Early Laser Treatment for Diabetic Eye Disease in China: The PEARL Pilot Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Proportion of eyes progressing to any degree of PDR
研究概览
简要总结
To compare immediate laser pan-retinal photocoagulation (PRP) treatment of severe or very severe non proliferative diabetic retinopathy (NPDR) stage versus deferral of treatment until the appearance of any proliferative diabetic retinopathy (PDR) in rural and urban patients in China.
Interview data from some patients and survey data from ophthalmologists in the study hospitals will help determine acceptability of early treatment, and how to overcome barriers to increased use of this option.
详细描述
China now has the world's largest number of diabetic persons. Population studies show that only 10% of Chinese rural-dwellers with DR receive therapy. The current standard approach to treatment of DR often requires patients to return for multiple examinations over years, before they reach trial-proven criteria for treatment. This long process is ill-suited to support good compliance with care in low-resource settings. Our recent published review suggests that earlier PRP treatment, which could reduce the burden of compliance, may be clinically effective and cost effective, but the current evidence base is insufficient to make a firm recommendation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged >= 18 years with untreated DR at severe or very severe NPDR stage in either one or both eyes, according to the clinical opinion of the investigator.
- •Sufficiently clear ocular media to allow visualization of the retina and retinal photography in either eye.
- •Capable of giving informed consent.
排除标准
- •DR at later stage of retinopathy than severe or very severe (eg, two or more of the 4-2-1 criteria are met) NPDR in either eye, but a patient may be enrolled if one eye has severe or very severe NPDR and the fellow eye has PRP-treated PDR and has been stable after treatment.
- •Clinically significant macular edema in either eye.
- •Dense cataracts or other media opacity preventing visualization of the retina in the eye.
- •History of previous surgical or laser treatment for DR or other retinal conditions in a study eye, including history of anti-VEGF or corticosteroid injection or focal laser for DME within 6 months, or any history of scleral buckle, vitrectomy or other retinal detachment repair.
- •History of other retinal vascular disorders including CRVO, CRAO, BRVO, BRAO in the study eye.
- •Previous cataract or glaucoma surgery is specifically allowed if performed ≥ 6 weeks prior to enrollment.
- •Pregnancy.
- •Severe renal insufficiency treated with hemodialysis treatment, kidney transplant, pancreatic transplant, and intensive insulin therapy initiated within 4 months.
- •Nystagmus, unable to cooperate with laser treatment.
结局指标
主要结局
Proportion of eyes progressing to any degree of PDR
时间窗: 1 year
The diagnosis of PDR will be made by detecting either active new vessels in the optic nerve head or elsewhere in the retina as determined by fundus photography read by a masked investigator or preretinal/vitreous haemorrhage at any time during the 12 month follow-up period.
次要结局
- Proportion of early versus standard treated eyes with: retinal detachment(1 year)
- Proportion of early versus standard treated eyes with: increase of diabetic macular edema per Optical Coherence Tomography(1 year)
- Proportion of early versus standard treated eyes with: Loss of >= 10 and of 15 ETDRS letters(1 year)
- Mean change in best corrected visual acuity from baseline to week 52.(1 year)
- Sensitivity & specificity of the diagnosis of any degree of PDR among study ophthalmologists(1 year)
研究者
Congdon Nathan
Professor
Sun Yat-sen University