Status:
COMPLETED
Selective Retina Therapy With 'R:GEN' in Patients With Central Serous Chorioretinopathy
Lead Sponsor:
LUTRONIC Corporation
Conditions:
Central Serous Chorioretinopathy
Eligibility:
All Genders
19-55 years
Phase:
NA
Brief 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. ...
Eligibility Criteria
Inclusion
- Male and female adult patients aged 19 or over and less than 55
- Patients who have had clinical symptoms of central serous chorioretinopathy over 3 months.
- Patients whose best corrected visual acuity (BCVA) is at least 20/200 based on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart (BCVA based on the ETDRS chart will be converted into logMAR)
- Patients with Sub-Retinal Fluid (SRF) that has been going into the fovea continuously
- Patients with ≥1 \~ ≤ 3 active leakage sites in Fundus Fluorescein Angiography (FA)
- Patients who are of child-bearing potential and have agreed to use a medically acceptable contraceptive method during the study period
- ☞Medically acceptable contraceptive method: Condom, oral contraceptive pills that have been continued for more than three months, contraceptive injection or implants or intrauterine contraceptive device
- Patients who voluntarily agree to participate in this study, and are willing to and able to follow the protocol.
Exclusion
- Patients with other retinal diseases such as choroidal neovascularization, polypoidal choroidal vasculopathy.
- Patients with the conditions that make laser therapy difficult such as cataract or vitreous cloudiness.
- Patients who have atrophy (diameter: ≥1000㎛) in the retinal pigment epithelium including the fovea.
- Patients who had undergone laser or photodynamic therapy for central serous chorioretinopathy prior to the study participation.
- Patients who have received steroid treatment (periocular, subtenon, intraocular) within the last one year
- Patients who have received intraocular injection of anti-Vascular Endothelial Growth Factor (anti-VEGF) agent within the last six months.
- Patients who have undergone ophthalmological surgery such as intraocular surgery or vitrectomy within the last six months.
- Patients who have taken medication for central serous chorioretinopathy such as acetazolamide, spironolactone, and kalidinogenase \[within the last two months\].
- Patients who have a history of allergy to fluorescein used for FA and indocyanine green used for ICG angiography.
- Female patients who are pregnant or breastfeeding.
- Patients with systemic diseases such as Cushing's syndrome, inflammatory diseases, uncontrolled hypertension and diabetes, liver diseases, kidney diseases.
- Patients who have pigment epithelial detachment that is directly related to the point of leakage with a diameter of more than 1000 μm.
- Patients who are considered ineligible for this study according to the investigator's judgment.
Key Trial Info
Start Date :
March 30 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2018
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT03758963
Start Date
March 30 2016
End Date
June 20 2018
Last Update
November 29 2018
Active Locations (6)
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1
Seoul National University Bundang Hospital
Seongnam-si, South Korea
2
Korea University Anam hospital
Seoul, South Korea
3
Nune Eye Hospital
Seoul, South Korea
4
Seoul National University Hospital
Seoul, South Korea