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Selective Retina Therapy With Real-Time Feedback-Controlled Dosimetry for Treating Acute Idiopathic Central Serous Chorioretinopathy in Korean Patients

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ClinicalTrials.gov Identifier: NCT03339856
Recruitment Status : Completed
First Posted : November 13, 2017
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
Jae Hui Kim, Kim's Eye Hospital

Brief Summary:

Selective retina therapy (SRT) selectively disrupts the retinal pigment epithelium (RPE) with minimal damage to the photoreceptors. Previous studies have shown SRT to be effective for resolving SRF, while causing only minimal collateral damage to the retina and vision.However, most patients included in prior studies had chronic CSC (≥3 months symptom duration) and SRT efficacy on acute CSC is not fully known.

The current study evaluated short-term treatment outcomes following SRT with real-time feedback-controlled dosimetry in Korean patients with acute idiopathic CSC.


Condition or disease Intervention/treatment Phase
Central Serous Chorioretinopathy Device: Selective retina therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Selective Retina Therapy With Real-Time Feedback-Controlled Dosimetry for Treating Acute Idiopathic Central Serous Chorioretinopathy in Korean Patients
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment arm
Patients received selective retina therapy
Device: Selective retina therapy

The selective retina therapy (SRT) is a laser treatment to the retina using the R:GEN device (Lutronic, Goyang-si, South Korea).

Laser energy began at 80 µJ and was increased in 5-10 µJ intervals until the optimal energy delivery was confirmed by the RFD system. Following confirmation, the optimal laser energy was applied to fluorescein leakages. If the energy was indeed optimal at leakage points, laser shots were administered around the leakages. If the energy was not optimal at the leakage points, laser energy was again increased in 5-10 µJ increments until optimal energy delivery.





Primary Outcome Measures :
  1. Subretinal fluid [ Time Frame: 3 months after treatment ]
    Presence or absence of subretinal fluid which identified based on optical coherence tomography images.


Secondary Outcome Measures :
  1. Visual acuity [ Time Frame: At diagnosis, at 1 month, and 3 months after treatment ]
    Changes in logarithm of minimal angle of resolution visual acuity during the follow-up, which measured using visual acuity chart.



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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with treatment-naïve idiopathic central serous chorioretinopathy

Exclusion Criteria:

  • age > 55 years,
  • Clinical or angiographic features suggestive of choroidal neovascularization
  • Optical coherence tomography findings suggestive of type 1 neovascularization or polypoidal choroidal vasculopathy (e.g., double layer sign or fibrovascular pigment epithelial detachment).
  • History of macular laser photocoagulation, photodynamic therapy, or anti-vascular-endothelial growth factor therapy.
  • History of exogenous corticosteroid treatment for a systemic disease (e.g., Cushing's syndrome or renal disease).

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jae Hui Kim, Principal Investigator, Kim's Eye Hospital
ClinicalTrials.gov Identifier: NCT03339856     History of Changes
Other Study ID Numbers: 3-116571-AB-N-01
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases