The purpose of this clinical study is to evaluate the efficacy and safety of selective retina therapy (SRT) using R:GEN, an approved laser device, in patients with central serous chorioretinopathy.
In this study, treatment effect of each group will be evaluated by follow-up once a month of both study group and control group other than the 2nd month until 6 months following the first procedure. For the primary efficacy evaluation, the percentage of subjects who show complete removal of sub-retinal fluid (SRF) in Optical Coherence Tomography (OCT) results will be evaluated in the study group, before SRF therapy and at 3 months after therapy, and in control group, before sham procedure using R:GEN and at 3 months after therapy. In addition, for secondary efficacy evaluation, major symptoms of central serous chorioretinopathy will be evaluated at 3 and 6 months including changes in best corrected visual acuity (BCVA) on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, the degree of retinal functional damage, and changes in sub-retinal fluid (SRF) and central macula thickness (CMT) on OCT. At 6 months, removal rate of leakage on Fluorescene Angiography (FA) and recurrence of the disease will be evaluated to compare the recurrence rate of study group and control group undergoing sham procedure. The subjects in the study group who only meet the conditions of retreatment at 3 \~ 5 months after selective retina therapy (SRT) may receive SRT up to twice again. The subjects in the control group those who have not recovered naturally but have persistent clinical symptoms at 3 months will undergo SRT. And the subjects in the control group who only meet the conditions of retreatment at 5 months after SRT at 2 months. And the subjects in the control group, who have experienced complete disappearance of SRF at 3 months after Sham procedure, but SRF is observed again at 4 or 5 months, may receive SRT up to twice again. These subjects will be categorized into a separate subgroup and the efficacy and safety of SRT will be evaluated every visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
63
Selective Retina Therapy (SRT) is the treatment method using innovative laser technology with the wavelength absorbed by melanosomes such as laser photocoagulation, but due to short pulse width (1.7 µs) with 100 Hz repetition rate, Retinal Pigment Epithelium (RPE) cells may be destroyed only through the generation of microbubble around melanosomes (photomechanical action), and no thermal damage of normal cells or tissues may occur in the surrounding tissues. SRT influences the RPE wound healing, including migration and proliferation of RPE cells, which treats CSC in the mechanism of recovering RPE. Once RPE is recovered, the sub-retinal fluid may be pumped out and retinal function again recovered. Moreover, previous studies showed that SRT may stimulate a moderate increase of activated metalloproteinase (MMP), leading to the improvement of Bruch's membrane's transport property.
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Korea University Anam hospital
Seoul, South Korea
Nune Eye Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Sub-retinal Fluid (SRF) Removal Rate
The percentage of subjects (%) who show complete removal of Sub-retinal Fluid (SRF) on Optical Coherence Tomography (OCT) is compared between study group and control group.
Time frame: 3 months
Improvement of Best Corrected Visual Acuity
The improvement of Best Corrected Visual Acuity is evaluated using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart and is compared between study group and control group.
Time frame: 3, 6 months
Degree of Retinal Functional Damage
The degree of retinal functional damage is compared between study group and control group.
Time frame: 3, 6 months
Change in Sub-retinal Fluid (SRF)
The change in Sub-retinal Fluid (SRF) (μm, mm3) on Optical Coherence Tomography (OCT) is compared between study group and control group.
Time frame: 3, 6 months
Change in Central Macular Thickness
The change on Central Macular Thickness (CMT) (μm) based on Optical Coherence Tomography (OCT) results are compared between the study and control group.
Time frame: 3, 6 months
Removal Rate of Leakage
The percentage (%) of participants who show complete removal of leakage in Fluorescene Angiography (FA) results is compared between study group and control group.
Time frame: 6 months
Recurrence Rate
The percentage (%) of participants who show recurrence is compared between study group and control group
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The Catholic University of Korea Seoul ST.Mary's Hospital
Seoul, South Korea
The Catholic University of Korea Yeouido St.Mary's Hospital
Seoul, South Korea
Time frame: 6 months