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Subthreshold Laser Treatment Versus Threshold Laser Treatment for Symptomatic Retinal Arterial Macroaneurysm (RAM-SUB)

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ClinicalTrials.gov Identifier: NCT01301326
Recruitment Status : Completed
First Posted : February 23, 2011
Last Update Posted : February 23, 2011
Sponsor:
Information provided by:
IRCCS San Raffaele

Brief 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.

Condition or disease Intervention/treatment Phase
Aneurysm Device: subthreshold and threshold laser treatment Device: Threshold laser treatment Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Randomized Clinical Trial Comparing Subthreshold Laser Treatment Versus Threshold Laser Treatment for Retinal Arterial Macroaneurysm
Study Start Date : April 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Arm Intervention/treatment
Experimental: subthreshold laser treatment Device: subthreshold and threshold laser treatment
subthreshold laser treatment
Other Name: subthreshold
Active Comparator: threshold laser treatment Device: Threshold laser treatment
threshold laser treatment
Other Name: threshold



Primary Outcome Measures :
  1. change in central point thickness [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. change in visual acuity [ Time Frame: 6 months ]


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Ages Eligible for Study:   35 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01301326


Locations
Italy
IRCCS San Raffaele
Milano, MI, Italy, 20132
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Study Chair: Francesco Bandello, MD Department of Ophthalmology

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Francesco Bandello, Department of Ophthalmology
ClinicalTrials.gov Identifier: NCT01301326     History of Changes
Other Study ID Numbers: RAM-SUB
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: February 23, 2011
Last Verified: January 2011

Keywords provided by IRCCS San Raffaele:
retinal arterial macroaneurysm
laser treatment

Additional relevant MeSH terms:
Aneurysm
Vascular Diseases
Cardiovascular Diseases