Subthreshold Laser Treatment Versus Threshold Laser Treatment for Symptomatic Retinal Arterial Macroaneurysm
Condition: Aneurysm
MeSH terms: Retinal Arterial Macroaneurysm; Aneurysm
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): subthreshold and threshold laser treatment; Threshold laser treatment
Intervention type(s): Device; Device
Intervention description(s): subthreshold laser treatment; threshold laser treatment
Other intervention name(s): subthreshold; threshold
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: retinal arterial macroaneurysm; laser treatment