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临床试验/NCT04332133
NCT04332133已完成不适用

Anatomical and Functional Outcomes of Subthreshold Micropulse Laser Versus Intravitreal Ranibizumab Injection in Treatment of Diabetic Macular Edema

Minia University0 个研究点目标入组 80 人开始时间: 2016年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
主要终点
p1 amplitude of mfERG

研究概览

简要总结

The aim of this study is To compare the anatomical and functional results of intravitreal( IV) injection of ranibizumab with sub threshold micropulse laser ( SML) in treatment of Diabetic macular edema (DME) both anatomically by spectral domain optical coherence tomography (SD OCT) and functionally by best-corrected visual acuity (BCVA) and multifocal electroretinogram (mfERG).

详细描述

Diabetic macular edema (DME) causes significant visual loss in diabetic patients. About 20% and 40% of patients with Type 1 and Type 2 diabetes mellitus (DM), respectively, develop DME. One-third of diabetic patients who have had DM for more than twenty years will develop DME . Early impairment in the function of the middle and inner layers of the retina has been reported in diabetic patients before appearance of vascular complications . A good independent guide of macular function in patients with DME is multifocal electroretinogram (mfERG) readings from the macular area, which strongly associate with morphologic alterations in the macula. Some investigators suggested that temporal characteristic (implicit time) of mfERG waves are more important than amplitudes for evaluation of retinal function in diabetic patients. They concluded that patients with DM show temporal changes indicating delayed neural transmission due to local impairment of blood glucose metabolism. In contrast, others emphasize the importance of both parameters (implicit time and amplitude) in identifying retinal affection in DM.

Intravitreal (IV) injections of anti-vascular endothelial growth factor (VEGF) agents provided good visual outcomes in treatment of DME. However, IV anti-VEGF injections are expensive, need to be repeated many times and have the potential risk of causing endophthalmitis . Subthreshold micropulse laser (SML) treatment of DME has the same effect as conventional laser treatment, nonetheless, there is less damage to adjacent tissues of the burn area in the retinal pigment epithelium (RPE). SML allows laser emission to be divided into bursts of short cyclic pulses that remain for microseconds permitting substantial cooling amid these short pulses .

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 (Participant)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •DME with BCVA<0.5 decimal Snellen acuity.
  • •Controlled blood glucose (HbA1c) <6.5%.

排除标准

  • •History of previous intraocular surgery,
  • •History of previous laser treatment,
  • •History of previous IV injection,
  • •Macular disease or ischemia,
  • •Proliferative diabetic retinopathy,
  • •Vitreoretinal traction,
  • •Interruption of external limiting membrane (ELM) or ellipsoid zone (EZ).
  • •Dense media opacity,
  • •Optic disc pathology
  • •History of strokes or ischaemic heart diseases.
  • •patients with (CST) > 400 µm on OCT .

研究组 & 干预措施

group 3

No Intervention

control group of diabetic patients received no treatment

group 1

Active Comparator

group 1 of DME which treated by SML

干预措施: laser interference,INTRAVITREAL INJECTION (Procedure)

group 2

Active Comparator

Group 2 of DME which treated by intravitreal injection of Ranibizumab

干预措施: laser interference,INTRAVITREAL INJECTION (Procedure)

结局指标

主要结局

p1 amplitude of mfERG

时间窗: 6mnths

p1 amplitude of multifocal ERG measured in nv/deg2

central subfield thickness in micrometer

时间窗: 6 months

OCT for the macular area with measuring CST in micron

BCVA

时间窗: 6 months

BCVA is measured in decimal of Snellen visual acuity

次要结局

未报告次要终点

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Raafat Mohyeldeen Abdelrahman Abdallah

associate professor of ophthalmology

Minia University

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