Selective Retina Therapy With 'R:GEN' in Patients With Central Serous Chorioretinopathy
Condition: Central Serous Chorioretinopathy
MeSH terms: Central Serous Chorioretinopathy
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): R:GEN Selective Retina Therapy
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment