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MICROPULSE study aims to evaluate the efficacy of navigated microsecond laser (nMSL) for chronic central serous chorioretinopathy (CSCR).
Chronic central serous chorioretinopathy (CSCR) is characterized by persistent subretinal fluid (SRF) and extensive outer retinal damage on optical coherence tomography (OCT). In the last years several treatment modalities for chronic CSCR have been investigated. These treatments have included pharmacologic therapy, photodynamic therapy (PDT) and microsecond laser.
PDT is the main treatment for CSCR, especially for chronic CSCR. But the efficacy of PDT is variable and could be associated with various complications such as retinal pigment epithelium (RPE) atrophy. Furthermore other limitations of PDT are unavailability and high cost.
Recently some studies have suggested an efficacy of micropulse laser in chronic CSCR, with stabilization of visual acuity, improvement in retinal sensitivity and without any complications.
The present study aims to evaluate the efficacy of a treatment by guided micropulse laser in the management of chronic CSCR. The efficacity will be evaluated 6 weeks and 3 months after the treatment on anatomical outcomes (central macular thickness in microns)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| micropulse laser | Experimental | treatment with confluent spots over the area of focal leak on the earliest phase of fundus fluorescein angiography on Navilas® system using 5% duty cycle with 100 micron spot size with 200 ms envelope. Thirty percent of threshold laser burn power was used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| micropulse laser | Device | treatment with confluent spots over the area of focal leak on the earliest phase of fundus fluorescein angiography on Navilas® system using 5% duty cycle with 100 micron spot size with 200 ms envelope. Thirty percent of threshold laser burn power was used. |
| Measure | Description | Time Frame |
|---|---|---|
| central macular thickness | central macular thickness measured in microns and determined on spectral-domain OCT | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| central retinal thickness | central retinal thickness (micrometers) | Baseline, Month 3 |
| visual acuity | visual acuity via ETDRS (Early Treatment of Diabetic Retinopathy Study) scale. The EDTRS scale is expressed in number of letters read. The scale is logarithmic, i.e. the progression between the 14 lines is geometric (by a factor equal to the cube root of 2). A loss of 3 lines of visual acuity thus corresponds to a doubling of the visual angle.This allows to determine the necessary corrections (sphere, cylinder, axis |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D056833 | Central Serous Chorioretinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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|
| Baseline, Month 3 |
| eye sensitivity | eye sensitivity measured with microperimetry in decibels (dB) | Baseline, Month 3 |
| presence of sub-retinal fluid | presence of sub-retinal fluid on Spectral-Domain Optical Coherence Tomography (SD-OCT) | Baseline, Month 3 |
| presence of intraretinal cysts | presence of intraretinal cysts on SD-OCT | Baseline, Month 3 |
| presence of flat irregular pigment epithelium detachment | presence of flat irregular pigment epithelium detachment (FIPED) on SD-OCT | Baseline, Month 3 |
| presence of neovascularization | presence of type 1 neovascularization on OCT-angiography | Baseline, Month 3 |