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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Aneurysm

Intervention / Treatment
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* Device: subthreshold and threshold laser treatment
* Device: Threshold laser treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: subthreshold laser treatment<br> | Device: subthreshold and threshold laser treatment<br>* subthreshold laser treatment<br>* Other names: subthreshold;|
| Active Comparator: threshold laser treatment<br> | Device: Threshold laser treatment<br>* threshold laser treatment<br>* Other names: threshold;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in central point thickness |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in visual acuity |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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retinal arterial macroaneurysm, laser treatment