towards an improvement in visual function at two weeks from baseline with CLs.
婴儿型眼球震颤综合征(INS)的最佳治疗方案仍不明确。在改善INS患者的视觉功能方面,隐形眼镜(CL)可能优于眼镜,但尚不清楚其有益效果是仅归因于光学矫正,还是另有本体感觉效应,以及软性CL是否与硬性CL效果相同。关于可行性的数据很少,本研究旨在提供此类信息。
我们在英国伦敦的一家单一的三级转诊中心完成了一项初步随机对照试验(RCT)。我们招募了38名特发性INS成人患者,并将他们随机分为平光CL组(必要时佩戴矫正眼镜)或矫正CL组。要求佩戴CL至少2周。主要结局指标是INS患者佩戴CL的可行性和安全性;次要结局指标是视力和眼球震颤波形参数。
27人完成了研究(27/38,71%)。4名参与者因CL插入/取出困难而退出,7人失访。CL耐受性良好(24/27,89%)——2人觉得CL有刺激性,1人过敏性眼病加重。两周时,平光CL组双眼视力较基线的平均改善为0.07 logMAR(95%置信区间(CI):0.03 - 0.11),完全矫正CL组为0.06 logMAR(95% CI:0.02 - 0.1)。平光CL组扩展眼球震颤视力功能(NAFX,一种基于眼动记录的眼球震颤视力功能)的平均改善为 - 0.04(95% CI: - 0.08 - 0.005),完全矫正CL组为 - 0.05(95% CI: - 0.09 - 0.003)。
CL耐受性良好,风险较低。虽然我们的研究没有足够的效力检测治疗组之间最佳矫正视力(BCVA)和波形参数的显著变化,但我们观察到从基线开始两周时CL使视觉功能有改善的趋势。