ACTRN12612000704897已完成未知
A multi-centre, randomised trial into the safety and efficacy of nanosecond microsurgical laser intervention in early age-related macular degeneration.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 360
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
- 50 Years 至 95 Years（—）
- 性别
- All
入选标准
- •Age 50 years and older, and less than 95 years. Best Corrected Visual Acuity (BCVA) of 6/12 (20/40) or better in each eye. Bilateral high-risk early AMD (AREDS Simplified Severity Scale, at least 2 risk factors) within an inner macular zone (a circle with a radius of 1500 microns centered on the fovea). A threshold sensitivity less than 25 dB at any point, within a customised grid, as measured using a Macular Integrity Assessment (MAIA) device, at the same location of the one eye on two separate occasions. Pupil dilation of 5mm or more in each eye. Fundus photographs, OCT and FAF images of adequate quality as assessed by the LEAD Image Reading Centre. Ability and willingness to consent, and be randomised, to 2RT or sham laser treatment, and all qualification and follow-up phases of the study.
排除标准
- •Any imaged retinal sign suggestive of geographic atrophy within the macula (a circle with a radius of 3000 microns centred on the fovea). Peri-papillary atrophy further than 1500 microns from the fovea is allowed.
- •CNV, or past treatment for CNV, in either eye.
- •Any other experimental treatment for AMD, excluding dietary supplements, received in the past 12 months or thought likely to chronically change the course of the participant’s retinal disease.
- •Any OCT image showing evidence of intraretinal fluid (cysts), or subretinal fluid for which CNV cannot be excluded as a cause.
- •A subfoveal pigment epithelial detachment/drusenoid detachment greater than 1000 microns in diameter in either eye.
- •Ocular disease in either eye, other than AMD, which may significantly compromise assessment of the retina, including;
- •Known hypersensitivity to fluorescein.
- •Previous retinal or ocular surgery, the effects of which may now or in the future complicate assessment of the progression of AMD.
- •Requirement for any systemic or ocular medication known to be toxic to the retina.
- •Sensitivity to the application of a contact lens.
- •Any history of prior laser surgery to the retina.
- •IOP of 26 mm Hg or higher, or if there is some reason to believe that the participant may have glaucoma, (e.g., history of the diagnosis of glaucoma, medical, surgical or laser intervention for the treatment of glaucoma, or disc/nerve fibre layer defects suggestive of glaucoma).
- •Significant cataract: Nuclear cataract Grade 2 or 3, cortical cataract Grade 2 or 3 or posterior subcapsular cataract Grade 2 or 3, by Simplified Cataract Grading System (WHO Cataract Grading Group).
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