Brief Title
Selective Retina Therapy With Real-Time Feedback-Controlled Dosimetry for Treating Acute Idiopathic Central Serous Chorioretinopathy in Korean Patients
Official Title
Selective Retina Therapy With Real-Time Feedback-Controlled Dosimetry for Treating Acute Idiopathic Central Serous Chorioretinopathy in Korean Patients
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.
Detailed Description
Central serous chorioretinopathy (CSC) is a disorder that is characterized by a localized
serous detachment of the neurosensory retina in the posterior pole. Additionally, CSC is
often self-limiting and spontaneous resolution of subretinal fluid (SRF) often occurs within
several months. Although several treatment modalities (e.g., laser photocoagulation,
photodynamic therapy, and anti-vascular endothelial growth factor [VEGF] therapy have been
used in CSC patients, a consensus has not yet been reached on the optimal time for
intervention.
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.
When treating CSC patients, it is generally recommended to follow-up several months without
any intervention to identify spontaneous resolution of SRF. However, prompt treatment may be
beneficial for some patients. For example, metamorphopsia or micropsia associated with CSC
can greatly interfere with driving or with work when an occupation requires delicate
procedures. Additionally, patients are often psychologically distressed by a CSC diagnosis
and the accompanying decrease in vision-related quality of life. In these cases, prompt
treatment to reduce SRF may relieve, at least in part, CSC symptoms and their related stress.
The current study evaluated short-term treatment outcomes following SRT with real-time
feedback-controlled dosimetry in Korean patients with acute idiopathic CSC.
This study included patients who were diagnosed with treatment-naïve idiopathic CSC and were
treated with SRT. The R:GEN device (Lutronic, Goyang-si, South Korea) was used to administer
SRT. Inclusion criteria also included SRF involving the fovea (documented by optical
coherence tomography [OCT] performed at initial presentation) and symptom duration shorter
than 3 months. Patients were excluded from analyses if any of the following were true: (1)
age > 55 years, (2) clinical or angiographic features suggestive of choroidal
neovascularization, (3) OCT findings suggestive of type 1 neovascularization or polypoidal
choroidal vasculopathy (e.g., double layer sign or fibrovascular pigment epithelial
detachment), (4) history of macular laser photocoagulation, photodynamic therapy, or
anti-VEGF therapy, or (5) history of exogenous corticosteroid treatment for a systemic
disease (e.g., Cushing's syndrome or renal disease).
Examination, treatment, and follow-up All subjects underwent comprehensive ophthalmologic
examinations, including best-corrected visual acuity (BCVA) measurement, slit-lamp
biomicroscopy (90-diopter lens), fluorescein angiography (FAG), fundus photography, and
spectral domain OCT (Spectralis HRA-OCT™, Heidelberg Engineering, Dossenheim, Germany or RS
3000™, Nidek Co., Ltd., Tokyo, Japan). Indocyanine green angiography using a confocal
laser-scanning system (Spectralis HRA-OCT™) was performed at the discretion of each
physician. A CSC diagnosis was based on FAG findings, in particular, evidence of a typical
ink blot or smokestack leakage. A single examiner (J.H.K.) reviewed all FAG results.
All SRT was performed by a single physician (J.H.K.) using a Nd:YLF laser (wavelength of 257
nm, 15 micro pulses per spot, single micro pulse duration of 1.7 µs, pulse repetition rate of
100 Hz). Spot size was set at a diameter of 200 µm. Real-time feedback-controlled dosimetry
(RFD) detects ultrasonic pressure waves generated by intracellular bubble formation and was
used to determine optimal laser energy. Before applying laser energy to a leakage point, test
shots were made immediately outside of the superior or inferior temporal arcade.
Optimal laser energy was determined based on real-time feedback system indications on the
control panel. 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, as confirmed by the RFD system. If the control panel indicated that
excessive laser energy had been applied, the laser energy was decreased in 5-10 µJ increments
until the optimal energy delivery was again achieved (confirmed by RFD system). The total
number of laser shots delivered around fluorescein leakage points that were at or above the
optimal laser energy were counted.
Patients had follow-up visits 1 and 3 months after SRT, at which BCVA was measured and OCT
examination was performed. Central foveal thickness (CFT) was manually measured on OCT images
and was defined as the distance between the RPE and the internal limiting membrane.
Outcome measures Both BCVA and CFT were measured at diagnosis, at 1 and 3 months following
SRT, and at the final follow-up visit. The incidence of complete SRF resolution was
estimated. Color fundus photographs taken at each follow-up visit also documented laser
treatment and were used to check for the presence of visible laser spots. All BCVA
measurements were converted to the logarithm of the minimum angle of resolution (logMAR) for
data analyses.
Statistical analyses Statistical analyses were performed using a commercially available
software package (SPSS v. 12.0 for Windows; SPSS Inc., Chicago, IL). Comparisons between BCVA
and CFT measurements at different time points were performed using Wilcoxon signed-rank tests
with a Bonferroni correction. Statistical significance was defined as P ≤ 0.05.
Study Type
Interventional
Primary Outcome
Subretinal fluid
Secondary Outcome
Visual acuity
Condition
Central Serous Chorioretinopathy
Intervention
Selective retina therapy
Study Arms / Comparison Groups
Treatment arm
Description: Patients received selective retina therapy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
16
Start Date
January 1, 2017
Completion Date
October 1, 2017
Primary Completion Date
September 1, 2017
Eligibility 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).
Gender
All
Ages
20 Years - 55 Years
Accepts Healthy Volunteers
No
Contacts
, ,
Administrative Informations
NCT ID
NCT03339856
Organization ID
3-116571-AB-N-01
Responsible Party
Principal Investigator
Study Sponsor
Kim's Eye Hospital
Study Sponsor
, ,
Verification Date
November 2017