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临床试验/NCT05543564
NCT05543564已完成不适用

The Case for Selective Prophylactic Pan-retinal Photocoagulation in Moderate Non-Proliferative Diabetic Retinopathy in Ophthalmic Practice in Low- Resource Settings

Assiut University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
1
主要终点
BCVA

研究概览

简要总结

Diabetic retinopathy (DR) is a challenge to ophthalmic practice in communities with poor socioeconomic development. The COVID 19 pandemic has accentuated the challenge. DR is one of the leading causes of vision loss worldwide, estimated to account for 1.25% of moderate to severe visual impairment and 1.07% of blindness. Pan retinal photocoagulation (PRP) remains the gold standard treatment for preventing visual loss in PDR. Scatter photocoagulation is not recommended for eyes with mild or moderate non-proliferative diabetic retinopathy (NPDR) provided careful follow-up can be maintained,. When retinopathy is more severe, scatter photocoagulation should be considered and should not be delayed if the eye has reached the high-risk proliferative stage. As many as 27% of patients with moderate NPDR are estimated to progress to PDR in 1 year; therefore, they should be seen every 4 to 8 months. This ideal, good as it is, is not what ophthalmic practice has to deal with in communities of low-resource settings, where patients often seek medical advice due to visual complaints from the complications of PDR without being diagnosed in the non-proliferative stage or high risk PDR. Screening protocols are not followed, a situation aggravated during the COVID pandemic lockdown.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with moderate NPDR at high risk which includ:
  • Patients with PDR in the other eye
  • Patients whose Glycosylated Haemoglobin (HbA1c) more than 8 %.
  • Patients with early cataract
  • Patients on regular renal dialysis or with impaired renal function
  • Patients with restricted mobility because of neurological or orthopedic conditions
  • Patients dependent on others, including old age.
  • Women in rural areas, who are dependent on the accompaniment of a male relative.

排除标准

  • Any patient who or whose relatives confirmed their attendance for regular follow-up according to the planned schedules after being informed of the possible complications which could happen if he or she did not attend.
  • Patients with clinically significant macular edema (CSME).

结局指标

主要结局

BCVA

时间窗: 3 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Khaled Abdelazeem

Associate Professor

Assiut University

研究点 (1)

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