ACTRN12618000453280招募中未知
Progressive retinal nerve fiber layer (RNFL) thinning as a biomarker to guide intraocular pressure (IOP) lowering treatment in ocular hypertensives (OHT)
Prof Leung Kai Shun Christopher0 个研究点目标入组 310 人开始时间: 2018年3月28日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 310
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1) age more than or equal to 18 years;
- •2) best corrected VA is greater than or equal to 20/40
- •3) an average IOP is more than or equal to 23mmHg but less than 32mmHg in at least 1 eye an more than or equal to 21mmHg but less than 32mmHg in the fellow eye measured from 3 separate baseline visits within 6 months
- •4) gonioscopically open anterior chamber angles
- •5) 3 reliable VF results without VF defects, normal optic disc and RNFL configuration in clinical examination
- •6) no RNFL abnormalities(i.e. within the 95% normal ranges) in the OCT RNFL thickness deviation map
- •7) no prior history of surgical/laser procedure for IOP lowering and receiving no topical IOP-lowering medication.
- •8) IOP measurements for eligibility assessment are obtained after washout of prestudy topical IOP
排除标准
- •1) secondary causes of elevated IOP;
- •2) ocular or systemic diseases that may cause VF loss or optic disc abnormalities
- •3) high myopia (spherical error<-6.0D)
- •4) inability to perform reliable VF; suboptimal quality of SDOCT images
- •5) previous intraocular surgery other than uncomplicated cataract extraction
- •6) diabetic retinopathy/maculopathy.
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