Micropulse Diode Laser Treatment for Chronic Central Serous Chorioretinopathy

Study Overview
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Brief Summary
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The aim of this study was to evaluate safety and therapeutic response to micropulse diode 810nm laser treatment in patients with chronic central serous chorioretinopathy.

Detailed Description
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Most of the cases of central serous chorioretinopathy (CSC) recur spontaneously within three months of disease. After 3 months without resolution of acute CSC or in chronic CSC, continuous wave laser photocoagulation or photodynamic therapy should be considered. Direct threshold continuous photocoagulation treatment can shorten the duration of the serous detachment, but it is not appropriate for juxtafoveal or subfoveal leakage point.Subvisible photocoagulation potentially localizes and decreases chorioretinal thermic burn. Subthreshold diode micropulse (SDM) laser using a 810nm diode laser may spare the damage to the neural retina by raising the temperature of the RPE to just below the protein-denaturation threshold so that the thermal wave that reaches the neural retina is insufficient to cause neither damage nor clinically visible end-point. This therapeutic laser modality offers the possibility to minimize the iatrogenic retinal lesion.

Official Title
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Micropulse Diode Laser Treatment for Chronic Central Serous Chorioretinopathy: Evaluation by Fundus Autofluorescence and Spectral Domain Optical Coherence Tomography

Conditions
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Central Serous Chorioretinopathy

Intervention / Treatment
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* Procedure: Subthreshold diode micropulse laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic active central serous chorioretinopathy lasting more than 6 months Leakage at fluorescein angiogram Exclusion Criteria: Opacities of the clear refractive media of the eye Any intraocular surgery within the 6 months prior to study entry Prior vitrectomy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Subthreshold diode micropulse laser<br>Subthreshold diode micropulse laser in patients with chronic central serous chorioretinopathy | Procedure: Subthreshold diode micropulse laser<br> <br> |
| Sham Comparator: Sham<br>Sham group simulating the laser treatment | Procedure: Subthreshold diode micropulse laser<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity | Best corrected visual acuity measured by ETDRS chart at baseline, 1, 3, 6, 9 and 12 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular subretinal fluid | Central macular thickness measured by spectral-domain optical coherence tomography at baseline, 1, 3, 6, 9 and 12 months | 6 months | 
| Leakage at fluorescein angiogram | Leakage at fluorescein angiogram evaluated at baseline, 3, 6, 9 and 12 months | 6 months |