ISRCTN17742985已完成未知
Diabetic Macular Oedema and Diode Subthreshold Micropulse Laser (DIAMONDS): A pragmatic, multicentre, allocation concealed, prospective, randomised, non-inferiority double-masked trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 266
研究概览
简要总结
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30755274 protocol 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36541393/ (added 06/02/2023) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37852765/ Cost-effectiveness analysis (added 19/10/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patients with diabetic retinopathy and centre involving DMO, as determined by using spectral domain optical coherence tomography (SD-OCT), in one or both eyes with:
- •1. Central retinal subfield thickness of > 300 but < 400 microns as determined by SD-OCT due to diabetic macular oedema
- •2. Central retinal subfield thickness of < 300 microns provided that intraretinal and/or subretinal fluid is present in the central subfield (central 1 mm) related to diabetic macular oedema
- •3. Visual acuity of > 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent > 20/320)
- •4. Amenable to laser treatment, as judged by the treating ophthalmologist
- •5. Over 18 years of age
排除标准
- •Eyes of patients will not be included in the study if:
- •1. The macular oedema is due to causes other than diabetic macular oedema such as epiretinal membrane, vitreomacular traction, vein occlusion, or others
- •2. The eye is ineligible for macular laser treatment, as judged by the treating ophthalmologist
- •3. The eye has DMO and central subfield retinal thickness (CST) of > 400 microns.
- •4. The eye has active proliferative diabetic retinopathy (PDR) requiring treatment.
- •5. The eye has received intravitreal Anti- Vascular Endothelical Growth Factor (Anti-VEGF) therapy within the previous two months.
- •6. The eye has received macular laser treatment within the previous 12 months.
- •7. The eye has received intravitreal injection of steroids.
- •8. The eye has received cataract surgery within the previous six weeks
- •9. The eye has received panretinal photocoagulation within the previous 3 months
- •The patient:
- •1. Is on pioglitazone and the drug cannot be stopped 3 months prior to entering into the trial and for the duration of the study
- •2. Has chronic renal failure requiring dialysis or kidney transplant
- •3. Has any other condition that in the opinion of the investigator would preclude participation in the study (such as unstable medical status or severe disease that would make it difficult for the patient to be able to complete the study)
- •4. Has very poor glycemic control and started intensive therapy within the previous 3 months
- •5. Will use an investigational drug during the study
研究者
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