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Completed

NCT Number: NCT01301326

Subthreshold Laser Treatment Versus Threshold Laser Treatment for Symptomatic Retinal Arterial Macroaneurysm

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.

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Key information

Age range

35 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

IRCCS San Raffaele

Milan, MI, 20132, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

subthreshold and threshold laser treatment

Device

subthreshold laser treatment

Other names: subthreshold

Threshold laser treatment

Device

threshold laser treatment

Other names: threshold

Primary outcomes

  1. change in central point thickness

    Time frame: 6 months

Secondary outcomes

  1. change in visual acuity

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Acronym: RAM-SUB

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 23, 2011
Registry last updated
Feb 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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