Anatomical and Functional Outcomes of Subthreshold Micropulse Laser Versus Intravitreal Ranibizumab Injection in Treatment of Diabetic Macular Edema
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
control group of diabetic patients received no treatment
group 1
group 1 of DME which treated by SML
干预措施: laser interference,INTRAVITREAL INJECTION (Procedure)
group 2
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
Raafat Mohyeldeen Abdelrahman Abdallah
associate professor of ophthalmology
Minia University
