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

NCT03339856 | Completed

• 1 other identifier: 3-116571-AB-N-01
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Central Serous Chorioretinopathy

Outcome Measures

Primary Outcomes (1)

• Subretinal fluid

  Presence or absence of subretinal fluid which identified based on optical coherence tomography images.

  3 months after treatment

Secondary Outcomes (1)

• Visual acuity

  At diagnosis, at 1 month, and 3 months after treatment

Study Arms (1)

Treatment arm

EXPERIMENTAL

Patients received selective retina therapy

Device: Selective retina therapy

Interventions

Selective retina therapy DEVICE

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.

Treatment arm

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients diagnosed with treatment-naïve idiopathic central serous chorioretinopathy

You may not qualify if:

• 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).

Sponsors & Collaborators

• Kim's Eye Hospital: lead

Related Publications (1)

• Kim YJ, Lee YG, Lee DW, Kim JH. Selective Retina Therapy with Real-Time Feedback-Controlled Dosimetry for Treating Acute Idiopathic Central Serous Chorioretinopathy in Korean Patients. J Ophthalmol. 2018 Feb 6;2018:6027871. doi: 10.1155/2018/6027871. eCollection 2018.

  PMID: 29545953 DERIVED

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 13, 2017
• Study Start: January 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: January 2, 2019

Record last verified: 2017-11