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临床试验/NCT01301326
NCT01301326已完成3 期

Pilot Randomized Clinical Trial Comparing Subthreshold Laser Treatment Versus Threshold Laser Treatment for Retinal Arterial Macroaneurysm

IRCCS San Raffaele2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
25
试验地点
2
主要终点
change in central point thickness

研究概览

简要总结

Best treatment option of retinal arterial macroaneurysm is still controversial. A recent publication has shown that subthreshold laser treatment can be beneficial in improving visual acuity in eyes with symptomatic retinal arterial macroaneurysm. Aim of the study is to compare the effects of subthreshold laser treatment and threshold laser treatment in patients affected by symptomatic retinal arterial macroaneurysm.

详细描述

The treatment of RAM is controversial and at present there is no general consensus about the best approach. Spontaneous obliteration of RAM may occur over the follow-up, but the long persistence of blood or subretinal fluid may lead to progressive photoreceptor damage, with consequent irreversible visual impairment. More specifically, the presence of subretinal hemorrhage beneath the fovea leads to a diminished visual function.

Treatment is generally indicated for RAM associated with exudative manifestations involving the fovea which do not tend to resolve spontaneously. The most commonly employed approach is direct or indirect laser photocoagulation with visible end-point. Nevertheless, several complications may be associated with conventional threshold laser for macular lesions, including enlargement of laser scar, choroidal neovascularization, and subretinal fibrosis. In addition to these complications, arteriolar obliteration, increased retinal exudation and scarring, with possible retinal traction, have also been reported as possible sequelae of the laser photocoagulation of RAM.

Another approach for the treatment of RAM is based on the use of subthreshold laser treatment.

Subthreshold laser treatment has been proposed in an attempt to minimize the negative aspects of conventional grid laser photocoagulation and has achieved encouraging results, especially in macular oedema secondary to diabetic retinopathy, proliferative diabetic retinopathy, and branch retinal vein occlusion. The concept underlying the use of subthreshold laser treatment is to decrease the laser damage by reducing the duration of laser exposure and by using a subvisible clinical end point. A micropulse diode laser releases low energy micropulses in order to confine the energy to the RPE cells, with limited protein denaturation, avoiding lateral thermal spreading.

Aim of the study is to compare the effects of subthreshold laser treatment to those of threshold laser treatment in patients affected by symptomatic retinal arterial macroaneurysm.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Retinal arterial macroaneurysm, exudative manifestations involving the fovea (including: subretinal/intraretinal fluid, and/or hard exudates, and/or hemorrhages), best corrected visual acuity worse than 20/80 Snellen equivalent, corresponding to 0.6 LogMAR

排除标准

  • previous treatments for retinal arterial macroaneurysm, any other ocular disease

结局指标

主要结局

change in central point thickness

时间窗: 6 months

次要结局

  • change in visual acuity(6 months)

研究者

申办方类型
Other

研究点 (2)

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